ANDA Approvals

Summer 2017

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
4/3/2017 Nasonex Mometasone Furoate Merck Sharp Dohme Amneal
4/3/2017 Tazorac / Avage Tazarotene Allergan Taro
4/4/2017 Ativan Lorazepam West-Ward Pharms Sagent Agila
4/4/2017 Celebrex Celecoxib GD Searle Jubilant Generics
4/6/2017 Wellbutrin XL Bupropion Hydrochloride Valeant Lupin
4/7/2017 Avodart Dutasteride GlaxoSmithKline Marksans Pharma
4/7/2017 Seasonique Simpesse Teva Aurobindo
4/7/2017 Entocort EC Budesonide Perrigo Appco Pharma
4/10/2017 Naftin Naftifine Hydrochloride Sebela Ireland Tolmar
4/12/2017 Wellbutrin XL Bupropion Hydrochloride Valeant Sciegen Pharms
4/14/2017 Perphenazine Perphenazine Sandoz Mylan
4/18/2017 Temodar Temozolomide Merck Sharp Dohme Watson / Teva
4/18/2017 Integrilin Eptifibatide Schering Akorn
4/18/2017 Singulair Montelukast Sodium Merck CSPC Ouyi Pharm
4/18/2017 Amidate Etomidate Hospira Gland Pharma
4/19/2017 Dexilant Dexlansoprazole Takeda Par
4/20/2017 Felbatol Felbamate Mylan Taro
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Teva
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Torrent
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Alembic
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Aurobindo
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo MacLeods
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Zydus
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Jubilant Generics
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Alkem Labs
4/24/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Accord Healthcare
4/24/2017 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Daiichi Sankyo Teva
4/24/2017 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Daiichi Sankyo Alembic
4/24/2017 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Daiichi Sankyo Aurobindo
4/24/2017 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Daiichi Sankyo Prinston
4/24/2017 Singulair Montelukast Sodium Merck CSPC Ouyi Pharm
4/25/2017 Rayos Prednisone Horizon Pharma Actavis Labs
4/26/2017 Vytorin Ezetimibe / Simvastatin Merck Sharp & Dohme Dr. Reddys
4/26/2017 Vytorin Ezetimibe / Simvastatin Merck Sharp & Dohme Impax
4/26/2017 Vytorin Ezetimibe / Simvastatin Merck Sharp & Dohme Watson
4/26/2017 Precedex Dexmedetomidine Hydrochloride Hospira West-Ward Pharms
4/26/2017 Singulair Montelukast Sodium Merck Perrigo
4/26/2017 Temodar Temozolomide Merck Sharp Dohme Deva Holding
4/26/2017 Bloxiverz Neostigmine Methylsulfate Eclat Pharms Par Sterile Products
4/27/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Lupin
4/27/2017 Cortef Hydrocortisone Pharmacia and Upjohn PII
4/27/2017 Sabril Vigabatrin Lundbeck Pharms Par Pharm
4/28/2017 Ativan Lorazepam West-Ward Pharms Sagent Agila
4/28/2017 Ortho-Novum 1/35-28 Norethindrone / Ethinyl Estradiol Janssen Accord Healthcare
4/28/2017 Clobex Clobetasol Propionate Galderma Labs Akorn
4/28/2017 Dymista Azelastine Hydrochloride / Fluticasone Propionate Mylan Apotex
4/28/2017 Mepron Atovaquone GlaxoSmithKline Paddock
5/2/2017 Ultracet Tramadol Hydrochloride / Acetaminophen Janssen MacLeods
5/3/2017 Benicar HCT Olmesartan Medoxomil / Hydrochlorothiazide Daiichi Sankyo Torrent
5/3/2017 Micardis Telmisartan Boehringer Ingelheim Prinston
5/4/2017 Entocort EC Budesonide Perrigo Zydus
5/4/2017 Daypro Oxaprozin GD Searle Amneal
5/5/2017 Combivir Lamivudine / Zidovudine ViiV Healthcare Aurobindo Pharma
5/5/2017 Elestat Epinastine Hydrohcloride Allergan Akorn
5/5/2017 Avelox in Sodium Chloride 0.8% in Plastic Container Moxifloxacin Hydrochloride in Sodium Chloride 0.8% in Plastic Container Bayer Healthcare Mylan
5/5/2017 Calan SR Verapamil Hydrochloride Pfizer Cadila Pharms
5/5/2017 Motrin IB (OTC) Ibuprofen (OTC) Johnson and Johnson Aiping Pharm
5/8/2017 Ammonul Sodium Phenylacetate / Sodium Benzoate Medicis Maia Pharms
5/9/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Par
5/9/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Accord Healthcare
5/9/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Intellipharmaceutics
5/9/2017 Clolar Clofarabine Genzyme Abon Pharms
5/9/2017 Metronidazole in Plastic Container / Metro I.V. in Plastic Container / Flagyl I.V. RTU in Plastic Container Metronidazole in Plastic Container Hospira / B Braun / Baxter Healthcare Mylan
5/9/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Pharmadax
5/11/2017 Baraclude Entecavir Bristol Myers Squibb Sandoz
5/11/2017 Ritalin Methylpenidate Hydrochloride Novartis Abhai
5/11/2017 Soma Carisoprodol Mylan Nostrum Labs
5/12/2017 Precedex Dexmedetomidine Hydrochloride Hospira Luitpold Pharms
5/12/2017 Oxaliplatin / Eloxatin Oxaliplatin Teva  / Sanofi Aventis Luitpold Pharms
5/12/2017 Haldol Haloperidol Decanoate Janssen Gland Pharma
5/12/2017 Glucotrol XL Glipizide Pfizer Aurobindo
5/12/2017 Trilipix Fenofibric Acid AbbVie Alembic
5/15/2017 Azilect Rasagiline Mesylate Teva Mylan
5/15/2017 Zutripro Hydrocodone Bitartrate / Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride Cypress Pharm Bio-Pharm
5/15/2017 Azor Amlodipine / Olmesartan Medoxomil Daiichi Sankyo Aurobindo
5/15/2017 Pennsaid Diclofenac Sodium Horizon Pharma Actavis
5/15/2017 Macrobid Nitrofurantoin (Monohydrate/ Macrocrystals) Alvogen Malta Amneal
5/15/2017 Azor Amlodipine / Olmesartan Medoxomil Daiichi Sankyo Jubilant Generics
5/15/2017 Doxil (Liposomal) Doxorubicin Hydrochloride (Liposomal) Janssen Dr. Reddys
5/17/2017 Nexium IV Esomeprazole Sodium AstraZeneca Mylan Labs
5/17/2017 Seroquel XR Quetiapine Fumarate AstraZeneca Lupin
5/17/2017 Lexapro Escitalopram Oxalate Forest Labs Amneal
5/17/2017 Tamiflu Oseltamivir Phosphate Roche Amneal
5/18/2017 Cymbalta Duloxetine Hydrochloride Lilly Prinston
5/22/2017 Argatroban in Sodium Chloride Argatroban in Sodium Chloride Sandoz Gland Pharma
5/23/2017 Namenda Memantine Hydrochloride Forest Labs Strides Pharma
5/23/2017 Abilify Aripiprazole Otsuka Orchid Healthcare
5/23/2017 Zestoretic Lisinopril / Hydroclorothiazide Alvogen Malta Invagen Pharms
5/23/2017 Gemcitabine Hydrochloride Gemcitabine Hydrochloride Hospira Apotex
5/24/2017 Luxiq Betamethasone Valerate Mylan RiconPharma
5/24/2017 Luxiq Betamethasone Valerate Mylan Taro Pharm
5/24/2017 Hectorol Doxercalciferol Genzyme Amneal
5/24/2017 Hectorol Doxercalciferol Genzyme Amneal
5/25/2017 Benicar Olmesartan Medoxomil Daiichi Sankyo Glenmark
5/25/2017 Sodium Chloride 0.9% in Plastic Container Sodium Chloride 0.9% in Plastic Container B Braun / Baxter Healthcare / Hospira / ICU Medical Inc Laboratorios Grifols
5/26/2017 Angiomax Bivalirudin The Medicines Co Dr Reddys
5/26/2017 Camptosar Irinotecan Hydrochloride Pfizer Ingenus Pharms
5/26/2017 DDAVP Desmopressin Acetate Ferring Heritage Pharma
5/30/2017 Strattera Atomoxetine Hydrochloride Eli Lilly Apotex
5/30/2017 Strattera Atoxoxetine Hydrochloride Eli Lilly Aurobindo Pharma
5/30/2017 Strattera Atomoxetine Hydrochloride Eli Lilly Glenmark
5/30/2017 Strattera Atoxoxetine Hydrochloride Eli Lilly Teva
5/30/2017 Zyprexa Zydis Olanzapine Eli Lilly Ajanta Pharma
5/30/2017 Motrin IB (OTC) Ibuprofen (OTC) Johnson and Johnson Strides Pharma
5/30/2017 Felbatol Felbamate Mylan Zydus
5/31/2017 Dacogen Decitabine Otsuka Pharm Pharmascience
6/1/2017 Remeron Soltab Mirtazapine Organon USA Zydus
6/1/2017 Levaquin Levofloxacin Janssen Zydus
6/2/20017 Corgard Nadolol US Worldmeds Amneal
6/5/2017 Lialda Mesalamine Shire Zydus
6/5/2017 Comtan Entacapone Orion Pharma MacLeods
6/8/2017 Avalide Irbesartan / Hydrochlorothiazide Sanofi Aventis West-Ward Pharms
6/8/2017 Cardizem CD Diltiazem Hydrochloride Valeant Sun Pharm
6/9/2017 Vituz Hydrocodone Bitartrate / Chlorpheniramine Maleate Cypress Pharm Acella Pharms
6/12/2017 Roxicodone Oxycodone Hydrochloride Mallinckrodt Novel Labs
6/12/2017 Zetia Ezetimibe Merck Sharp & Dohme Zydus
6/12/2017 Zetia Ezetimibe Merck Sharp & Dohme OHM Labs
6/12/2017 Zetia Ezetimibe Merck Sharp & Dohme Apotex
6/12/2017 Zetia Ezetimibe Merck Sharp & Dohme Amneal
6/12/2017 Sporanox Itraconazole Janssen Alkem Labs
6/13/2017 Renvela Sevelamer Carbonate Genzyme Aurobindo
6/13/2017 Rocaltrol Calcitriol Validus Pharms Amneal
6/14/2017 Acticlate Doxycycline Hyclate Aqua Pharms Mayne Pharma
6/15/2017 Skelaxin Metaxalone King Pharms Actavis Labs
6/15/2017 Loestrin 24 FE Aurovela 24 FE Apil Aurobindo
6/15/2017 Loestrin FE 1.5/30 Aurovela FE 1.5/30 Apil Aurobindo
6/16/2017 Niaspan Niacin AbbVie Lannett
6/16/2017 Zyprexa Olanzapine Lilly Hikma
6/16/2017 Nimbex Cisatracurium Besylate Preservative Free AbbVie Accord Healthcare
6/16/2017 Felbatol Felbamate Mylan Taro Pharm
6/16/2017 Relpax Eletriptan Hydrobromide Pfizer Zydus
6/19/2017 Dantrium Dantrolene Sodium Par Hikma
6/20/2017 Feldene Piroxicam Pfizer PII
6/20/2017 Brisdelle Paroxetine Mesylate Sebela Ireland Actavis Labs
6/20/2017 Flagyl Metronidazole GD Searle Orit Labs
6/20/2017 Atacand Candesartan Cilexetil AstraZeneca Alembic Pharms
6/21/2017 Gleevec Imatinib Mesylate Novartis Mylan
6/22/2017 Morphine Sulfate Morphine Sulfate West-Ward Pharms Rhodes Pharms
6/22/2017 Robaxin Methocarbamol West-Ward Pharms Luitpold Pharms
6/23/2017 Baraclude Entecavir Bristol Myers Squibb Zydus
6/23/2017 Vidaza Azacitidine Celgene Natco Pharma
6/26/2017 Ditropan XL Oxybutynin Chloride Janssen Zydus
6/27/2017 Benzaclin Clindamycin Phosphate / Benzoyl Peroxide Valeant Tolmar
6/27/2017 Cyklokapron Tranexamic Acid Pharmacia and Upjohn Micro Labs
6/27/2017 Dexedrine Dextroamphetamine Sulfate Amedra Pharms Nesher Pharms
6/27/2017 Children's Motrin (OTC) Ibuprofen (OTC) Johnson and Johnson Taro
6/28/2017 Tobrex Tobramycin Novartis Somerset Theraps
6/28/2017 Cleocin  Clindamycin Phosphate in 5% Dextrose in Plastic Container Pharmacia and Upjohn Celerity Pharms
6/30/2017 Zomig Zolmitriptan IPR Appco Pharma
6/30/2017 Wellbutrin XL Bupropion Hydrochloride Valeant Anbison Lab
6/30/2017 Wellbutrin XL Bupropion Hydrochloride Valeant Jubilant Generics
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