ANDA Approvals

First 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
01/04/2021 Cyanocobalamin cyanocobalamin American Regent Sandoz
01/05/2021 Xylocaine lidocaine AstraZeneca Dr Reddys Labs
01/05/2021 Bactrim sulfamethoxazole / trimethoprim Sun Lupin
01/06/2021 Tirosint levothyroxine sodium IBSA Teva
01/07/2021 Biorphen phenylephrine HCl Hikma Aurobindo
01/07/2021 Pentam pentamidine isethionate Fresenius Kabi Emcure Pharms
01/07/2021 Prolixin fluphenazine HCl BMS Cerovene
01/07/2021 Claritin loratadine Bayer Unique Pharm
01/11/2021 Axiron testosterone Eli Lilly Fempharm
01/11/2021 Zovirax acyclovir Mylan Vistapharm
01/12/2021 Emend fosaprepitant dimeglumine Merck Aurobindo
01/12/2021 Celebrex celecoxib Pfizer Unichem
01/13/2021 Truvada emtricitabine / tenofovir disoproxil fumarate Gilead Strides
01/13/2021 Rayven (NuvaRing) ethinyl estradiol / etonogestrel Merck Teva
01/13/2021 Adderall 30 dextroamp saccharate / amp aspartate / dextroamp sulfate / amp sulfate Teva Rhodes Pharms
01/13/2021 Lopid gemfibrozil Pfizer Ascent Pharms
01/14/2021 Taxotere docetaxel Sanofi Aventis Hikma
01/14/2021 Renvela sevelamer carbonate Genzyme Lupin
01/14/2021 Targretin bexarotene Bausch & Lomb Teva
01/14/2021 Glumetza ER metformin HCl Bausch & Lomb Granules
01/15/2021 Feraheme ferumoxytol AMAG Sandoz
01/15/2021 Veletri epoprostenol sodium Actelion Sun
01/15/2021 Lioresal baclofen Saol Therapies Maia Pharms
01/15/2021 Methergine methylergonovine maleate Edison Therapeutics Rising
01/15/2021 CellCept mycophenolate mofetil HCl Roche Nanjing King-Friend (Meitheal)
01/19/2021 Gilenya fingolimod HCl Novartis Mylan
01/19/2021 Lamictal ODT lamotrigine Glaxo Ajanta Pharma
01/21/2021 Monodox doxycycline Chartwell Mylan
01/21/2021 Tamiflu oseltamivir phosphate Roche Mylan
01/21/2021 Venlafaxine Hydrochloride venlafaxine hydrochloride Osmotica Dexcel Pharma
01/21/2021 Argatroban argatroban Eagle Caplin
01/21/2021 ProAmtine midodrine HCl Takeda Alembic Pharms
01/22/2021 Actos pioglitazone HCl Takeda Shuangcheng
01/22/2021 Actigall ursodiol AbbVie Strides
01/22/2021 Tobi tobramycin Mylan Aurobindo
01/22/2021 Thorazine chlorpromazine HCl Glaxo Lannett
01/22/2021 Albenza albendazole Amneal MSN
01/22/2021 Evekeo amphetamine sulfate Arbor SpecGx
01/22/2021 Levophed norepinephrine bitartrate Hospira Breckenridge
01/22/2021 Cytomel liothyronine sodium King Zydus
01/25/2021 Trisenox arsenic trioxide Teva Amneal
01/25/2021 Mexitil mexiletine HCl Boehringer-Ingelheim Riconpharma
01/26/2021 Zyclara 3.75% imiquimod Galderma Taro
01/26/2021 Albenza albendazole Amneal Dr Reddys Labs
01/26/2021 Sabril vigabatrin Lundbeck Annora Pharma
01/26/2021 Amicar aminocaproic acid Akorn Leading Pharma
01/26/2021 Zonegran zonisamide Sunovion Unichem
01/27/2021 Lomotil diphenoxylate HCl / atropine sulfate Pfizer Winder Labs
01/27/2021 Evekeo amphetamine sulfate Arbor Glenmark
01/27/2021 Evekeo amphetamine sulfate Arbor Sun
01/27/2021 Furosemide furosemide American Regent Athenex
01/28/2021 Pennsaid 1% diclofenac sodium Horizon Akorn
01/28/2021 Ranexa ranolazine Gilead Graviti Pharms
01/28/2021 K-Tab potassium chloride AbbVie AMTA
01/29/2021 Methylin methylphenidate hydrochloride SpecGx Ascent Pharms
01/29/2021 Sabril vigabatrin Lundbeck Dr Reddys Labs
01/29/2021 Levophed norepinephrine bitartrate Hospira Sun
01/29/2021 Foscavir foscarnet sodium Clinigen Fresenius Kabi USA
01/29/2021 Potassium Chloride potassium chloride Genus Granules
01/29/2021 Narcan naloxone hydrochloride Adapt Baxter Healthcare
02/01/2021 Qudexy XR topiramate Upsher-Smith Glenmark
02/01/2021 Prevacid lansoprazole Takeda Dr Reddys Labs
02/01/2021 Noxafil posaconazole Merck Aet Pharma
02/02/2021 Seroquel XR quetiapine fumarate AstraZeneca Mylan
02/02/2021 Latuda lurasidone HCl Sunovion Teva
02/02/2021 Detrol LA tolterodine tartrate Pfizer AMTA
02/03/2021 Kerydin tavaborole Anacor Identirx
02/05/2021 Crestor rosuvastatin calcium IPR Inventia
02/05/2021 Triamcinolone Acetonide triamcinolone acetonide Mylan Perrigo
02/05/2021 Dermotic fluocinolone acetonide Hill Tasman Pharma
02/05/2021 Urocit-K potassium citrate Mission Ascent Pharms
02/08/2021 Kerydin tavaborole Anacor Lupin
02/08/2021 Embeline clobetasol propionate Akorn Prinston
02/09/2021 Nebcin tobramycin sulfate Eli Lilly Gland Pharma
02/09/2021 Linzess linaclotide AbbVie Mylan
02/09/2021 Isuprel isoproterenol HCl Bausch & Lomb Aurobindo
02/09/2021 Kerydin tavaborole Anacor Cipla
02/09/2021 Jadenu Sprinkle deferasirox Novartis Amneal
02/10/2021 Tricor fenofibrate AbbVie AustarPharma
02/10/2021 Sterile Water for Injection sterile water for injection Hospira Nephron
02/10/2021 Lotemax loteprednol etabonate Bausch & Lomb Akorn
02/10/2021 Vigamox moxifloxacin HCl Novartis Upsher-Smith
02/10/2021 Cleocin T-gel clindamycin phosphate Pfizer Glenmark
02/10/2021 Myfortic mycophenolic acid Novartis AMTA
02/11/2021 Marcaine bupivacaine HCl Hospira Hikma
02/11/2021 Marcaine HCL bupivacaine HCl Hospira Hikma
02/11/2021 Deltasone prednisone Pharmacia Strides
02/11/2021 Nebcin tobramycin sulfate Eli Lilly Gland Pharma
02/11/2021 Remodulin treprostinil United Therapeutics Alembic Global
02/11/2021 Cymbalta duloxetine HCl Eli Lilly Sunshine
02/11/2021 Westcort hydrocortisone valerate Sun Cosette
02/11/2021 Afinitor everolimus Novartis Biocon Pharma
02/12/2021 Toprol-XL metoprolol succinate Toprol Acquisition Yichang Humanwell
02/12/2021 Amicar aminocaproic acid Akorn Leading Pharma
02/16/2021 Zosyn piperacillin / tazobactam Wyeth Sagent Pharms
02/16/2021 Isuprel isoproterenol HCl Bausch & Lomb Micro Labs
02/16/2021 Paxil CR paroxetine HCl Apotex CSPC Ouyi
02/16/2021 Klor-Con potassium chloride Upsher-Smith Granules
02/17/2021 Imitrex sumatriptan Glaxo Florida
02/17/2021 Otezla apremilast Amgen Unichem
02/18/2021 Strattera atomoxetine HCl Eli Lilly Mylan
02/18/2021 Dymista azelastine HCl / fluticasone propionate Mylan/Cipla Perrigo
02/18/2021 Northera droxidopa Lundbeck Lupin
02/18/2021 Northera droxidopa Lundbeck Annora
02/18/2021 Northera droxidopa Lundbeck MSN
02/18/2021 Northera droxidopa Lundbeck Zydus
02/18/2021 Northera droxidopa Lundbeck Hikma
02/18/2021 Northera droxidopa Lundbeck Teva
02/18/2021 Northera droxidopa Lundbeck Tasman Pharma
02/18/2021 Northera droxidopa Lundbeck Alkem Labs
02/18/2021 Northera droxidopa Lundbeck Sciegen Pharms
02/18/2021 Northera droxidopa Lundbeck Sun
02/18/2021 Northera droxidopa Lundbeck Aurobindo
02/18/2021 Northera droxidopa Lundbeck Ajanta Pharma
02/19/2021 Omnicef cefdinir AbbVie Alkem Labs
02/19/2021 Suprax cefixime Lupin Alkem Labs
02/19/2021 Elavil amitriptyline HCl AstraZeneca Mankind Pharma
02/19/2021 Urocit-K potassium citrate Mission Eywa
02/22/2021 Diamox acetazolamide Teva Appco
02/22/2021 Motrin ibuprofen McNeil Strides Pharma
02/22/2021 Imitrex sumatriptan Glaxo Cipla
02/23/2021 Banzel rufinamide Eisai Alkem Labs
02/23/2021 Excedrin Migraine acetaminophen / aspirin / caffeine Glaxo Granules
02/24/2021 Periactin cyproheptadine HCl Merck Quagen
02/24/2021 Pamelor nortriptyline HCl SpecGx Zydus
02/25/2021 Zamfeny ethinyl estradiol / norelgestromin Johnson & Johnson Amneal
02/26/2021 Nexium esomeprazole magnesium AstraZeneca Indchemie Health
02/26/2021 Lotemax loteprednol etabonate Bausch & Lomb Sun
03/01/2021 Hysingla ER hydrocodone bitartrate Purdue Alvogen Pine Brook
03/01/2021 Sinequan doxepin HCl Pfizer Leading Pharma
03/01/2021 Prolixin fluphenazine HCl Bristol-Myers Squibb Novitium Pharma
03/03/2021 Valcyte valganciclovir HCl Hoffmann La Roche Mylan
03/03/2021 Methadose methadone HCl SpecGx Lannett
03/03/2021 Emend fosaprepitant dimeglumine Merck Chia Tai Tianqing
03/03/2021 Androgel testosterone AbbVie Aleor Dermaceuticals
03/03/2021 Tenex guanfacine HCl Promius Unichem
03/04/2021 Zestril lisinopril Almatica Yiling
03/04/2021 Robinul glycopyrrolate Caspar Xiromed
03/05/2021 Afinitor everolimus Novartis Breckenridge
03/05/2021 Gilenya fingolimod HCl Novartis Dr Reddys Labs
03/05/2021 CellCept mycophenolate mofetil HCl Roche Amneal
03/05/2021 Lioresal baclofen Novartis Kartha
03/08/2021 Tepadina thiotepa Amneal Gland Pharma
03/08/2021 Cleocin T-gel clindamycin phosphate Pfizer Perrigo
03/09/2021 Saphris asenapine maleate Breckenridge Breckenridge
03/09/2021 Questran cholestyramine Bristol-Myers Squibb Tagi
03/09/2021 Vivlodex meloxicam iCeutica Novitium Pharma
03/09/2021 Sinequan doxepin HCl Pfizer Leading Pharma
03/09/2021 Tobrex tobramycin Novartis Gland Pharma
03/09/2021 Potassium chloride in dextrose and sodium chloride Potassium chloride in dextrose and sodium chloride ICU Medical Fresenius Kabi USA
03/09/2021 Glumetza metformin HCl Bausch & Lomb Ajanta Pharma
03/09/2021 Jadenu Sprinkle deferasirox Novartis Aucta
03/10/2021 Naprosyn naproxen Atnahs Novitium Pharma
03/10/2021 Vibra-Tabs doxycycline hyclate Pfizer Oryza
03/11/2021 Strattera atomoxetine HCl Eli Lilly Hetero Labs
03/11/2021 Ranexa ranolazine Gilead Amneal
03/11/2021 Klor-Con potassium chloride Upsher-Smith Strides Pharma
03/11/2021 Cleocin T-gel clindamycin phosphate Pfizer Encube
03/12/2021 BiNCU carmustine Emcure Jiangsu Hengrui Med
03/12/2021 Lincocin lincomycin HCl Pfizer Praxgen
03/12/2021 Rapamune sirolimus Pfizer Alkem
03/15/2021 Aloxi palonosetron HCl Roche Accord Healthcare
03/15/2021 Depakote ER divalproex sodium AbbVie AMTA
03/17/2021 Zithromax azithromycin Pfizer Yung Shin Pharm
03/17/2021 Jadenu Sprinkle deferasirox Novartis MSN
03/18/2021 Potassium Chloride potassium chloride ICU Medical Nexus Pharms
03/19/2021 Travatan Z travoprost Novartis Micro Labs
03/19/2021 Nexium esomeprazole magnesium AstraZeneca Graviti Pharms
03/22/2021 Cardizem SR diltiazem HCl Bausch & Lomb Glenmark
03/23/2021 Thorazine chlorpromazine HCl Glaxo Glenmark
03/25/2021 Hemabate carboprost tromethamine Pfizer Sunny Pharmtech
03/25/2021 Clobex clobetasol propionate Galderma Taro Pharms
03/26/2021 Dextrose 50% dextrose 50% Hospira Int'l Medication Sys
03/26/2021 Tecfidera dimethyl fumarate Biogen Pharmathen
03/26/2021 Cormax clobetasol propionate Akorn Glasshouse Pharms
03/26/2021 Invanz ertapenem sodium Merck Gland Pharma
03/29/2021 Jublia efinaconazole Bausch & Lomb Aurobindo
03/29/2021 Ferriprox deferiprone Chiesi Hikma
03/29/2021 Arava leflunomide Sanofi Aventis Aurobindo
03/29/2021 Quelicin succinylcholine chloride Hospira Sagent Pharms
03/30/2021 Kuvan sapropterin dihydrochloride Biomarin Dr Reddys Labs
03/30/2021 Mepron atovaquone Glaxo Bionpharma
03/30/2021 Zaroxolyn metolazone Lannett Innogenix
03/30/2021 Zaroxolyn metolazone Lannett Bayshore Pharms
03/31/2021 Nexium esomeprazole magnesium AstraZeneca Ethypharm
03/31/2021 Absorica isotretinoin Sun Actavis
03/31/2021 Imbruvica ibrutinib Johnson & Johnson Zydus
03/31/2021 Klor-Con potassium chloride Upsher-Smith Aurobindo

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

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