ANDA Approvals

Spring 2020

Robins Kaplan 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
01/02/2020 Canasa Mesalamine Allergan Amneal
01/02/2020 Jadenu Deferasirox Novartis Sun Pharm
01/03/2020 Exjade Deferasirox Novartis Ichnos
01/03/2020 Tracleer Bosentan Actelion Cipla
01/03/2020 Anexsia 5/325 Hydrocodone Bitartrate / Acetaminophen SpecGx Granules Pharms
01/06/2020 Enablex Darifenacin Hydrobromide Allergan Polygen Pharms
01/06/2020 Inderal LA Propranolol HCl ANI Pharma Amta
01/07/2020 D.H.E. 45 Dihydroergotamine Mesylate Bausch & Lomb Apollo
01/08/2020 Haldol Haloperidol Ortho McNeil Appco
01/08/2020 Nicorette Nicotine Polacrilex GlaxoSmithKline Dr Reddys
01/09/2020 Mestinon Pyridostigmine Bromide Bausch & Lomb Invatech
01/09/2020 Lavaza Omega-3-Acid Ethyl Esters Glaxo Sun Pharm
01/10/2020 Viibryd Vilazodone HCl Allergan Alembic Pharms
01/10/2020 Tepadina Thiotepa Amneal Sti Pharma
01/10/2020 Lyrica Pregabalin Pfizer Cipla
01/10/2020 Mestinon Pyridostigmine Bromide Bausch & Lomb Amneal
01/13/2020 Valcyte Valganciclovir HCl Roche Ajanta Pharma
01/13/2020 Zanaflex Tizanidine HCl Covis Alembic Pharms
01/14/2020 Cyklokapron Tranexamic Acid Pharmacia & Upjohn Apotex
01/14/2020 Urocit K Potassium Citrate Mission Ani Pharms
01/15/2020 Tracleer Bosentan Actelion Mylan
01/15/2020 Anectine / Quelicin Succinylcholine Chloride Sandoz / Hospira Somerset Theraps
01/15/2020 Claritin Loratadine Bayer Strides Pharma
01/16/2020 Wellbutrin Bupropion HCl GlaxoSmithKline Cadila Pharms
01/16/2020 Vazculep Phenylephrine HCL Avadel Riconpharma
01/17/2020 Narcan Naloxone HCl Adapt Par Sterile Products
01/17/2020 Tricor Fenofibrate AbbVie Alembic Pharms
01/17/2020 Thorazine Chlorpromazine HCl GlaxoSmithKline Zydus
01/21/2020 Zohydro ER Hydrocodone Bitartrate Persion Alvogen
01/21/2020 Latisse Bimatoprost Allergan Alembic Pharms
01/22/2020 Xenazine Tetrabenazine Bausch & Lomb Piramal
01/23/2020 Tracleer Bosentan Actelion Alembic Pharms
01/24/2020 Detrol Tolterodine Tartrate Pharmacia & Upjohn Unique Pharm Labs
01/24/2020 Yasmin Drospirenone / Ethinyl Estradiol Bayer Hetero Labs
01/24/2020 Methotrexate Sodium Methotrexate Sodium Dava Accord Healthcare
01/27/2020 Voltaren 1% Diclofenac Sodium GlaxoSmithKline Encube
01/27/2020 Zithromax Azithromycin Pfizer Alembic Pharms
01/27/2020 Oxycodone HCl Oxycodone HCl Genus Life Aurolife Pharma
01/27/2020 Cormax Clobetasol Propionate Hi Tech Aleor Dermaceuticals
01/28/2020 Patanase Olopatadine HCl Novartis Amneal
01/28/2020 Zithromax Azithromycin Pfizer Alembic Pharms
01/29/2020 Tikosyn Dofetilide Pfizer MSN
01/30/2020 Precedex Dexmedetomidine HCl Hospira Hikma
01/30/2020 Methotrexate Sodium Methotrexate Sodium Dava Eugia Pharma
01/31/2020 Onfi Clobazam Lundbeck Teva
01/31/2020 Valcyte Valganciclovir HCl Roche Granules Pharms
02/03/2020 Calcijex Calcitriol AbbVie Gland Pharma
02/04/2020 Arava Leflunomide Sanofi Lupin
02/04/2020 Evekeo Amphetamine Sulfate Arbor Cerovene
02/05/2020 Desyrel Trazodone HCl Pragma Aurolife Pharma
02/05/2020 Hicon Sodium Iodide I 131 Jubilant DraxImage Intl Isotopes
02/05/2020 Colcrys Colchicine Takeda Granules Pharms
02/06/2020 Technescan Mag3 Technetium TC99M Mertiatide Kit Curium Sommer Pharms
02/06/2020 Fludeoxyglucose F-18 Fludeoxyglucose F18 Feinstein Institute Univ Texas SW Med Ctr
02/07/2020 Marinol Dronabinol Alkem Ascent Pharms
02/07/2020 Anafranil Clomipramine HCl SpecGx Leading Pharma
02/07/2020 Faslodex Fulvestrant Astra-Zeneca Chia Tai Tianqing
02/07/2020 Hectorol Doxercalciferol Sanofi Genzyme Meitheal
02/07/2020 Norco Hydrocodone Bitartrate / Acetaminophen Teva Xiromed
02/10/2020 Vanos Fluocinonide Bausch Cadila
02/11/2020 Exjade Deferasirox Novartis Cipla
02/11/2020 Hygroton Chlorthalidone Sanofi Aventis Alkem Labs
02/12/2020 Canasa Mesalamine Allergan Zydus Pharms
02/12/2020 Ranexa Ranolazine Gilead Mankind Pharma
02/12/2020 Actigall Ursodiol Allergan Rising
02/13/2020 Depen Penicillamine Mylan Teva
02/14/2020 Rapaflo Silodosin Allergan Hetero Labs
02/14/2020 DDAVP Desmopressin Acetate Ferring UBI
02/18/2020 Vimovo Naproxen / Esomeprazole Magnesium Horizon Dr Reddys
02/18/2020 Evomela Melphalan HCl Acrotech Ingenus Pharms
02/18/2020 Singulair Montelukast Sodium Merck Aurobindo
02/19/2020 Arthrotec Diclofenac Sodium / Misoprostol Pfizer Yung Shin Pharm
02/19/2020 Pazeo Olopatadine Hydrochloride Novartis Watson
02/19/2020 Zometa Zoledronic Acid Novartis Ingenus Pharms
02/19/2020 Edecrin Ethacrynic Acid Bausch & Lomb Upsher Smith
02/20/2020 Syprine Trientine HCl Bausch & Lomb Rising
02/20/2020 Lomotil Diphenoxylate HCl / Atropine Sulfate GD Searle Leading Pharma
02/21/2020 Robinul Glycopyrrolate Hikma Riconpharma
02/21/2020 PhosLo GelCaps Calcium Acetate Fresenius Suven Life
02/21/2020 Naprosyn Naproxen Atnahs Sciegen Pharms
02/21/2020 Nicorette Nicotine Polacrilex Glaxo Dr Reddys
02/24/2020 ProAir HFA Albuterol Sulfate Teva Perrigo
02/24/2020 Onfi Clobazam Lundbeck Hetero Labs
02/24/2020 Heparin Sodium Heparin Sodium Fresenius Kabi Nanjing King-Friend
02/24/2020 Allegra Allergy Fexofenadine HCl Sanofi Perrigo
02/25/2020 Celebrex Celecoxib GD Searle Tianjin Tianyao
02/25/2020 Astelin Azelastine HCl Meda Gland Pharma
02/26/2020 Amicar Aminocaproic Acid Clover Vistapharm
02/27/2020 Ranexa Ranolazine Gilead Micro Labs
02/28/2020 Namenda XR Memantine HCl Allergan Ani Pharms
02/28/2020 Daraprim Pyrimethamine Turing Cerovene
02/28/2020 Namenda Memantine HCl Allergan Hikma Pharms
02/28/2020 Aubagio Teriflunomide Sanofi Mylan
02/28/2020 Migranal Dihydroergotamine Mesylate Bausch & Lomb Custopharm
02/28/2020 Truvada Emtricitabine / Tenofovir Disoproxil Fumarate Gilead Zydus Pharms
02/28/2020 Depakote Divalproex Sodium AbbVie Ajanta Pharma
03/02/2020 Viagra Sildenafil Citrate Pfizer Appco
03/02/2020 Symmetrel Amantadine HCl Endo Invatech
03/03/2020 Riomet Metformin HCl Sun Saptalis Pharms
03/03/2020 Achromycin V Tetracycline HCl Avet Pharma Strides Pharma
03/04/2020 Topicort Desoximetasone Taro Cosette
03/04/2020 Periostat Doxycycline Hyclate Galderma Alembic Pharms
03/04/2020 Westcort Hydrocortisone Valerate Sun Cosette
03/04/2020 Klor-Con Potassium Chloride Upsher-Smith Granules Pharms
03/04/2020 Tamiflu Oseltamivir Phosphate Gilead Sunshine Lake
03/04/2020 Tepadina Thiotepa Amneal MSN
03/06/2020 Kytril Granisetron HCl Hoffman La Roche Yung Shin Pharm
03/06/2020 Evomela Melphalan HCl Acrotech Actavis
03/06/2020 Celebrex Celecoxib GD Searle Yiling Pharm
03/09/2020 Firazyr Icatibant Acetate Takeda Jiangsu Hansoh Pharm
03/10/2020 Staxyn Vardenafil HCl Bayer Macleods
03/10/2020 Symmetrel Amantadine HCl Endo Invatech
03/11/2020 PediaPred Prednisolone Sodium Phosphate Seton Pharma Pharm Assoc
03/11/2020 Pradaxa Dabigatran Etexilate Mesylate BI Alkem Labs
03/11/2020 Evoclin Clindamycin Phosphate Mylan Taro Pharm
03/11/2020 Evekeo Amphetamine Sulfate Arbor Prinston
03/12/2020 Effexor XR Venlafaxine HCl Pfizer Inventia Healthcare
03/16/2020 Methadose Methadone HCl SpecGx Vistapharm
03/16/2020 Kyprolis Carfilzomib Bayer Apotex
03/16/2020 Zarontin Ethosuximide Pfizer Puracap Pharm
03/16/2020 Vibra-Tabs Doxycycline Hyclate Pfizer Oaklock
03/16/2020 Xylocaine Lidocaine Astra-Zeneca Macleods
03/16/2020 Narcan Naloxone HCl Adapt Dr Reddys
03/17/2020 Xenazine Tetrabenazine Bausch Apotex
03/17/2020 Bromday Bromfenac Sodium Bausch Gland Pharma
03/17/2020 Isoptin Verapamil HCl Mt. Adams Technologies Areva Pharms
03/18/2020 Valtrex Valacyclovir HCl GlaxoSmithKline Yiling Pharm
03/18/2020 Tricor Fenofibrate AbbVie Graviti Pharms
03/18/2020 Triamcinolone Acetonide Triamcinolone Acetonide Mylan Strides Pharma
03/19/2020 Canasa Mesalamine Allergan Annora Pharma
03/20/2020 Integrelin Eptifibatide Merck Hybio
03/20/2020 Kyprolis Carfilzomib Bayer Apotex
03/20/2020 Lyrica Pregabalin Pfizer Celltrion
03/23/2020 Nexium Esomeprazole Magnesium Astra-Zeneca Cipla
03/23/2020 Nexium Esomeprazole Magnesium Astra-Zeneca Cipla
03/23/2020 Ranexa Ranolazine Gilead Sunshine Lake
03/23/2020 Ranexa Ranolazine Gilead Sungen Pharma
03/23/2020 Lyrica Pregabalin Pfizer Hikal
03/24/2020 Focalin Dexmethylphenidate HCl Novartis Bionpharma
03/24/2020 Primacor Milrinone Lactate Sanofi Aventis Nanjing King-Friend
03/24/2020 Zanaflex Tizanidine HCl Covis Aurobindo
03/25/2020 Prilosec OTC Omeprazole Magnesium Astra-Zeneca Hetero Labs
03/25/2020 Mucinex D Guaifenesin / Pseudoephedrine HCl Reckitt Benckiser Aurobindo
03/25/2020 Isoptin Verapamil HCl Mt. Adams Technologies Caplin
03/27/2020 Azasan Azathioprine AAIPharma Alkem Labs
03/27/2020 Levothyroxine sodium powder Levothyroxine Sodium Fresenius-Kabi Dr Reddys
03/30/2020 Toprol-XL Metoprolol Succinate Toprol Acquisition Pharmadax
03/30/2020 Suboxone Buprenorphine HCl / Naloxone HCl Indivior Rhodes Pharms
03/30/2020 Vigamox Moxifloxacin HCl Novartis Mylan
03/30/2020 Daliresp Roflumilast Astra-Zeneca Strides Pharma
03/30/2020 Vigamox Moxifloxacin HCl Novartis Gland Pharma
03/30/2020 Jadenu Deferasirox Novartis Alkem Labs
03/30/2020 Methylin Methylphenidate HCl SpecGx Alkem Labs
03/31/2020 Toprol-XL Metoprolol Succinate Toprol Acquisition Pharmadax
03/31/2020 Vfend Voriconazole PF Prism Gland Pharma
03/31/2020 Vibramycin Doxycycline Hyclate Pfizer Zhejiang Yongtai
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