International Journal of Generic Drugs

ØNew Generic Drugs Drug Development

Pipeline

R & D
Off-Patent with niche products

by Year
S t r a t e g y

Dori Belle BA D/Pharm - General Secretary IAGIM

C anges taking place in the

pharmaceutical industry threaten to
reduce the return on R&D
R&D Strategy.
Ideally the product should be ready for
submission shortly after the pivotal batch
investment, even though the per capita
consumption of prescription drugs (US) stability has been successfully
has doubled over the past five years. completed.
Foremost is the Waxman Hatch This requires an effective management
legislation. It has the effect of providing planning that treats development through
up to 30 months of additional monopoly scale-up, to pivotal, process validation,
protection by allowing innovator and registration as one integrated
companies to delay generic entrants process. Products should be planned in
simply by filing a law suit within 45 days concert rather than individually.
after being notified that an ANDA has Pipeline Strategy
been filed (The paragraph clause).If A new product development portfolio
litigation continues for 30 months (few
should be balanced and contain not only
are settled sooner) the generic drug is
blockbusters but a prudent product
then entitled to final marketing approval
spread in most of the six underlying
by the FDA.
development categories:-
These changes -a decline in the generic ♦ Blockbusters (over US$ 500 - 2500 m)
dollar share from 11.4 in 1994 to 8.7 in
1998, an increase in the number of ♦ Major Products (over US$250 - 500 m)
generics per blockbuster or major
♦ Minor Products (over US$100 - 250 m)
product being approved in the first year
and pressures from healthcare payers - ♦ Drugs with No Approved ANDAs
make it increasing important to analyse
your R&D organisation's effectiveness.
♦ Lessor Products (between $50-100 m)
R&D is in fact a business and requires ♦ Niche Products (under US $50 m)
an organisational environment that Risk Strategy.
carefully:
♦ establishes a well balanced product A major product (with US $250m sales)
development pipeline launched the day after the
patent/exclusivity expiration date will
♦ Looks at least 5 -6 years ahead have its sales reduced to less than $30-
♦ allows for rapid in-house development 40 million per player once four or five
of the approved product pipeline generic firms come into the market - (i.e.
♦ Dovetails the registration process reduced to the niche level.)
side-by-side with product development.

http://www.locumusa.com International Journal 181 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent
Reports
ISSN 0793694X

Electronic < DOP Reports-on-Disk

Reports-on-:-the-Web
- Reports
e--

Drugs Under $100 million US Dollars

Year of Expiration - 1998
Drug Generic Patent Patent Exclusivity Patent Earliest 1998
ON-OFF Name Holder Expiry Expiry &
Generic 19991
Patent Marketer Exclusivity

Trade Generic NAME Patent # DATE CODES DATE USD$

(Mil)
Femstat Butoconazole Roche/ 3/7/95 3/7/95 Class 1
Nitrate. Expired
Syntex 7/28/95 3/7/97 Class 2
Zonalon Doxepin Genderm 7/26/00 NDF Class 1
HCl Expired
12/9/01 4/1/97 Class 3
Cesamet Nabilone Lilly 5/2/95 5/2/97 - Class 1
Expired
2/17/96 5/2/97 Class 3
Producil - Merck Co. 5/17/94 5/17/97 - Class 1
Expired
8/13/94 5/17/97 Class 3
Opcon-A Naphoxoline Bausch & 6/8/97 - NC Class 1
HCl Expired
Lomb NA 6/8/97 Class 4
Minizide Polythiazide Pfizer 12/19/95 - Class 1
Expired
7/8/97 7/8/97 Class 4
Adagen PegademaseB Enzon 12/18/96 - ODE Class 1
ovine Expired
7/28/97 7/28/97 Class 3
Hexalen Altretamine US 12/26/97 NA NCE Class 2
Expired
Bioscienc NA 12/26/97 ODE Class 2
e
Capozide Captopril Bristol 8/12/97 - - Class 4
Hydrochloro- Expired
Myers 12/27/97 12/27/97 Class 6
thiazide
Squibb
KEY
NA = Not Applicable NC = Not confirmed in 1998 ODE = Orphan Drug Exclusivity
NCE = New Chemical Entity NP = New Product NS = New Substance
NDF = New Dosage Form NC = New Combination NE = New Salt or Ester
USD $
Class 1 -<10m Class 2 -<25m Class 3 -<50m Class 4 -<75m Class 5 -<100m Class 6 ->100m
Note: Some Brand leader drugs products have been omitted due to non-availability of sales data which
will appear in the 2000/2001 DOP Report.

http://www.locumusa.com International Journal 182 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 1998 (<$100M)
Drug Generic Patent Patent Exclusivity Patent Earliest 1998
ON-OFF Name Holder Expiry Expiry & Generic 19991
Exclusivity
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Tonolate Dihydroxy- Sterling 2/6/96 2/6/98 Class 1
alpha-amino Expired
4/1/89 2/6/98 Class 2
methylbenzyl
Leustatin Cladribane JNJ/ 2/26/98 - NCE Class 2
Expired
Ortho NA 2/26/98 Class 4
Equestrolin NA Merck 3/21/95 3/21/98 Class 1
Expired
5/9/95 3/21/98 Class 4
Synanthic Antiiparasitic Roche/ 3/21/95 3/21/98 - Class 1
Benzene Expired
Syntex 12/29/92 3/21/98 Class 3
Chibroxin Norfloxacin Merck & 3/27/98 - - Class 1
Expired
Co. 2/16/98 3/27/98 Class 3
Ceredase Alglucerase Genzyme 4/5/98 - NCE Class 2
Injection Expired
NA 4/5/98 ODE Class 4
Cerebyx Fosphenytoin WLA / P 4/7/98 - NCE Class 1
Sodium Davis
Expired
NA 4/7/98 Class 3
Cefpiramide Cephalosporin Sumitomo 5/29/96 5/29/98 - Class 1
Sodium Heterocycle Expired
Chemical 9/8/95 5/28/98 Class 2
Pilopine NA Alcon 6/2/98 - - Class 2
Expired
HS 1/25/98 6/2/98 Class 2
Cibacalcin Calcitonin Ciba-Geigy 6/30/98 - - Class 1
Expired
6/9/89 6/30/98 Class 3
Orlaam Levomethadyl Roxane 7/9/98 - NCE Class 1
Actate HCl Expired
NA 7/9/98 Class 4
Inocor Amrinone Sanofi 7/31/98 U7 Class 2
Lactate Expired
Winthrop 4-072-746 11
Normodyne Labetalol Schering 8/2/98 - - Class 4
Expired
Trandate A7H 4-012-444 60 + 41
Tonocard Tocainide Astra - 12/2/97 9/9/98 - Class 1
HCl Merck
Expired
7/28/91 9/9/98 Class 3
Flumadine Rimantadine Forest 9/17/98 - NCE Class 2
Expired
Labs NA 9/17/98 Class 4
Nipent Pentostatin Parke- 10/11/98 ODE Class 1
Expired
Davis NA 10/11/98 Class 3
Rocaltrol Calcitriol Roche/ 9/30/97 - Class 3
Expired
Syntex 10/13/98 10/13/98 Class 5
DIDRONEL Etidronate P&G 3/3/98 - - Class 2
Disodoum Expired
4-254-114 17
CERVIDIL Dinoprostone Forest 12/14/10 3/30/98- - Class 2
Expired
Labs 5-269-321 NDF 29
Transderm Scopolamine Novartis 4/14/98 - - Class 2
Expired
SCOP 4-436-741 21
Tagamet Cimetidine SKB - 6/19/98 - Class 3
Expired
HB - NS 44
Caverject Alprostadil Pharmacia 3/16/97 7/6/98 - Class 3
Expired
4-127-188 NP 34

INDUSTRY DRIVER: A WAVE OF PATENT EXPIRATIONS Close to $35 billion in brand sales is coming
off patent between 1999 - 2005. The dollar value of drugs coming off-patent over the next five years is
unprecedented and the generic prescription market should continue to grow driven by this new wave of
patent expirations.

http://www.locumusa.com International Journal 183 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration – 1998 - (<$100M)
Drug Generic Patent Patent Exclusivity Patent Earliest 1998
ON-OFF Holder &
Name Expiry Expiry Exclusivity Generic 19991
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Flumadine Rimantadine Forrest - 9/17/98 - Class 4
Expired
- NCE 60
Metro Metronidazole // - Class 2
Expired
Cream 4-- NCE 15
ORUDIS Ketoprofen AHP - 1-/06/98 - Class 1
Expired
KT 20-429 NS 9.5
FEMSTAT Butoconozole P&G 3/7/97 12/21/98 - Class 2
nitrate Expired
3 4-078-071 NP 12
Dermadex Torsemide B Mann 8/11/06 8/23/98 - Class 4
Expired
RE-34-672 NCE 57

USD $
Class 1 -<10m Class 2 -<25m Class 3 -<50m Class 4 -<75m Class 5 -<100m Class 6 ->100m
NA = Not Applicable NC = Not confirmed in 1998 ODE = Orphan Drug Exclusivity
NCE = New Chemical Entity NP = New Product NS = New Substance
NDF = New Dosage Form NC = New Combination NE = New Salt or Ester
Note: Some Brand leader drugs products have been omitted due to non-availability of sales data which
will appear in the 2000/2001 DOP Report.

US 2000 Pharmaceutical Industry value is just over US$100 billion The average annual
consumption of 270 million Americans is just exceeding S400 per person (In 1994 the amount
was $200)

CBI Conference
ANNOUNCEMENT
24-25th January 2000
The Westin Grand Washington DC

International Generic Drugs

FOR PRICING COMPETITION & REGULATIONS
nn Keynote Address nn
THE HONORABLE
HENRY A. WAXMAN
US Congressman Ca.

PLUS Pre-conference Workshop

n Sourcing API to meet Consumer Demand

http://www.locumusa.com International Journal 184 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 1999 (<$100M)
Drug ON- Generic Patent Patent Exclusivity Patent Earliest 1998
or OFF Name Holder Expiry Expiry & Generic 19991
Marketer Exclusivity
Patent (Millions)
Trade Generic NAME Patent # DATE CODES DATE USD$
Didronel Etidronate Procter & 3/3/98 - - Class 3
Disodium Gamble 1/2/98 1/2/99 Class 4
Maxair Pirbuterol 3M Phar- 11/20/96 - - Class 3
Acetate maceuticals 1/3/99 1/3/99 Class 4
Tussionex Chlorphe- Rhone - 9/9/97 - - Class 3
Penntuss niramine Poulenc 1/8/99 1/8/99 Class 5
Corsy Polistirex Rorer
Kerlone Betaxolol Searle 1/19/99 - - Class 2
10/20/96 1/19/99 Class 4
Rhinocort Budesonide Astra 2/14/ 99 2/14/99 NCE 2/14/99 Class 5
Zen - 80
Alfenta Alfentanil JNJ/ 5/5/99 Class 1
Inj. Jansen 4-167-574 5
Nizoral Ketoconazole JNJ / 6/15/99 - I-30 Class 5
Jansen 1/31/97 6/15/99 Class 6
Acesulfame Acetosul- Hoechst- 6/12/96 6/12/98 - Class 1
Potassium pham, etc., Roussel 6/22/97 6/22/99 Class 3
Tornalate Bitolterol Dura 6/22/99 - - Class 1
mesylate Pharm. 4/1/89 6/22/99 Class 3
Virazole Ribavirin ICN 7/8/97 7/8/99 - Class 3
Pharm. 6/1/91 7/8/99 Class 5
Betoptic Betaxolal Alcon 7/24/99 - - 4/24/99 Class 3
S HCl 4-252-984 55
Betoptic Betaxolal Alcon 7/24/99 - - 4/24/99 Class 2
HCl 4-252-984 22
Tegison Etretinate Roche 7/29/97 7/29/99 - Class 2
Syntex 3/22/94 7/29/99 Class 5
Alkeran Melphalan Burroughs 3/5/08 - ODE Class 1
Wellcome 11/18/08 11/18/99 Class 3
Normo- Labetalol Schering - 5/4/99 - - Class 4
dyne Key 11/28/99 11/28/99 Class 6
Luvox Fluvoxamine U.S. 4/18/95 - NCE Class 1
Maleate Phillips 3/19/96 12/5/99 Class 4
Carnitor Levocarnitine Sigma Tau - 12/16/99 I-86 Class 2
12/16/99
19-948 ODE 33
Osmovist Iotrolan Schering 12/16/97 12/16/99 - Class 1
AG 6/14/97 12/16/99 Class 3
Marinol Dronabinol Roxane 12/22/99 - I-85 Class 2
BI NA 12/22/99 ODE Class 0
Ceradon Cephalosporin Takeda 12/23/97 12/23/99 - Class 1
Dihydrochloride
8/29/97 12/23/99 Class 3
Navelbine Vinorelbine Burroughs 12/23/99 - NCE Class 1
Tartrate Wellcome NA 12/23/99 Class 4
Omnipaque Iohexal Sanofi 2/10/98 12/26/99 I-97 Class 1
Winthrop 6/10/97 12/26/99 Class 3
Mefoxin Cefoxitin Merck & 8/1/99 -- - 8/1/99 Class 2
Sodium Inj. Co. NA 27

Note: Some Brand leader drugs products have been omitted due to non-availability of sales data which
will appear in the 2000/2001 IAGIM DOP Report.

http://www.locumusa.com International Journal 185 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration – 1999 (<$100M)

Drug Generic Patent Patent Exclusivity Patent Earliest 1998

ON-OFF Name Holder Expiry Expiry &
Generic 19991
Exclusivity Milllions
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
NAPRILAN Naproxin Na AHP 16/10/14 1/5/99 - Class 5
5-637-320 NDF 80
Procanbid Procain- WL - 1/31/99 - 1/31/99 Class2
amice HCl - NP 13
CO-VERA Verapamil Monsanto 6/27/11 2/26/99 - 2/26/99 Class 5
HS HCl Searle 5-252-338 NP 78
ACTIGALL Ersodiol Bil Therap - 3/29/99 - 3/29/99 Class 4
19-594 I-147 62
Nasacort Triamcinolon RPR - 5/20/99 - 5/20/99 Class 4
AQ e Acetonide - NDF 52
Fortaz Glaxo - Ceftazidime 6/24/99 6/24/99 Class 5
Wellcome 4-258-041 78
Nicoderm Nicotine SKB - 8/2/99 - 8/02/99 Class 4
CQ - NP 74
Norcuron Vecuronium Akzo 8/20/99 - - 8/20/99 Class 2
Bromide Org 4-297-351 17
Lac-Hydrin Ammonium Westwood 8/29/99 - 8/29/99 Class 4
Lactate NDF 65
NIX Permethrin WL -- 11/1/99 - 11/1/99 Class 2
170 24
Vanceril Beclomethason S Plough 12/21/99 - Class 4
e Diproprionate
12/21/99
DS 4-364-923 - 66
Vancenase Beclomethason S Plough 12/21/99 - Class 3
e Diproprionate
12/21/99
4-364-923 - 52
Beclovent Beclomethason Glaxo - Wel 12/21/99 - Class 2
e Diproprionate
12/21/99
4-364-924 - 42
Marinol Dronabinol Roxane - 12/22/99 - Class 2
12/22/99
- - ODE 23
Acular Ketorolac Allergan 5/5/09 12/31/99 U-55 Class 2
Tromethamine
12/31/99
5-110-493 - I-176 44

KEY

USD $
Class 1 -<10m Class 2 -<25m Class 3 -<50m Class 4 -<75m Class 5 -<100m Class 6 ->100m

NA = Not Applicable NC = Not confirmed in 1998 ODE = Orphan Drug Exclusivity

NCE = New Chemical Entity NP = New Product NS = New Substance

NDF = New Dosage Form NC = New Combination NE = New Salt or Ester

Note:
Some Brand leader drugs products have been omitted due to non-availability of sales data which will
appear in the 2000/2001 IAGIM DOP Report.

http://www.locumusa.com International Journal 186 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 2000 (<$100M)

Drug Generic Patent PATENT Exclusivity Patent Earliest 1998

ON-OFF Name Holder Expiry Expiry &
Generic 19991
Exclusivity
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Sular Nisoldipine Astra 06/08/08 02/02/00 - 02/02/00 Class 3
Zeneca 4-892-741 - NCE 44
Ocupress Carteolol Otsuka 01/02/00 - - 01/02/00 Class 2
4-309-432 - - 18
Retin-A- Tretinoin Johnson & 10/04/05 02/07/00 - 02/07/00 Class 3
Micro Johnson 4-690-825 - NP 37
Leustatin Cladribane Johnson & - 02/26/00 - 02/26/00 Class 2
Johnson P NCE,ODE 13
Condylox Podofilox Watson 06/14/04 03/13/00 - 03/13/00 Class 2
4-680-399 NDF 15
Zebeta Bisoprolol AHP/Ledeele 03/24/00 07/31/97 U-63 03/24/00 Class 1
fumarate 4-258-062 NCE 9
Hismanal Astemizole Johnson & 04/03/00 - - 04/03/00 Class 3
Johnson 4-219-559 - 31
Novantrone Mitoxantrone AHP/ACY 07/14/00 - - 07/14/00 Class 3
4-278-689 - - 50
Loprox Ciclopirox Hoechst- - 07/21/00 - 07/21/00 Class 2
Marion P NDF 12
Roussel
Niaspan Niacin Cos - 07/28/00 - 07/28/00 Class 2
Pharmaceuticals P NDF 17
Cytotec Misoprostol Monsanto/ 07/29/00 - - 07/29/00 Class 4
Searle 4-301-146 - 72
Oxistat Oxiconazole Glaxo- - 08/18/00 - 08/18/00 Class 2
Nitrate Welcome P - I-200 15
Pepcid AC Famotidine Merck & 10/15/00 04/28/98 - 10/15/00 Class 5
Co. 4-283-408 NS 105
Flagyl ER Metronidaz Monsanto/ - 11/26/00 - 11/26/00 Class 2
ole Searle P NDF 18
Noroxin Norfloxacin Merck & 02/16/00 10/24/97 - 02/16/00 Class 3
Co. 4-146-719 I-113 34
Azelex Azelaic Allergan 05/31/00 09/13/00 U-124 09/13/00 Class 1
Acid 4-386-104 - NCE 17
Univasc Moexipril Schwarz 10/03/00 04/19/00 - 10/03/00 Class 2
HCL 4-344-949 NCE 25
Trasylol Aprotinin Bayer - 08/28/01 - 12/29/00 Class 3
Bovine P NCE,ODE, 47
I-233

USD $
Class 1 -<10m ; Class 2 -<25m ; Class 3 -<50m ; Class 4 -<75m ; Class 5 -<100m USD $

http://www.locumusa.com International Journal 187 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration – 2001 (<$100M)
Drug Generic Patent Patent Exclusivity Patent Earliest 1998
ON-OFF Name Holder Expiry Expiry & Generic 19991
Exclusivity
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Primacor Milrinone Sanofi 02/02/01 - - 02/02/01 Class 5
Winthrop 4-313-951 - 100+
Mesnex Mesna Asta - 03/06/01 - U-21 03/06/01 Class 3
Werke 4-220-660 - 35
Estratab Estrogens, Solvay - 03/10/01 - 03/10/01 Class 3
esterified P I-214 24
Differin Adapalene Galderma 04/10/01 05/31/01 U-134 05/31/01 Class 4
4-717-720 NCE 75
Stadol Butorphanol Bristol- 08/07/01 - U-60 08/07/01 Class 2
tartrate Myers /A4-464-378 - 18
Squibb
Alphagan Brimonidine Allergan - 09/06/01 - 09/06/01 Class 5
tartrate P NCE 92
Proamatin Midazolam Roberts - 09/06/01 - 09/06/01 Class 2
e Pharmaceutical NCE 12
P
Eulexin Flutamide Schering 09/18/01 06/21/99 U-24 09/18/01 Class 4
4-472-382 I-168 73
Nilandron Nilutamide Hoeschst- - 09/19/01 - 09/19/01 Class 2
Marion P NCE 12
Roussel
Roxicodone Oxycodone Roxane - 10/26/01 - 10/26/01 Class 2
hydrochlorid Laboratories P NS 12
e
Terazol Terconazole Johnson & 11/09/01 - - 11/09/01 Class 5
Johnson 4-358-449 - 100+
Rocaltrol Calcitriol Roche - 11/20/01 - 11/20/01 Class 3
P NDF 39
Zanaflex Tizanidine Elan - 11/27/01 - 11/27/01 Class 3
HCl P NCE 28
Chymo- Chymopapain Knoll 05/13/01 - - 05/13/01 Class 1
diactin 4-439-423 - 2
Tri-Norinyl Ethinyl Roche 08/10/01 - - 08/10/01 Class 3
Estradiol Syntex 4-390-531 - 36
Elocon Mometasone Schering 09/18/01 - - 09/18/01 Class 4
Furoate 4-472-393 P 85
Vaseretic Enalapril Merck & 09/18/01 07/12/98 - 09/18/01 Class 4
Maleate Co. 4-472-380 NS 73
Oxsoralen- Methoxsalen ICN 12/20/01 - - 12/21/01 Class 1
Ultra Pharm. 4-454-152 - 11

USD $
Class 1-<10m ; Class 2-<25m ; Class 3-<50m ; Class 4-<75m ; Class 5-<100m Class 6->100m USD $

http://www.locumusa.com International Journal 188 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 2002 (<$100M)
Drug ON- Generic Patent Patent Exclusivity Patent Earliest 1998
OFF Holder Expiry & 19991
Name Expiry Generic
Patent Exclusivity
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Gastrocrom Cromolyn Rhone 05/07/02 - - 05/07/02 Class 1
Sodium Poulenc 4-515-805 - 3
Rorer
Photoplex Avobenzone Allergan 06/07/02 - - 06/07/02 NA
4-387-089 -
Cardiogen- Rubidium Bristol - 08/23/02 - - 08/23/02 NA
82 Chloride Myers 4-400-358 -
Squibb

Nimotop Nimodipine Bayer AG 09/27/02 - U-22 09/27/02 Class 2

4-406-906 - 23
Proleukin Aldesleukin Chiron 10/18/02 - - 10/18/02 Class 3
4-518-584 - 50
Sandostatin Octreotide Novartis 10/21/02 05/03/97 - 10/21/02 Class 5
Acetate 4-395-403 I-106 85
Cefotan Cefotetan Stuart 11/21/99 - - 01/12/02 Class 4
disodium 4-263-432 - 53
Coreg Carvedilol Smith 03/05/02 09/14/00 U-3 03/05/02 Class 5
Kline 4-503-067 NCE 100+
Beecham
Agrylin Anagrelide Roberts - 03/14/02 - 03/14/02 Class 2
HCl - NCE,ODE 17
Tazorac Tazarotene Allergan 02/18/09 06/13/02 U-193 06/13/02 Class 2
5-089-509 NCE 17
Dostinex Cabergolin Pharmacia 07/02/02 12/23/01 - 07/02/02 Class 2
e &Upjohn 4-526-892 NCE 22
Navelbine Vinorelbine Glaxo- 07/08/02 12/23/99 - 07/08/02 Class 4
tartrate Wellcome 4-307-100 NCE 63
Duract Bromfenac AHP/Wyeth - 07/15/02 - 07/15/02 Class 3
sodium Ayerst - NCE 35
Nolvadex Tamoxifen Astra 08/20/02 - - 08/20/02 Class 5
citrate Zeneca 4-536-516 - 85
Anzemet Dolasetron Hoechst - 09/11/02 - 09/11/02 Class 3
nesylate Marrion - NCE 42
monohydrot Roussel
e
Axiz AR Nizatidine Eli Lilly 10/02/02 05/09/99 - 10/02/02 Class 2
4-375-547 NS 22
Cytoxan Cyclophosp Bristol-M 11/12/02 - - 11/12/02 Class 3
hamide Squibb 4-537-883 - 37
Delaying Tactics: FDA interpretation of the paediatric six month exclusivity provisions of the FDA
Modernization Act has additionally extended the patent protection for ALL DOSAGE FORMS of the drug -
not just the drug product used in the paediatric clinical trials. Under the FDA Modernization Act provisions
- a pharmaceutical product can attain and extra SIX month (additional) marketing exclusivity, if clinical
studies are conducted on a Paediatric Population.

http://www.locumusa.com International Journal 189 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration – 2002 (<$100M)

Drug ON- Generic Patent Patent Exclusivity Patent Earliest 1998

OFF Holder Expiry & 19991
Name Expiry Generic
Patent Exclusivity
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Prandin Repaglinide Novo 10/06/06 12/22/02 - 12/22/02 Class 3
Nordisk 5-216-167 NCE 31
Rilutek Riluzole Rhone- - 12/23/02 - 12/23/02 Class 3
Poulenc P NCE,ODE 24
Rorer
Optiray Ioversol Mallinkrodt 12/30/02 - - 12/30/02 Class 4
350 4-396-598 - 59

Whether your firm is an

INNOVATIVE or a Generic Company
This key conference is for you!
nd
WHEN 1 - 2 March 2000
WHERE -Thistle Westminster Hotel London

Profiting & Competing

IN THE EUROPEAN GENERIC INDUSTRY

n Plus PostRDConference Workshop

3 MARCH 2000

Basic Principles of Designing

a Successful Bioequivalence Study

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http://www.locumusa.com International Journal 190 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 2003 (<$100M)
Drug ON- Generic Patent Patent Exclusivity Patent Earliest 1998
OFF Holder Expiry & 19991
Name Expiry Generic
Patent Exclusivity
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Fludara Fludarabine Berlex 02/24/03 04/18/98 - Class 3
Phosphate 4-357-324 ODE 46
02/24/03
Brevibloc Esmolol BOC Gr 06/03/03 - - 06/03/03 Class 2
HCl Ohmeda 4-593-119 - 25
Decabid Indecainide Lilly 06/05/03 - - 06/05/03 -
4-452-745 -
Dynacirc Isradipine Novartis 08/21/03 - U-3 08/21/03 Class 3
4-466-972 - 44
Dynacirc Isradipine Novartis 08/21/03 - - 08/21/03 Class 2
CR 4-466-972 - 13
Renormax Spirapril Schering 09/11/03 12/29/99 U-3 09/11/03 -
HCl 4-470-972 NCE
Sildimac Silver NA 01/07/03 - - 01/07/03 -
Sulfadiazinc -
4-563-184
Serax Oxazepam AHP 11/04/03 - - 11/04/03 Class 1
Wyeth - 4-620-974 - 7
Ayerst
Blenaxane Bleomysin Bristol-M - 02/20/03 - Class 2
sulfate Squibb P OdE 02/20/03 24
Xeloda Capecitabine Roche - 04/30/03 - 04/30/03 Class 2
P NCE 24
Advil Cold Ibuprofen AHP/Wyeth 05/12/ 03 *PED - - - Class 3
and Sinnus -Ayerst 4-552-899 - 05/12/03 26
Diprolene Betamethasone Schering- - Class 3
05/13/03 - 05/13/03
Dipropianate
Plough 4-489-070 - 34
Diprolene Betamethasone Schering- - Class 3
12/09/03 - 12/09/03
Dipropianate
AF Plough 4-489-071 - 45
Ocuflox Ofloxacin Allergan 05/10/00 05/22/03 - 05/22/03 Class 3
4-382-892 ODE 34
Celexa Citalopram Forest - 07/17/03 - Class 3
Hydrobromide
07/17/03
Lab. P NCE 45
Renova Tretinoin Johnson & 07/29/03 12/28/98 U-131 07/29/03 Class 3
Johnson 4-603-146 NDE 26
Lotensin Benazepril Novartis 08/12/03 - - 08/12/03 Class 3
HCT 4-410-521 - 54
Serostim Somatropin Ares - 08/23/03 - 08/23/03 Class 3
biosynthetic Serono P ODE 37

Tentative Approvals A notable trend over the past year has been the dramatic increase of in FDA
tentative versus full marketing approvals. Tentative approvals are granted by the FDA when all the
technical CMC requirements for the ANDA have been met and the drug is deemed bioequivalent (AB
Rated). However the product may not be marketed because of a patent or exclusivity period may still be in
force or a pending or successful challenge by the brand leader to delay the generic competition.

http://www.locumusa.com International Journal 191 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration – 2003 (<$100M)

Drug ON- Generic Patent Patent Exclusivity Patent Earliest 1998

OFF Holder &
Name Expiry Expiry Exclusivity Generic 19991
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Topamax Topiramate R.W. 09/26/03 12/24/01 - 09/26/03 Class 4
Johnson 4-513-006 NCE 64
Abelcet Amphotericin B Liposome - 10/18/03 - Class 3
10/18/03
P ODE 47
Cutivate Fluticasone Glaxo- 11/14/03 - - 11/14/03 Class 2
propionate Welcome 4-335-121 - 16
Copaxone Glatiramer Teva - 12/20/03 - 12/20/03 Class 3
acetate Marion P NCE,ODE 53

Year of Expiration - 2004 (<$100M)

Protropin Somatrem Genentech 04/14/04 - - 04/14/04 Class 1
4-658-021 - 4
Ciloxan Ciprofloxacin Alcon 06/02/04 03/30/01 U-223 06/02/04 Class 3
HCl 4-670-444 NDF 36
Adenocard Adenosine Fujisawa 06/16/04 - U-38 06/16/04 Class 2
4-673-563 - 22
Ergamisol Levamisole Johnson & 06/19/04 - U-42 06/19/04 Class 1
Johnson 4-584-305 - 6
Dipentum Olsalazine Pharmacia 08/04/04 - U-58 08/04/04 Class 2
Sodium Adria 4-559-330 - 14
Tambocor Flecainide 3M 02/10/04 - - 02/10/04 Class 3
acetate Pharm 4-642-384 - 45
Maxair Pirbuterol 3M 05/12/04 - - 05/12/04 Class 2
acetate Pharm 4-664-107 - 21
Ambisome Amphoteracin Fujisawa - 08/11/04 - 08/11/04 Class 2
B P ODE 20
Aldara Imiquimod 3M Pharma 08/25/04 02/27/02 U-172 08/25/04 Class 3
Ceuticals 4-689-338 NCE 29
Lariam Mefloquine Roche 10/01/04 - - 10/01/04 Class 3
HCl 4-579-855 - 28
Romazicon Flumazenil Roche 10/10/04 - - 10/10/04 Class 3
4-316-839 - 35
Genotropi Somatropin Pharmacia - 10/31/04 - 10/31/04 Class 4
n biosynthetic Upjohn P ODE 27
Livostin Levocabastine Novartis 12/02/04 11/10/98 - 12/02/04 Class 2
HCl 4-369-184 NCE 25
Ultravate Halobetasol Bristol-M 12/17/04 - - 12/17/04 Class 3
Proprionate Squibb 4-619-921 - 41
Vicoprofen Hydrocodone Knoll 12/18/04 09/23/00 U-55 12/18/04 Class 3
Bitratrate 4-587-252 NC 46
TOBI Tobramycin Pathogenesis - 12/22/04 - Class 3
12/22/04
* ODE 45

http://www.locumusa.com International Journal 192 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 2005 (<$100M)
Drug Generic Patent Patent Exclusivity Patent Earliest 1998
ON-OFF Name Holder Expiry Expiry &
Generic 19991
Exclusivity
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Testoderm Testosterone Alza 02/16/05 - - 02/16/05 Class 1
Corp. 4-867-982 - 3
Nuromax Doxacurium Glaxo 03/06/05 12/08/97 - 03/06/05 Class 1
Chloride Wellcome 4-701-460 I-121 1
Ganite Gallium Sloan 01/17/05 01/17/98 U-49 01/17/05 Class 1
Nitrate Keterring 4-529-593 ODE 1
Survanta Beractant Abbott 07/01/05 07/01/98 - 07/01/05 Class 4
4-397-839 ODE 67
Fragmin Dalteparin Pharmacia 01/04/05 12/22/99 - 01/04/05 Class 2
Sodium Upjohn 4-303-651 NCE 14
Salagen Pilocarpine MGI - 02/11/05 - 02/11/05 Class 2
HCl Pharma - ODE 13
Ultravist Iopromide Berlex 03/06/05 05/10/00 U-13 03/06/05 Class 2
4-364-921 NCE 17
Amaryl Glimepiride Hoechst- 04/06/05 11/30/00 U-118 04/06/05 Class 4
Marion 4-379-785 NCE 64
Roussel
Fentanyl Fentanyl AHP 05/01/05 - U-87 05/01/05 Class 1
Citrate Wyeth 4-671-953 - 20
Ayerst
Cytovene Ganciclovir Roche 06/24/05 10/27/98 - 06/24/05 Class 4
Sodium 4-642-346 I-140 80
Lupron Leuprolide TAP 07/03/05 04/16/00 - 07/03/05 Class 3
Depot Ped acetate Pharm. 4-677-191 ODE 28
Lexxel Enalapril Merck & 10/07/05 12/27/99 - 10/07/05 Class 1
maleate Co 4-703-038 NC 11
Cholybar Cholestyr- Warner - 10/18/05 - - 10/18/05 NA
amine Wellcome 4-778-676 -

Profiting & Competing

IN THE EUROPEAN GENERIC INDUSTRY
WHEN 1 - 2nd March 2000
WHERE -Thistle Westminster Hotel London

n Plus Post Conference Workshop

3RD MARCH 2000

Basic Principles of Designing

a Successful Bioequivalence Study

http://www.locumusa.com International Journal 193 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 2006 (<$100M)

Drug Generic Patent Patent Exclusivity Patent Earliest 1998

ON-OFF Name Holder Expiry Expiry &
Generic 19991
Exclusivity
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Mivacron Mivacurium Glaxo 01/22/06 01/22/97 - 01/22/06 Class 2
Chloride Wellcome 4-761-418 NCE 20
Omniflox Ternafloxaci Abbott 01/30/06 01/30/97 U-36 01/30/06 NA
n HCl 4-730-000 NCE
Aceon Perindopril Adir 08/21/06 12/30/98 - 08/21/06 NA
Erbumine 4-508-729 NCE
Timoptic- Timolol Merck & 08/29/06 - - 08/29/06 Class 5
XE Maleate Co. 4-861-760 - 85
Videx Didanosine Bristol 08/29/06 - - 08/29/06 Class 4
Myers- 4-861-759 - 63
Squibb
Tilade Nedocromil Schering- 10/02/06 10/01/00 - 10/02/06 Class 2
Sodium Plough 4-474-787 NDF 20
Mivacron Mivacurium Glaxo //06 //06 - //06 Class
Chloride Wellcome 4-- -
Metrogel Metronidazole Galderma 06/06/06 - - Class 3
06/06/06
4-837-378 - 47
Flomax Tamulosin Boehringer 09/19/06 04/15/02 U-181 09/19/06 Class 4
HCl Ingelheim 4-868-216 NCE 64
Phoslo Calcium Braintree 09/26/06 12/10/97 - 09/26/06 Class 2
Acetate 4-870-105 ODE 17
Prohance Gadoteridol Bracco 12/05/06 11/16/06 - 12/05/06 Class 3
4-885-363 NCE 27
Mirapex Pramipexole Pharmacia 12/12/06 07/01/02 - Class 3
dihydrochloride
12/12/06
Upjohn 4-866-812 NCE 47
hydrate
USD $
Class 1 -<10m Class 2 -<25m Class 3 -<50m Class 4 -<75m Class 5 -<100m Class 6 ->100m

NOT EVERY ONE CAN GO TO

16 - 21
PHARMACEUTICAL CONFERENCES
YEAR IN - YEAR OUT
Subscribe to the
INTERNATIONAL JOURNALS
For a great overview!
See 'WHAT'S NEW' & Conference Page
www.locumusa.com/conferences

http://www.locumusa.com International Journal 194 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 2007 (<$100M)

Drug Generic Patent Patent Exclusivity Patent Earliest 1998

ON-OFF Name Holder Expiry Expiry &
Generic 19991
Exclusivity
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Dovonex Calcipotriene Bristol - 12/29/07 03/03/00 U-88 Class 5
12/29/07
Myers 4-866-048 NCE,NDF 91
Squibb
Betaseron Interferon Berlex 07/13/07 - - 07/13/07 Class 2
beta 1 4-588-585 - 17
Nasocort Triamcinolone Rhone 01/23/07 05/20/99 U-85 01/23/07 Class 4
acetonide Poulenc I-162 74
4-767-612
Rorer
Suprane Desflurane BOC Group/ 02/02/07 09/18/97 U-67 Class 4
Ohmeda
02/02/07
4-762-856 NCE 80
Precose Acarbosse Bayer 02/27/07 09/06/00 - 02/27/07 Class 3
4-904-769 NCE 35
Maxipime Cefepime Bristol 03/04/07 - - 03/04/07 Class 2
Meyers 4-406-899 - 18
Squibb
Pulmicort Budesonide Astra 03/13/07 02/14/99 - 03/13/07 Class 3
Zeneca 4-907-583 NCE 45
Omniscan Gadodiamide Sanofi 05/04/07 01/08/98 U-76 Class 3
05/04/07
inj. Winthrop 4-687-659 NCE 45
Naserel Flunisolide Roche 06/12/07 - - 06/12/07 Class 2
4-933-168 - 16
Tarka Trandolapri Knoll 06/12/07 04/26/01 - 06/12/07 Class 2
l 4-933-361 NCE 15
Nasalide Flunisolide Roche 06/12/07 - - 06/12/07 Class 2
4-933-168 - 13
Cerebyx Fosphenytoin Warner 08/05/07 08/05/03 - Class 3
Sodium
08/05/07
Lambert 4-925-860 ODE 34
Posicor Miberfradil Roche 11/10/07 06/20/02 - 11/10/07 Class 2
dihydrochlori 4-808-605 NCE 23
de
Pentasa Mesalamine Hoechst 12/25/07 - U-78 12/25/07 Class 3
Marion 4-980-173 - 38
Roussel

USD $
Class 1 -<10m Class 2 -<25m Class 3 -<50m Class 4 -<75m Class 5 -<100m Class 6 ->100m
NA = Not Applicable NC = Not confirmed in 1998 ODE = Orphan Drug Exclusivity
NCE = New Chemical Entity NP = New Product NS = New Substance
NDF = New Dosage Form NC = New Combination NE = New Salt or Ester
Note: Some Brand leader drugs products have been omitted due to non-availability of sales data which
will appear in the 2000/2001 DOP Report.
Note: Since 1996, when the average operating margin of the five major generic
companies (Alpharma, Barr, Mylan, Teva and Watson) fell to 15.5% from its historical
average of around 16-17%, the average operating margin has risen dramatically - to
almost 21% in 1997 and even higher to 22.8-23.0% in 1998. Operating margins for the
above five in 1999 and 2000 are projected to be around 23% to 24%.

http://www.locumusa.com International Journal 195 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 2008 (<$100M)
Drug Generic Patent Patent Exclusivity Patent Earliest 1998
ON-OFF Name Holder Expiry Expiry &
Generic 19991
Exclusivity
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Ifex Ifosfomide Bristol 03/03/08 - - 03/03/08 Class 4
Myers - 4-882-452 - 80
Squibb
Neurolite Technetium DuPont 11/23/08 11/23/99 U-101 11/23/08 NA
5-279-811 NCE
Semprex-D Acrivastine Glaxo- 03/26/08 03/25/97 U-93 03/26/08 Class 2
Wellcome 4-650-807 NC 11
Actinex Masoprocol Reed & 04/17/08 09/04/07 - 04/17/08
Cream Carnick 4-695-590 NCE
Hivid Zalcitabine Roche 07/02/08 06/19/97 U-65 07/02/08 Class 2
5-028-595 NCE 14
Trusopt Dorzolamide Merck & Co 04/28/08 12/09/99 - 04/28/08 Class 5
HCl 4-797-413 NCE 100+
Requip Ropinirole Smith 05/19/08 09/19/02 U-212 05/19/08 Class 2
HCl Kline 4-854-860 NCE 21
Beecham
Restoril Temazepam Novartis 07/09/08 - U-70 Class 2
Hydrochloride
07/09/08
5-326-758 - 18
Amerge Naratriptan Glaxo- 08/12/08 02/10/03 U-232 08/12/08 Class 3
Hcl Wellcome 4-997-841 NCE 36
Alkeran Melphalan Glaxo- 11/18/08 11/18/99 - 11/18/08 Class 2
Wellcome 4-997-651 ODE 15

During The New Millennium

International Journal of
Drug Development
and the
International Journal of
Generic Drugs
will be sponsoring
the Years Key Generic Conferences
THE OFFICIAL REVIEWERS FOR
PHARMACEUTICAL CONFERENCES PUBLISHED in the International Journals

http://www.locumusa.com International Journal 196 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 2009 - (<$100M)

Drug Generic Patent Patent Exclusivity Patent Earliest 1998

ON-OFF Name Holder Expiry Expiry &
Generic 19991
Exclusivity
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Permax Pergolide Athena 10/19/09 - - Class 3
Neuroscience
10/19/09
Mesylate 5-114-948 - 40
Ultiva Remifen- Glaxo - 02/15/09 07/12/01 - 02/15/09 Class 1
tanil Wellcome 5-019-583 NCE 5
HCl
Baycol Cerivastin Bayer 01/17/09 06/26/02 - 01/17/09 Class 3
Sodium 5-006-530 NCE 29
Tricor Fenofibrate Fournier 01/19/09 - - 01/19/09 Class 2
(micronised) Research 4-895-726 - 15
Mepron Atovaquone Glaxo - 08/15/09 01/05/06 - 08/15/09 Class 2
Wellcome 4-981-874 ODE 23
Astelin Azelastine Carter 11/17/09 11/01/01 U-207 11/17/09 Class 3
HCl Wallace 5-164-194 NCE 38
Migranal Dihydro Novartis 12/08/09 12/08/00 - 12/08/09 Class 2
ergotamine 5-169-849 NDF 18
Mesylate
Arimidex Anastrozole Astra 12/27/09 12/27/00 - 12/27/09 Class 3
Zeneca 4-935-437 NCE 45
Andro- Testosterone Smith 10/06/09 - - 10/06/09 Class 2
derm Kline 5-152-997 - 21
Beecham

Year of Expiration - 2010 - (<$100M)

Drug ON- Generic Patent Patent Exclusivity Patent Earliest 1998
OFF Holder &
Name Expiry Expiry Exclusivity Generic 19991
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Kadian Morphine Faulding 04/13/10 07/03/99 - 04/13/10 Class 1
Sulphate 5-202-128 NDF 4
Feridex Ferumoxides Advanced 09/28/10 08/30/01 - 09/28/10 Class 1
Magnetics 5-248-492 NCE 1
Iodipine Apraclonidine Alcon 05/18/10 - U-120,U-15 Class 2
Hydrochloride
05/18/10
4-517-199 - 19
Hycamtin Topotecan Smith Kline 05/28/10 05/28/01 - 05/28/10 Class 4
HCl Beecham 5-004-758 NCE 78
Climara Estradiol Berlex 06/29/10 03/05/02 - 06/29/10 Class 4
5-223-261 I-254 72
Invirase Saquinavir Roche 11/19/10 12/06/00 - 11/19/10 Class 4
Mesylate 5-196-438 NCE 67
Patanol Olopatadine Alcon 12/18/10 12/18/01 - 12/18/10 Class 4
HCl 5-116-863 NCE 73

http://www.locumusa.com International Journal 197 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 2011 (<$100M)
Drug Generic Patent Patent Exclusivity Patent Earliest 1998
ON-OFF Name Holder Expiry Expiry &
Generic 19991
Exclusivity
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Synarel Naferlin Roche 06/11/11 - - 06/11/11 Class 1
Acetate 4-234-571 - 10
Visipaque Iodixanol Nycomed 09/20/11 03/22/01 - 09/20/11 Class 3
270 5-349-085 NCE 39
Avapro Ibesartan Sanofi/BMY 03/20/11 09/30/02 - Class 4
03/20/11
5-270-317 NCE 72
Follistim Follitropin Organon 03/20/11 09/29/00 - 03/20/11 Class 4
Alfa/beta NP 56
Astelin Azelastine Wallace 10/16/11 - U-207 10/16/11 Class 3
Hcl 5-164-194 - 37
Viramune Nevirapine Boehringer 11/22/11 06/21/01 U-167 11/22/11 Class 5
Ingleheim 5-366-972 NCE

NA = Not Applicable NC = Not confirmed in 1998 ODE = Orphan Drug Exclusivity

NCE = New Chemical Entity NP = New Product NS = New Substance
NDF = New Dosage Form NC = New Combination NE = New Salt or Ester
USD $
Class 1 -<10m Class 2 -<25m Class 3 -<50m Class 4 -<75m Class 5 -<100m Class 6 ->100m

For the New Millennium

International Journal of
Drug Development
and the

International Journal of
Generic Drugs
WORLD LEADERS in
GENERIC DRUG CONFERENCES
THE OFFICIAL REVIEWERS FOR
PHARMACEUTICAL CONFERENCES PUBLISHED in LIG's International Journals

http://www.locumusa.com International Journal 198 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 2012 (<$100M)

Drug Generic Patent Patent Exclusivity Patent Earliest 1998

ON-OFF Name Holder Expiry Expiry &
Generic 19991
Exclusivity
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Photofrin Porfimer QLT 08/01/12 12/27/00 U-128 08/01/12 Class 1
Sodium Photo NCE 4
Therapeu-tics
5-438-071
Imodium Loperamide Johnson & 05/21/12 06/26/00 - 05/21/12 Class 2
Advanced HCl Johnson 5-716-641 NC 15
Gabitril Tiagabine Abbott 03/24/12 09/30/02 - 03/24/12 Class 2
HCl - NCE 14
Motrin Ibuprofen Johnson & 06/20/12 - - 06/20/12 Class 2
Johnson 5-374- - 22
659*PED
Tasmar Tolcapone Roche 12/19/12 01/29/03 - 12/19/12 Class 3
5-476-875 NCE 31
Fortovase Saquinavir Roche 11/19/12 12/06/00 - 11/19/12 Class 4
5-196-438 NCE 78
Diovan Valsartan- Novartis 03/21/12 12/23/01 U-3 03/21/12 Class 2
HCT hydrochlorthiazide NCE 20
5-399-578
Nimbex Cisatracurium Glaxo 09/26/12 12/15/98 U-127 09/26/12 Class 3
Besylate Wellcome 5-453-510 NE 36

Year of Expiration - 2013 (<$100M)

Drug Generic Patent Patent Exclusivity Patent Earliest 1998
ON-OFF Name Holder Expiry Expiry &
Generic 19991
Marketer Exclusivity
Patent
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Cerezyme Imiglucerase Genzyme 08/28/13 05/23/01 U-252 08/28/13 Class 2
5-549-892 NCE,ODE 16
Humalog Insulin Eli Lilly 05/07/13 06/14/01 U-111 05/07/13 Class 4
Lispro 5-514-646 NCE 63
Raxar Grepafloxaci Glaxo- 10/08/13 11/06/02 - 10/08/13 Class 2
n Wellcome 5-563-183 NCE 15
HCl
Crinone Progesterone AHP/Wyeth- 09/15/13 07/13/00 - Class 2
Ayerst
09/15/13
5-543-150 NP 19
Propecia Finasteride Merck & 10/15/13 12/19/00 U-236 10/15/13 Class 3
Co 5-547-957 NP 36
USD $
Class 1 -<10m Class 2 -<25m Class 3 -<50m Class 4 -<75m Class 5 -<100m Class 6 ->100m

Note: The generic share of total prescription has leveled in recent years with the first
decline showing in 1998 (41.5%) for the first time in many years (Highest was 42.2% in
1997) while the generic share of dollar sales is only 8.75% (Declined over the past 3
years from a high of 11.4% in 1995.)

http://www.locumusa.com International Journal 199 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim
 International Journal of Generic Drugs

D r u g s Off-Patent R e p o r t s
Year of Expiration - 2013 (<$100M)

Drug Generic Patent Patent Exclusivity Patent Earliest 1998

ON-OFF Name Holder Expiry Expiry &
Generic 19991
Exclusivity
Patent Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Cerezyme Imiglucerase Genzyme 08/28/13 05/23/01 U-252 08/28/13 Class 2
5-549-892 NCE,ODE 16
Humalog Insulin Eli Lilly 05/07/13 06/14/01 U-111 05/07/13 Class 4
Lispro 5-514-646 NCE 63
Raxar Grepafloxaci Glaxo- 10/08/13 11/06/02 - 10/08/13 Class 2
n Wellcome 5-563-183 NCE 15
HCl
Crinone Progesterone AHP/Wyeth- 09/15/13 07/13/00 - Class 2
Ayerst
09/15/13
5-543-150 NP 19
Propecia Finasteride Merck & 10/15/13 12/19/00 U-236 10/15/13 Class 3
Co 5-547-957 NP 36

Year of Expiration - 2014 (<$100M)

Drug Generic Patent Patent Exclusivity Patent Earliest 1998
ON-OFF Name Holder Expiry Expiry &
Generic 19991
Marketer Exclusivity
Patent
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Sustiva Efavirenz DuPont 09/02/14 09/17/03 - 09/02/14 Class 2
Pharm. 5-663-169 NCE 18
Mavik Trandolapril BASF 04/28/15 04/26/01 - 04/28/15 Class 2
5-744-496 NCE 18
Gonal-F Follitropin Serona 06/16/15 06/16/15 - Class 4
Laboratories
06/16/15
Alpha/beta 5-767-251 - 85
Adenoscan Adenosine Jujisawa 03/24/15 05/18/98 U-221 03/24/15 Class 3
5-731-296 I-126 55
Proventil- Albuterol Schering- 06/16/15 09/23/01 - 06/16/15 Class 4
HFA sulfate Plough 5-766-573 I-235 69

Proventil- Albuterol Schering- 06/16/15 09/23/01 - 06/16/15 Class 4

HFA sulfate Plough 5-766-573 I-235 69

Aggrastat Tibofiban Merck & 10/23/16 05/14/03 - 10/23/16 Class 2

HCl Co. 5-733-919 NCE 18

Extended Patent Protection:

One of the provisions in GATT (July 8,1995) provided extra patent protection by
extending the patent life to 20 years from the date of filing with the FDA agency.
Previously product patent protection had been 17 years from patent approval. Patents
generally take no longer than 2 to 3 years to get through the US Patent Office (PTO)
while the average new drug patent approval is about 18 months. n

http://www.locumusa.com International Journal 200 of Generic Drugs e-* info@locumusa.com

ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim