NDA PATENT EXPIRY

No. DRUG NAME BRAND NAME APPLICANT RELATED PATENTS DATE

Sept 2, 2014, Jul 23,

1 Adefovir Dipivoxil HEPSERA GILEAD 5663159, 6451340 2018

BRISTOL
Atazanavir MYERS June 20, 2017, Dec
2 Sulfate REYATAZ SQUIBB 5849911, 6087383 21, 2018

Atovaquone and Nov 25, 2013 , Nov

Proguanil MALARONE GLAXOSMITH 5998449, 6166046, 25, 2013 , Nov 25,
3 Hydrochloride PEDIATRIC KLINE 6291488 2013

Sept 21, 2012, May

6403649, 7351404, 25, 2024 , Jan 21,
4 Bimatoprost LATISSE ALLERGAN 7388029 2022

Dec 23, 2018 , Dec

PULMICORT 6598603, 6899099, 23, 2018 , Nov 11,
5 Budesonide RESPULES ASTRAZENECA 7524834 2018

Calcipotriene and Jun 9, 2015 , Jan 27,

Betamethasone 5763426, 6753013, 2020 , Jan 27, 2020 ,
6 Dipropionate TACLONEX LEO PHARM 6753013, RE39706 Jun 9, 2015

Apr 11, 2017 , Jul 15,

7 Clarithromycin BIAXIN XL ABBOTT 6010718, 6551616 2017

Clobetasol STIEFEL LABS Sep 8, 2019, Sep 8,

8 Propionate OLUX E INC 6730288, 7029659 2019

Jun 10, 2014, Apr 29,

2014 , Dec 2, 2014,
Apr 29, 2014, Apr 29,
5607669, 5679717, 2014 , Apr 29,
5693675, 5917007, 2014 ,Apr 29, 2014 ,
5919832, 6066678, Apr 29, 2014 , Apr
Colesevelam DAIICHI 6433026, 6784254, 29, 2014, Apr 17,
9 Hydrochloride WELCHOL SANKYO 7101960, 7229613, 2022

Dec 1, 2015 , Dec 1,

2015 , Dec 1, 2015 ,
5843946 , 5843946 , Jun 26, 2016 , Aug
5843946 , 6037157 , 13, 2014 , Aug 25,
6248775 , 6335460 , 2012 , Aug 25,
6335460 , 6335460 , 2012 , Aug 25, 2012 ,
Darunavir 6703403 , 7470506 , Jun 26, 2016 , Jun 23,
10 Ethanolate PREZISTA TIBOTEC 7700645 2019 , Dec 26, 2026
 Jun 28, 2020, Jun 28,
BRISTOL 6596746, 6596746, 2020, Apr 13, 2020,
MYERS 7125875, 7125875, Apr 13, 2020, Apr 28,
11 Dasatinib SPRYCEL SQUIBB 7153856, 7491725 2020, Mar 28, 2026

Jun 15, 2020, Jun 15,

2020, Jun 15, 2020,
6462058, 6462058, Jun 15, 2020 , Jun 15,
6462058, 6664276, 2020, Jun 15, 2020,
6664276, 6664276, Jun 15, 2020, Jun 15,
6939971, 6939971, 2020 , Jun 15, 2020,
TAKEDA 6939971, 7285668, Jun 15, 2020, Aug 2,
12 Dexlansoprazole DEXILANT PHARMS 7790755 2026,

Dec 4, 2015, Dec 4,

2015, Nov 1, 2019,
5837284, 5908850, Dec 4, 2015, Dec 4,
Dexmethylphenid 6228398, 6355656, 2015, Dec 4, 2015,
ate 6528530, 6635284, Nov 1, 2019, Dec 4,
13 Hydrochloride FOCALIN XR NOVARTIS 6730325, 7431944 2015

Donepezil 4895841, 7727548, Nov 25, 2010, Jun 23,

14 Hydrochloride ARICEPT ODT EISAI INC 7727552 2022, Mar 26, 2018

Mar 26, 2013 , Jan 9,

2015 , Jan 9, 2015 ,
5502047, 5585115, Jan 9, 2015 , Jan 9,
5725884, 5866166, 2015 , Jan 9, 2015 ,
Doxepin 5948438, 6103219, Feb 17, 2020 , Jan 9,
15 Hydrochloride SILENOR SOMAXON 6211229, 6217909 2015

Feb 11, 2014, Jul 18,

16 Doxercalciferol HECTOROL GENZYME 5602116, 6903083 2021

Dutasteride and Nov 20, 2015 , Sep

Tamsulosin GLAXOSMITH 5565467, 5846976 , 17, 2013 , Sep 17,
17 Hydrochloride JALYN KLINE 5998427 2013
 Eletriptan PFIZER Dec 26, 2016, Aug
18 Hydrobromide RELPAX IRELAND 5545644, 6110940 29, 2017

BRISTOL
MYERS
19 Entecavir BARACLUDE SQUIBB 5206244 Feb 21, 2015

Eprosartan
20 Mesylate TEVETEN ABBOTT 5656650 Aug 12, 2014

Dec 12, 2012, Aug 12,

5474783, 5656286, 2014, Dec 12, 2012,
21 Estradiol VIVELLE-DOT NOVARTIS 5958446, 6024976 Jan 7, 2014

Oct 25, 2016, Oct 25,

Estradiol Valerate BAYER 6133251, 6133251, 2016, Oct 25, 2016,
22 and Dienogest NATAZIA HLTHCARE 6133251, 6884793 Oct 25, 2016

SHIONOGI
23 Fenofibrate FENOGLIDE PHARMA 7658944 Dec 9, 2024

Nov 26, 2013, Mar

14, 2010, May 11,
5578610, 6037353, 2012, May 11, 2012,
Fexofenadine SANOFI 6187791, 6399632, May 18, 2014, Nov
24 Hydrochloride ALLEGRA AVENTIS US 7138524 18, 2014
 Dec 5, 2015, Aug 20,
25 Gatifloxacin ZYMAXID ALLERGAN 5880283, 6333045, 2019

Hydrocortisone LOCOID TRIAX

26 Butyrate LIPOCREAM PHARMS LLC 5635497 Jun 3, 2014

Hydromorphone MALLINCKRO Jul 7 , 2014, Jul 7 ,

27 Hydrochloride EXALGO DT INC 5702725, 5914131 2014

Nov 14, 2020, Mar

28 Ibupofen Lysine NEOPROFEN LUNDBECK INC6342530, 6344479 20, 2021

Oct 4, 2019, Aug 28,

2018, Jul 24, 2016,
5635517, 6045501, Oct 23, 2020, Jul 24,
6281230, 6315720 , 2016, Aug 28, 2018,
6555554, 6561976, Oct 23, 2020, Oct 23,
6561977, 6755784 , 2020, Aug 28, 2018,
6908432, 7119106, Jul 24, 2016, Apr 11,
7189740, 7465800, 2023, Apr 22, 2026,
29 Lenalidomide REVLIMID CELGENE 7855217 Nov 24, 2024

Methylphenidate MALLINCKRO
30 Hydrochloride METHYLIN DT 7691880 Oct 07, 2024

Metoclopramide
31 Hydrochloride METOZOLV ODT SALIX PHARMS6413549 Jul 11, 2017
 Minocycline Feb 19, 2018, Nov
32 Hydrochloride SOLODYN MEDICIS 5908838, 7790705 20, 2025

Feb 3, 2015 , May 4,

5714504, 5900424, 2016, May 25, 2018,
Naproxen and 6369085, 6875872, May 27, 2014, Feb
Esomeprazole ASTRAZENEC 6926907, 7411070, 28, 2023, May 25,
33 Magnesium VIMOVO A LP 7745466 2018 , Oct 13, 2018

May 27, 2017, Sep

20, 2013, Sep 20,
6080428, 6129930, 2013, Mar 15, 2018,
6406715, 6469035, Sep 20, 2013, Sep 20,
Niacin and 6676967, 6746691, 2013 , Sep 20, 2013,
34 Simvastatin SIMCOR ABBOTT 6818229, 7011848 Sep 20, 2013

Omeprazole and Jul 15 , 2016, Jul 15 ,

Sodium 6489346, 6645988, 2016, Jul 15 , 2016,
35 Bicarbonate Zegerid OTC SCHERING PL 6699885, 7399772 Jul 15 , 2016

Oseltamivir 5763483, 5866601, Dec 27, 2016 , Feb 2,

36 Phosphate TAMIFLU ROCHE 5952375, 2016 , Feb 2, 2016

Apr 16, 2013, Jun 24,

2017, Mar 30, 2025,
5508042, 6488963, Mar 30, 2025, Mar
Oxycodone PURDUE 7674799, 7674800, 30, 2025, Apr 19,
37 Hydrochloride OXYCONTIN PHARMA LP 7683072, 7776314 2025

Pramipexole BOEHRINGER Oct 8, 2010, Apr 26,

38 Dihydrochloride MIRAPEX ER INGELHEIM 4886812, 7695734 2028
 Prednisolone
Sodium SHIONOGI 6024981, 6221392, Apr 9, 2018, Apr 9,
39 Phosphate ORAPRED ODT PHARMA 6740341 2018, Nov 24, 2019

Oct 8, 2013, Dec 30,

5563175, 6001876, 2018, Dec 30, 2018,
6001876, 6197819, Dec 30, 2018, Dec 30,
40 Pregablin LYRICA PFIZER RE41920 2018

May 27, 2019, May

27, 2019, May 27,
2019, May 27, 2019,
6303607, 6369062, May 27, 2019, May
6479496, 6503911, 27, 2019, May 27,
6525057, 6562826, 2019, May 27, 2019,
6617328, 6620814, May 27, 2019, May
41 Ranolazine RANEXA GILEAD 6852724, 6864258 27, 2019

Feb 7 , 2012, Feb 7 ,

2017, Feb 7 , 2012,
5387612, 5453446, Jul 2 , 2013, Feb 7 ,
5457133, 5532415, 2012, Sep 18 , 2016,
Rasagiline 5786390, 6126968, Dec 5 , 2026, Aug 27 ,
42 Mesylate AZILECT TEVA 7572834, 7815942 2027

Jul 7, 2013, Jan 25 ,

WYETH 5100899, 5145684, 2011, Apr 4 , 2012,
43 Sirolimus RAPAMUNE PHARMS INC 5403833, 5989591 Mar 11 , 2018

Sodium Sulfate,
Potassium Sulfate
and Magnesium SUPREP BOWEL BRAINTREE
44 Sulfate PREP KIT LABS 6946149 Apr, 30, 2022

Jul 4, 2020, Jul 4,

2020, Mar 7, 2024 ,
6780889, 7262219, Jun 16, 2024 , Jun 16,
7668730, 7765106, 2024, Dec 22, 2019,
7765107, 7851506, Dec 22, 2019, Dec 17,
45 Sodium Oxybate XYREM JAZZ 7851506, 7895059 2022
 Apr 24 , 2017, Jul 26 ,
2022, Feb 2 , 2019,
Feb 2 , 2019, Feb 2 ,
6303661, 6699871, 2019, Feb 2 , 2019,
6890898, 6890898, Feb 2 , 2019, Feb 2 ,
6890898, 7078381, 2019, Feb 2 , 2019,
7078381, 7078381, Jul 26 , 2022, Jul 26 ,
7078381, 7125873, 2022, Jul 26 , 2022,
Sitagliptin 7125873, 7125873, Jul 26 , 2022, Apr 11,
46 Phosphate JANUVIA MERCK CO INC7125873, 7326708 2026

Apr 24 , 2017, Jul 26 ,

2022, Feb 2 , 2019,
6303661, 6699871, Feb 2 , 2019, Feb 2 ,
6890898, 6890898, 2019, Feb 2 , 2019,
Sitagliptin 6890898, 7078381, Feb 2 , 2019, Feb 2 ,
Phosphate and 7078381, 7078381, 2019, Jul 26 , 2022,
Metformin 7125873, 7125873, Jul 26 , 2022, Jul 26 ,
47 Hydrochloride JANUMET MERCK 7125873, 7326708 2022, Apr 11 , 2026

6573293, 7125905, Feb 15, 2021, Feb 15,

48 Sunitinib Malate SUTENT CPPI CV 7211600 2021, Dec 22, 2020

Jan 31, 2012, Sep 9,

49 Tacrolimus PROTOPIC ASTELLAS 5385907, 5665727 2014

Jul 25 , 2017, Jul 25 ,

2017, Jul 25 , 2017,
Jul 25 , 2017, Jul 25 ,
5922695, 5922695, 2017, Jul 25 , 2017,
5922695, 5922695, Jul 25 , 2017, Jul 25 ,
5935946, 5935946, 2017, Jul 25 , 2017,
5935946, 5935946, Jul 25 , 2017, Jul 25 ,
5977089, 5977089, 2017, Jul 25 , 2017,
Tenofovir 5977089, 5977089, Jul 25 , 2017, Jul 25,
Disoproxil 6043230, 6043230, 2017, Jul 25 , 2017,
50 Fumarate VIREAD GILEAD 6043230, 6043230 Jul 25 , 2017
 Trazodone Jun 29, 2020, Mar 27,
51 Hydrochloride OLEPTRO LABOPHARM 6607748, 7829120 2027

ORTHO
DERMATOLO
52 Tretinoin RETIN-A MICRO GICS 5955109 Sept 21, 2016

Varenicline 6410550, 6890927, May 10, 2020, May 6,

53 Tartrate CHANTIX PFIZER INC 7265119 2022, Aug 3, 2022

Nov 15, 2011, May

5364938, 5567817, 24, 2016, Jan 25,
54 Voriconazole VFEND PFIZER 5773443 2011

Zolpidem MEDA
55 Tartrate EDLUAR PHARMS 6761910 Sept 24, 2019