ANDA Approvals

Summer 2019

GENERICally Speaking: A Hatch Waxman Litigation Bulletin
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
3/20/2019 Optivar azelastine 0.05% solution Mylan Alembic
3/26/2019 Xyzal Allergy 24HR levocetrizine UCB Perrigo
3/28/2019 Letairis ambrisentan Gilead Teva
3/28/2019 Letairis ambrisentan Gilead Mylan
3/28/2019 Letairis ambrisentan Gilead Zydus
3/28/2019 Letairis ambrisentan Gilead Sun
3/29/2019 Klor-Con potassium chloride Upsher-Smith Pharmaceutics Int'l
3/29/2019 Azilect rasagiline Teva Micro Labs
4/1/2019 Taxotere docetaxel Sanofi Mylan
4/1/2019 Xyzal levocetrizine UCB Hetero
4/2/2019 Marcaine bupivacaine Hospira B. Braun
4/2/2019 BiCNU carmustine Emcure STI Pharma
4/4/2019 Livalo pitavastatin Kowa Mylan
4/4/2019 Pataday olopatadine Novartis Aurobindo
4/5/2019 Acular ketorolac Allergan Micro Labs
4/5/2019 Zantac ranitidine Glaxo Appco
4/8/2019 Xenazine tetrabenazine Bausch Hikma
4/8/2019 Anafril clomipramine SpecGx Mankind
4/9/2019 Crestor rosuvastatin AstraZeneca Umedica
4/9/2019 Makena hydroxyprogesterone AMAG Sun
4/10/2019 Androgel 1.62% testosterone AbbVie Lupin
4/10/2019 Naftine naftifine Sebela Taro
4/10/2019 Letairis ambrisentan Gilead Sigmapharm
4/10/2019 Letairis ambrisentan Gilead Par
4/10/2019 Nexium esomeprazole AstraZeneca Amneal
4/10/2019 Nitropress sodium nitroprusside Hospira Dr. Reddy's Labs
4/12/2019 Lumigan 0.03% bimatoprost Allergan Alembic
4/15/2019 Acticlate doxycycline Almirall Apotex
4/16/2019 Makena hydroxyprogesterone AMAG Eugia
4/16/2019 Tylenol acetaminophen Johnson & Johnson Granules
4/17/2019 Lotemax loteprednol Bausch Akorn
4/17/2019 Flonase fluticasone Glaxo Akorn
4/17/2019 Evekeo amphetamine Arbor Aurobindo
4/19/2019 Narcan naloxone Adapt Teva
4/19/2019 Valstar valrubicin Endo Custopharm
4/19/2019 Starlix nateglinide Novartis Zydus
4/19/2019 Canasa mesalamine Teva PSP
4/19/2019 Augmentin amoxicillin / clavulanate potassium Neopharma Aurobindo
4/19/2019 Aubagio teriflunomide Sanofi Alembic
4/19/2019 Afinitor Disperz everolimus Novartis Mylan
4/23/2019 Banzel rufinamide Eisai Hikma
4/23/2019 Banzel rufinamide Eisai Bionpharma
4/23/2019 Concerta methylphenidate Johnson & Johnson Lannett
4/24/2019 Depo-Testosterone testosterone cypionate Pfizer Wilshire
4/24/2019 Nebupent pentamidine Fresenius Kabi Seton
4/24/2019 Aubagio teriflunomide Sanofi MSN
4/24/2019 Arava leflunomide Sanofi Zydus
4/24/2019 Zyvox linezolid Pfizer Celltrion
4/26/2019 Tracleer bosentan Actelion Zydus
4/26/2019 Letairis ambrisentan Gilead Cipla
4/26/2019 Tracleer bosentan Actelion Par
4/26/2019 Tracleer bosentan Actelion Alvogen
4/26/2019 Tracleer bosentan Actelion Natco
4/26/2019 Tracleer bosentan Actelion Teva
4/26/2019 Tracleer bosentan Actelion Zydus
4/26/2019 Tracleer bosentan Actelion Hikma
4/26/2019 Tracleer bosentan Actelion Sun
4/26/2019 Tracleer bosentan Actelion Amneal
4/26/2019 K-Tab potassium chloride AbbVie Pharmaceutics Int'l
4/29/2019 Cialis tadalafil Eli Lilly Mylan
4/29/2019 Pataday olopatadine Alcon Alembic
4/30/2019 Klor-Con potassium chloride Upsher-Smith Prinston
4/30/2019 Nitrostat nitroglycerin Pfizer Alvogen
5/1/2019 Epivir lamivudine ViiV Macleods
5/1/2019 Cubicin daptomycin Merck Dr. Reddy’s Labs.
5/3/2019 Alkeran melphalan Akorn US World Meds
5/6/2019 Voltaren diclofenac Glaxo Mylan
5/6/2019 Trisenox arsenic trioxide Teva STI Pharma
5/6/2019 Welchol colesevelam Daiichi Sankyo Alkem
5/6/2019 Klor-Con potassium chloride Upsher-Smith Belcher
5/7/2019 Pristiq desvenlafaxine Pfizer IntelliPharmaceutics
5/7/2019 Cuprimine penicillamine Bausch Amerigen
5/7/2019 Busulfex busulfan Otsuka Apotex
5/9/2019 Nuvigil armodafinil Teva Mylan
5/10/2019 Kuvan sapropterin Biomarin Par
5/10/2019 Aleve PM naproxen / diphenhydramine Bayer Perrigo
5/10/2019 Nexium esomeprazole AstraZeneca Glenmark
5/13/2019 Actonel risedronate Allergan Orchid
5/13/2019 Trandate labetalol lotion County Line Zydus
5/14/2019 Albenza albendazole Amneal Edenbridge
5/15/2019 Zometa zoledronic acid Novartis Shilpa
5/16/2019 Taxotere docetaxel Sanofi Shilpa
5/16/2019 Voltaren diclofenac Glaxo Perrigo
5/17/2019 Latuda lurasidone Sunovion Teva
5/17/2019 Sensipar cinacalcet HCl Amgen Alkem
5/17/2019 Mycamine micafungin Astellas Fresenius Kabi
5/17/2019 Astelin azelastine Mylan Akorn
5/17/2019 Adderall XR dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate Shire Sun
5/17/2019 Adderall XR dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate Shire Rhodes
5/20/2019 Cosmegen dactinomycin Recordati X-Gen
5/20/2019 Vesicare solifenacin Astellas Ajanta
5/20/2019 Vesicare solifenacin Astellas Alembic
5/20/2019 Vesicare solifenacin Astellas Glenmark
5/20/2019 Vesicare solifenacin Astellas Qilu
5/20/2019 Vesicare solifenacin Astellas Amneal
5/20/2019 Vesicare solifenacin Astellas Breckenridge
5/20/2019 Vesicare solifenacin Astellas Cipla
5/20/2019 Vesicare solifenacin Astellas Jiangxi Boya
5/20/2019 Vesicare solifenacin Astellas Airis Pharma
5/20/2019 Vesicare solifenacin Astellas ScieGen
5/21/2019 Ampyra dalfampridine Acorda Sun
5/22/2019 Nexium esomeprazole AstraZeneca Zydus
5/22/2019 Vitamin K phytonadione Hospira Dr. Reddy’s Labs.
5/22/2019 Syprine trientine Aton MSN
5/24/2019 Aggrenox aspirin / dipyridamole Boehringer-Ingelheim Glenmark
5/28/2019 Ranexa ranolazine Gilead Ajanta
5/28/2019 Ranexa ranolazine Gilead Cipla
5/28/2019 Ranexa ranolazine Gilead Sun
5/31/2019 Adderall XR dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate Shire Par
5/31/2019 Felbatol felbamate Mylan Vistapharm
5/31/2019 Revatio sildenafil Pfizer Novitium
6/3/2019 Xibrom bromfenac Bausch Pfizer
6/3/2019 Atripla efavirenz / emtricitabine / tenofovir Gilead Cipla
6/3/2019 Arava leflunomide Sanofi Abhai
6/4/2019 Ranexa ranolazine Gilead ScieGen
6/5/2019 Sinemet CR carbidopa/levodopa Alembic
6/5/2019 Nexium 24hr esomeprazole AstraZeneca Amneal
6/5/2019 K-Tab potassium chloride AbbVie Adare Pharms
6/6/2019 DDAVP desmopressin Ferring Novast
6/11/2019 Tygacil tigecycline Pfizer Aurobindo
6/11/2019 Klor-Con potassium chloride Upsher-Smith Prinston
6/12/2019 Canasa mesalamine Allergan Sandoz
6/12/2019 Invega paliperidone Johnson & Johnson Inventia
6/12/2019 Claritin loratadine Bayer Perrigo
6/13/2019 Cosopt dorzolamide HCl / timolol maleate Akorn FDC
6/14/2019 Lovaza omega-3-acid ethyl esters Glaxo Zydus
6/14/2019 Cardizem CD diltiazem HCl Bausch Novast Labs
6/17/2019 K-Tab potassium chloride AbbVie PII
6/18/2019 Dyloject diclofenac sodium Pfizer Mylan
6/18/2019 Diamox acetazolamide Teva Mylan
6/19/2019 Transderm Scop scopolamine Glaxo Mylan
6/19/2019 Lumigan 0.03% bimatoprost Allergan Somerset Therapeutics
6/20/2019 Cytovene ganciclovir sodium Roche Custopharm
6/20/2019 Sodium Bicarbonate sodium bicarbonate Abbott Labs Exela Pharma SCS
6/21/2019 Canasa mesalamine Allergan Amring Pharms
6/21/2019 Xeloda capecitabine Hoffmann La Roche Sun
6/21/2019 Dexedrine dextroamphetamine sulfate Impax Labs PII
6/21/2019 Xibrom bromfenac sodium Bausch and Lomb Alembic
6/24/2019 Tamiflu oseltamivir phosphate Gilead Alembic
6/24/2019 Cubicin daptomycin Merck Accord Healthcare
6/24/2019 Cuprimine penicillamine Valeant Teva
6/25/2019 Cosopt dorzolamide HCl / timolol maleate Akorn Somerset Therapeutics
6/26/2019 Aczone gel 7.5% dapsone Allergan Taro
6/26/2019 Bethkis tobramycin Chiesi Teva
6/26/2019 Bactrim sulfamethoxazole / trimethoprim Sun Somerset Therapeutics
6/26/2019 Cubicin daptomycin Cubist BE Pharms
6/27/2019 Vytorin ezetimibe / simvastatin Pfizer Glenmark
6/27/2019 Medrol methylprednisolone Pharmancia and Upjohn Sungen Pharma
6/28/2019 Sensipar cinacalcet HCl Amgen Lupin
6/28/2019 Isuprel isoproterenol HCl Bausch Cipla
6/28/2019 Ultram tramadol HCl Janssen Rubicon
6/28/2019 Klonopin clonazepam Hoffmann La Roche Alembic

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