ANDA Approvals

Fourth Quarter

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.

Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
10/01/2020 Diamox Acetazolamide Teva Micro Labs
10/01/2020 Proamatine Midodrine HCl Takeda Xiromed
10/02/2020 Nexium Esomeprazole Magnesium AstraZeneca CSPC Ouyi
10/02/2020 Anafril Clomipramine HCl SpecGx Ajanta Pharma
10/06/2020 Acticlate Doxycycline Hyclate Almirall Mylan
10/06/2020 Tecfidera Dimethyl Fumarate Biogen Lupin
10/06/2020 Tecfidera Dimethyl Fumarate Biogen Glenmark
10/06/2020 Methylin ER Methylphenidate HCl SpecGx Alkem Labs
10/06/2020 Monurol Fosfomycin Tromethamine Zambon Xiromed
10/06/2020 Akovaz Ephedrine Sulfate Exela Dr Reddy's Labs
10/06/2020 Firazyr Icatibant Acetate Shire Dr Reddy's Labs
10/06/2020 Lomotil Diphenoxylate HCl / Atropine Sulfate Pfizer Specgx
10/06/2020 Ultravate Halobetasol Propionate Sun Pharma Quagen
10/07/2020 Sensipar Cinacalcet HCl Amgen Hetero Labs
10/07/2020 Finacea Azelaic Acid Leo Teva
10/07/2020 Diamox Acetazolamide Teva Mankind
10/08/2020 Proventil Albuterol Sulfate Schering Plough Eywa
10/08/2020 Phernagen with Codeine Promethazine HCl / Codeine Phosphate ANI Pharma Quagen
10/09/2020 Nordette-28 Levonorgestrel / Ethinyl Estradiol Teva Naari Pte
10/09/2020 Lioresal Baclofen Novartis Innogenix
10/13/2020 Ultiva Remifentanil HCl Mylan Navinta
10/13/2020 Kerydin Tavaborole Anacor Encube
10/13/2020 Kerydin Tavaborole Anacor Perrigo
10/14/2020 Gilenya Fingolimod HCl Novartis Zydus
10/14/2020 Tecfidera Dimethyl Fumarate Biogen Twi
10/15/2020 Isoptin Verapamil HCl Mt Adams Tech Zydus
10/15/2020 Symmetrel Amantadine HCl Endo Alembic Pharms
10/15/2020 Isoptin Verapamil HCl Mt Adams Tech Gland Pharma
10/16/2020 Rapamune Sirolimus Pfizer Glenmark Pharms
10/16/2020 Sinequan Doxepin HCl Pfizer Epic Pharma
10/16/2020 Actigall Ursodiol Allergan Zydus
10/19/2020 Vesicare Solifenacin Succinate Astellas Zydus
10/19/2020 Levo T Levothyroxine Sodium Cediprof Accord Healthcare
10/19/2020 Tricor (Micronized) Fenofibrate (Micronized) AbbVie Alembic Pharms
10/19/2020 Advil Ibuprofen Glaxo Yichang Humanwell
10/20/2020 Toradol Ketorolac Tromethamine Roche Aurobindo Pharma
10/20/2020 Librax Chlordiazepoxide HCl / Clidinium Bromide Bausch & Lomb ECI Pharms
10/20/2020 Halcion Triazolam Pharmacia/Upjohn Riconpharma
10/21/2020 Lomotil Diphenoxylate HCl / Atropine Sulfate Pfizer ECI Pharms
10/21/2020 Ofirmev Acetaminophen Mallinckrodt Aurobindo Pharma
10/21/2020 Emend Aprepitant Merck Torrent
10/21/2020 Kerydin Tavaborole Anacor Aleor Dermaceuticals / Alembic
10/21/2020 Skelaxin Metaxalone Pfizer Ingenus Pharms
10/21/2020 Venlafaxine HCl Venlafaxine HCl Osmotica Ascent Pharms
10/21/2020 Klor-Con Potassium Chloride Upsher-Smith Granules
10/22/2020 Lybrel Dolishale Levonorgestrel / Ethinyl Estradiol Wyeth Novast Labs
10/22/2020 Uloric Febuxostat Takeda Dr Reddys Labs
10/22/2020 Proventil Albuterol Sulfate Schering Plough Zydus Pharms
10/22/2020 Zyprexa Olanzapine Eli Lilly Aurobindo Pharma
10/22/2020 Timoptic XE Timolol Maleate Bausch & Lomb Alembic Pharms
10/22/2020 BiCNU Carmustine Emcure Dr Reddys Labs
10/22/2020 Wellcovorin Leucovorin Calcium Glaxo Leading Pharma
10/23/2020 Zetia Ezetimibe Merck Sciegen Pharms
10/23/2020 Cialis Tadalafil Eli Lilly Umedica Labs
10/23/2020 Zyflo CR Zileuton Chiesi Aizant
10/23/2020 Busulfex Busulfan Otsuka Meitheal/Nanjing King-Friend
10/23/2020 Clolar Clofarabine Genzyme Hong Kong
10/26/2020 Rozarem Ramelteon Takeda Appco
10/26/2020 Thorazine Chlorpromazine HCl Upsher-Smith Sun Pharm
10/27/2020 Magnesium Sulfate in Dextrose 5% in Plastic Container Magnesium Sulfate in Dextrose 5% in Plastic Container Hospira B Braun Medical
10/27/2020 Cialis Tadalafil Eli Lilly Yangling Buchang
10/27/2020 Nimbex Preservative Free Cisatracurium Besylate Preservative Free AbbVie Aurobindo
10/27/2020 Dibenzyline Phenoxybenzamine HCl Concordia Amneal
10/27/2020 Quelicin Succinylcholine Chloride Pfizer Nexus Pharms
10/27/2020 Evekeo Amphetamine Sulfate Arbor Alkem Labs
10/27/2020 Evekeo Amphetamine Sulfate Arbor Epic Pharma
10/27/2020 Ditropan XL Oxybutynin Chloride Johnson & Johnson Rubicon
10/28/2020 Gilenya Fingolimod HCl Novartis Accord Healthcare
10/28/2020 Tirosint Levothyroxine Sodium IBSA Teva
10/28/2020 Ritalin Methylphenidate HCl Novartis Accord Healthcare
10/29/2020 Nitropress Sodium Nitroprusside Hospira Xiromed
10/29/2020 Invega Paliperidone Janssen CSPC Ouyi
10/30/2020 Singulair Montelukast Sodium Merck Laboratorios Liomont
10/30/2020 Pomalyst Pomalidomide Celgene Breckenridge
10/30/2020 Pomalyst Pomalidomide Celgene Eugia Pharma/ Aurobindo
10/30/2020 Edecrin Ethacrynic Acid Bausch & Lomb Strides
10/30/2020 Claritin Reditabs Loratadine Bayer Tenshi
11/02/2020 Methadose Methadone HCl SpecGx Lannett
11/02/2020 Vidaza Azacitidine Celgene Meitheal
11/02/2020 Parafone Forte Chlorzoxazone Mikart Par
11/02/2020 Camptosar Irinotecan HCl Pfizer Eugia Pharma
11/03/2020 Bystolic Nebivolol HCl Allergan Hetero Labs
11/03/2020 Levophed Norepinephrine Bitartrate Hospira Fresenius Kabi
11/05/2020 Bromfed DM Brompheniramine Maleate / Pseudoephedrine HCl / Dextromethorphan Hydrobromide Wockhardt Rhodes Pharms
11/05/2020 Mycamine Micafungin Sodium Astellas Apotex
11/05/2020 Fetzima Levomilnacipran HCl Allergan Hikma
11/06/2020 Nimbex Preservative Free Cisatracurium Besylate AbbVie Sagent Pharms
11/06/2020 Nimbex Cisatracurium Besylate AbbVie Sagent Pharms
11/06/2020 Toprol-XL Metoprolol Succinate Aralez Hetero Labs
11/06/2020 Amicar Aminocaproic Acid Akorn MSN
11/09/2020 Tarceva Erlotinib HCl Genentech Teva
11/09/2020 Zovirax Acyclovir Bausch & Lomb Amneal
11/09/2020 Taytulla Norethindrone Acetate / Ethinyl Estradiol Allergan Chemo Research
11/10/2020 Prograf Tacrolimus Astellas Glenmark
11/10/2020 Prograf Tacrolimus Astellas Biocon Pharma
11/10/2020 Prograf Tacrolimus Astellas Concord Biotech/Lupin
11/10/2020 Kenalog Triamcinolone Acetonide CMP Pharma Cintex Svcs
11/10/2020 Cleocin T Clindamycin Phosphate Pfizer Taro Pharms
11/12/2020 Prograf Tacrolimus Astellas Alkem Labs
11/12/2020 Nexavar Sorafenib Tosylate Bayer Teva
11/12/2020 Questran Light Cholestyramine Light Bristol-Myers Squibb Tagi
11/12/2020 Astepro Azelastine HCl Mylan Aurobindo
11/13/2020 Vazculep Phenylephrine HCl Exela Aurobindo
11/13/2020 Cosmogen Dactinomycin Recordati Rare Diseases Hong Kong
11/13/2020 Sabril Vigabatrin Lundbeck Accord Healthcare
11/17/2020 Depakote Divalproex Sodium AbbVie Teva
11/17/2020 Faslodex Fulvestrant AstraZeneca Accord Healthcare
11/18/2020 Procardia XL Nifedipine Pfizer Elite
11/18/2020 Nexium Esomeprazole Magnesium AstraZeneca Amta
11/20/2020 Deltasone Prednisone Pharmacia/Upjohn Strides
11/20/2020 Renvela Sevelamer Carbonate Genzyme Impax/Amneal
11/20/2020 Quelicin Succinylcholine Chloride Pfizer Fresenius Kabi
11/23/2020 Dacogen Decitabine Otsuka Apotex
11/23/2020 Precedex Dexmedetomidine HCl Hospira Tagi
11/23/2020 Cialis Tadalafil Eli Lilly Sunshine
11/24/2020 Lodine XL Etodolac Wyeth Bayshore Pharms
11/24/2020 Transderm SCOP Scopolamine Glaxo Riconpharma
11/24/2020 Quelicin Succinylcholine Chloride Pfizer Micro Labs
11/25/2020 Viagra Sildenafil Citrate Upjohn Watson
11/25/2020 Axiron Testosterone Eli Lilly Apotex
11/25/2020 Toprol-XL Metoprolol Succinate Aralez Alkem Labs
11/25/2020 Kerydin Tavaborole Anacor Amneal
11/25/2020 Tenoretic Atenolol / Chlorthalidone Almatica Unichem
11/25/2020 Intuniv Guanfacine HCl Takeda Yichang Humanwell
11/27/2020 Kepra XR Levetiracetam UCB Sciegen Pharms
11/27/2020 Azopt Brinzolamide Novartis Watson
11/27/2020 Hiprex Methenamine Hippurate Validus Riconpharma
11/27/2020 Alinia Nitazoxanide Romark Rising
11/27/2020 Hygroton Chlorthalidone Sanofi Aventis Ajanta Pharma
11/30/2020 Wellbutrin XL Bupropion HCl Valeant Sun Pharm
11/30/2020 Ranexa Ranolazine Gilead Alkem Labs
11/30/2020 Depen Penicillamine Mylan Lupin
12/1/2020 Lidoderm Lidocaine Teikoku Noven Pharms
12/2/2020 Cuprimine Penicillamine Valeant Granules
12/2/2020 Diulo Metolazone GD Searle Alembic Pharms
12/2/2020 Sabril Vigabatrin Lundbeck Alkem Labs
12/3/2020 Celebrex Celecoxib GD Searle Sciegen Pharms
12/3/2020 Acular Ketorolac Tromethamine Allergan Aurobindo
12/3/2020 Norvir Ritonavir AbbVie Hikma
12/3/2020 Morphine Sulfate Morphine Sulfate Hikma Alkem Labs
12/4/2020 Xeloda Capecitabine Hoffman La Roche Dr Reddys Labs
12/4/2020 Welchol Colesevelam HCl Daiichi Sankyo Inventia
12/4/2020 Xenazine Tetrabenazine Bausch & Lomb Ajanta Pharma
12/7/2020 Precedex Dexmedetomidine HCl Pfizer Aurobindo
12/7/2020 Dacogen Decitabine Otsuka Nivagen Pharms
12/8/2020 Emend IV Fosaprepitant Dimeglumine Merck Sandoz
12/8/2020 Rubramin PC Cyanocobalamin Bristol-Myers Squibb Aurobindo
12/9/2020 Afinitor Everolimus Novartis Par Pharm
12/9/2020 Emend IV Fosaprepitant Dimeglumine Merck Dr Reddys Ltd
12/9/2020 Onfi Clobazam Lundbeck Celltrion
12/9/2020 Celebrex Celecoxib GD Searle Acic Pharms
12/10/2020 Saphris Asenapine Maleate AbbVie Breckenridge
12/10/2020 Saphris Asenapine Maleate AbbVie Alembic Pharms
12/10/2020 Saphris Asenapine Maleate AbbVie Sigmapharm Labs
12/10/2020 Acticlate Doxycycline Hyclate Almirall Nostrum Labs
12/10/2020 Nitropress Sodium Nitroprusside Hospira Aurobindo Pharma
12/10/2020 Prilosec Omeprazole P&G Xiromed
12/11/2020 Namenda Memantine HCl Allergan Polygen Pharms
12/11/2020 Gemcitabine HCl Gemcitabine HCl Hospira Nanjing King-Friend
12/11/2020 Versed Midazolam HCl Hoffman La Roche Hikma
12/14/2020 Immodium Multi-Symptom Relief Loperamide Hydrochloride / Simethicone Johnson & Johnson Aurobindo Pharma
12/14/2020 Amicar Aminocaproic Acid Akorn ANI Pharms
12/15/2020 Renagel Sevelamer HCl Genzyme Mylan
12/15/2020 Akovaz Ephedrine Sulfate Exela Hikma
12/16/2020 Methylin Methylphenidate HCl SpecGx Lannett
12/16/2020 Lodine Etodolac Wyeth Bayshore Pharms
12/16/2020 Jublia Efinaconazole Bausch & Lomb Teva
12/16/2020 Jublia Efinaconazole Bausch & Lomb Perrigo
12/16/2020 Firazyr Icatibant Acetate Shire Nang Kuang Pharm
12/16/2020 Acticlate Doxycycline Hyclate Almirall Epic Pharma
12/17/2020 Vytorin Ezetimibe / Simvastatin Merck Mylan
12/17/2020 Welchol Colesevelam HCl Daiichi Sankyo Lupin
12/17/2020 Advair Diskus Fluticasone Propionate / Salmeterol Xinafoate Glaxo Hikma
12/17/2020 Ditropan Oxybutynin Chloride Janssen Strides Pharma
12/18/2020 Gilenya Fingolimod HCl Novartis Apotex
12/18/2020 Lasix Furosemide Sanofi Aventis Areva Pharms
12/18/2020 Taytulla Norethindrone Acetate / Ethinyl Estradiol Allergan Slayback Pharma
12/18/2020 Banzel Rufinamide Eisai Lupin
12/18/2020 Apresoline Hydralazine HCl Novartis Hikma
12/18/2020 Amidate Etomidate Pfizer Caplin
12/21/2020 Quelicin Succinylcholine Chloride Pfizer Deva Holding
12/23/2020 Trilipix Fenofibric Acid AbbVie Yichang Humanwell
12/28/2020 Glucagon Glucagon Eli Lilly Amphastar Pharms
12/28/2020 Latuda Lurasidone HCl Sunovion Piramal Healthcare
12/29/2020 Cialis Tadalafil Eli Lilly Glenmark
12/29/2020 Potassium Chloride Potassium Chloride Merck Ascent Pharms
12/29/2020 Liquaemin Sodium Heparin Sodium Organon Be Pharms
12/29/2020 Liquaemin Sodium Heparin Sodium Organon Be Pharms
12/30/2020 Levaquin in Dextrose 5% in Plastic Container Levofloxacin in Dextrose 5% in Plastic Container Janssen Gland Pharma
12/30/2020 Gilenya Fingolimod HCl Novartis Alkem Labs
12/31/2020 Wellbutrin XL Bupropion HCl Valeant Sun Pharm
12/31/2020 Zyprexa Olanzapine Eli Lilly Pharmtak
12/31/2020 Zyprexa Olanzapine Eli Lilly Pharmtak
12/31/2020 Cleocin T Clindamycin Phosphate Pfizer Gage Development

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

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