ANDA Approvals Spring 2020 | Hatch-Waxman Litigation

Spring 2020

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