- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Entertainment and Media Litigation
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
March 26, 2024Ronald Schutz, Brendan Johnson Named to Forbes Top 200 Lawyers in the United States
-
March 21, 2024Robins Kaplan Firm Members Appointed to Law360 Editorial Boards
-
March 20, 2024Brandon Vaughn Inducted into The International Society of Barristers
-
April 5, 2024Mass Torts Made Perfect
-
April 17, 2024American Antitrust Institute Virtual CLE Lunch & Learn
-
May 2-3, 2024ACI Advanced Forum on Managed Care Disputes and Litigation
-
March 14, 2024How Many Cases Have You Tried to a Verdict?
-
March 2024Do We Have to Share That Information? Attorney-Client Privilege in the Multi-Entity Context
-
March 2024Sellers of a Business: Know Thyself.
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
Read our attorneys' take on the latest news and trends in the legal and business industries.
ANDA Approvals
Fall 2018
Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
---|---|---|---|---|
7/2/2018 | Emtriva | Emtricitabine | Gilead | Cipla |
7/2/2018 | Cancidas | Caspofungin Acetate | Merck | Xellia Pharms |
7/2/2018 | Rythmol SR | Propafenone HCl | GlaxoSmithKline | Wilshire Pharms |
7/2/2018 | Vidaza | Azacitidine | Celgene | Accord Healthcare |
7/2/2018 | Singulair | Montelukast Sodium | Merck Sharp Dohme | Unichem Labs |
7/2/2018 | Xeloda | Capecitabine | Hoffmann La Roche | MSN Labs |
7/2/2018 | Nicorette | Nicotine Polacrilex | GlaxoSmithKline | Watson |
7/2/2018 | Docetaxel | Docetaxel | Hospira | Mylan |
7/2/2018 | Bentyl | Dicyclomine HCl | Allergan | APC Pharms |
7/3/2018 | Plan B One-Step | Levonorgestrel | FDN Consumer | Haupt Pharma |
7/3/2018 | Uceris | Budesonide | Valeant | Actavis Labs FL |
7/3/2018 | Zyprexa Zydis | Olanzapine | Eli Lilly | HEC Pharm |
7/3/2018 | Haldol | Haloperidol Decanoate | Janssen Pharms | Somerset Theraps |
7/5/2018 | Temodar | Temozolomide | Merck Sharp Dohme | Apotex |
7/5/2018 | Zithromax | Azithromycin | Pfizer | Aurobindo |
7/5/2018 | Zithromax | Azithromycin | Pfizer | Aurobindo |
7/5/2018 | Vazculep | Phenylephrine HCl | West Ward Pharm / Avadel Legacy | Amneal |
7/6/2018 | Hepsera | Adefovir Dipivoxil | Gilead | Apotex |
7/6/2018 | Adrenalin | Epinephrine | Par Sterile Products | Luitpold |
7/6/2018 | Plaquenil | Hydroxychloroquine Sulfate | Concordia Pharms | Lupin |
7/6/2018 | Docetaxel | Docetaxel | Hospira | Mylan Labs |
7/9/2018 | Macrodantin | Nitrofurantoin | Alvogen | Novel Labs |
7/9/2018 | Tobi | Tobramycin | Novartis | Dr Reddys |
7/9/2018 | Xanax | Alprazolam | Pharmacia and Upjohn | Centaur Pharms PVT |
7/10/2018 | Bloxiverz | Neostigmine Methylsulfate | Avadel Legacy | Dr Reddys |
7/11/2018 | Namenda | Memantine HCl | Allergan | Apotex |
7/11/2018 | Zomig | Zolmitriptan | IPR | Zydus |
7/11/2018 | Ampyra | Dalfampridine | Acorda | Accord Healthcare |
7/11/2018 | D.H.E. 45 | Dihydroergotamine Mesylate | Valeant | Sagent |
7/11/2018 | Mucinex | Guaifenesin | Reckitt Benckiser | Amneal |
7/12/2018 | Cancidas | Caspofungin Acetate | Merck | Cipla |
7/13/2018 | Oxytocin | Oxytocin | Fresenius Kabi USA & West-Ward Pharms / Par Sterile Products | Sagent |
7/13/2018 | Busulfex | Busulfan | Otsuka Pharm | Mylan |
7/13/2018 | Gleevec | Imatinib Mesylate | Novartis | West-Ward Pharms |
7/13/2018 | Elocon | Mometasone Furoate | Merck Sharp Dohme | Torrent |
7/16/2018 | Angiomax | Bivalirudin | The Medicines Co | Sagent |
7/16/2018 | Welchol | Colesevelam Hydrochloride | Daiichi Sankyo | Glenmark |
7/16/2018 | Glucotorol XL | Glipizide | Pfizer | Zydus |
7/16/2018 | Infumorph / Morphine Sulfate | Mitigo | West-Ward Pharms / Hospira | Piramal Critical |
7/16/2018 | Cleocin T | Clindamycin Phosphate | Pharmacia and Upjohn | Zydus |
7/16/2018 | Vfend | Voriconazole | PF Prism | Zydus |
7/16/2018 | Mucinex | Guaifenesin (OTC) | Reckitt Benckiser | OHM Labs |
7/16/2018 | Dextrose 10% in Plastic Container | Dextrose 10% in Plastic Container | B Braun / Baxter Healthcare / ICU Medical | Fresenius Kabi USA |
7/16/2018 | Minastrin 24 FE | Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | Apil | Chemo Research SL |
7/17/2018 | Zyprexa | Olanzapine | Lilly | Zydus |
7/17/2018 | Feldene | Piroxicam | Pfizer | Zydus |
7/17/2018 | Saphris | Asenapine Maleate | Forest Labs | SigmaPharm Labs |
7/17/2018 | Lidex | Fluocinonide | County Line Pharms | Zydus |
7/18/2018 | Aldactone | Spironolactone | GD Searle | Zydus |
7/19/2018 | Zithromax | Azithromycin | Pfizer | Amneal |
7/19/2018 | Potassium Chloride | Potassium Chloride | Genus LifeSciences | Amneal |
7/19/2018 | Vazculep | Phenylephrine HCl | Avadel Legacy | Amneal |
7/20/2018 | Treximet | Sumatriptan / Naproxen Sodium | Pernix | Sun Pharma |
7/20/2018 | Integrilin | Eptifibatide | Schering | Mylan |
7/20/2018 | Acetadote | Acethylcysteine | Cumberland Pharms | Zydus |
7/20/2018 | Gemcitabine HCl | Gemcitabine HCl | Hospira | Sagent |
7/20/2018 | Cetirizine HCl | Cetirizine HCl | Bionpharma | Aurobindo |
7/20/2018 | Mestinon | Pyridostigmine Bromide | Valeant | Invatech Pharma |
7/23/2018 | Sodium Chloride 0.45% in Plastic Container | Sodium Chloride 0.45% in Plastic Container | B Braun / ICU Medical | Fresenius Kabi USA |
7/23/2018 | Corgard | Nadolol | US WorldMeds | Beximco Pharms |
7/24/2018 | Edecrin | Ethacrynic Acid | Aton | Alvogen |
7/24/2018 | Amrix | Cyclobenzaprine HCl | Teva | Apotex |
7/24/2018 | Cosopt / Cosopt PF | Dorzolamide HCl / Timolol Maleate | Oak Pharms | Aurobindo |
7/25/2018 | Indium in 111 Oxyquinoline | Indium in 111 Oxyquinoline | GE Healthcare | Nordion |
7/25/2018 | Intuniv | Guanfacine HCl | Shire | Apotex |
7/25/2018 | Targretin | Bexarotene | Valeant | Upsher-Smith Labs |
7/27/2018 | Azilect | Rasagiline Mesylate | Teva | Sandoz |
7/27/2018 | Aricept ODT | Donepezil HCl | Eisai | Hisun Pharm Hangzhou |
7/27/2018 | Angiomax | Bivalirudin | The Medicines Co | Aurobindo |
7/27/2018 | Aubagio | Teriflunomide | Sanofi Aventis | Watson |
7/27/2018 | Solaraze | Diclofenac Sodium | Fougera Pharms | Gage Development |
7/30/2018 | Torisel | Temsirolimus | PF Prism | Accord Healthcare |
7/30/2018 | Ampyra | Dalfampridine | Acorda | Alkem Labs |
7/31/2018 | Busulfex | Busulfan | Otsuka | Hospira |
7/31/2018 | Viread | Tenofovir Disoproxil Fumarate | Gilead Sciences | Apotex |
7/31/2018 | Singulair | Montelukast Sodium | Merck | Torrent |
7/31/2018 | Zithromax | Azithromycin | Pfizer | Zydus |
8/15/2018 | Minivelle / Climara | Estradiol | Noven / Bayer | Mylan |
8/16/2018 | EpiPen | Epinephrine (Autoinjector) | Mylan | Teva |
8/17/2018 | Taxol | Paclitaxel | HQ Spclt Pharma | Accord Healthcare |
8/17/2018 | Motrin | Ibuprofen | J and J Consumer | Guardian Drug |
8/17/2018 | Locoid | Hydrocortisone Butyrate | Precision Dermat | Lupin |
8/20/2018 | Zantac 150 | Ranitidine HCl | Sanofi | Granules India |
8/21/2018 | Motrin IB | Ibuprofen | J and J Consumer | Aiping Pharm |
8/21/2018 | Precedex | Dexmedetomidine HCl | Hospira | Baxter |
8/21/2018 | Aggrenox | Aspirin / Dipyridamole | Boehringer Ingelheim | Sun Pharma |
8/21/2018 | Fluocinonide | Fluocinonide | Taro | Amneal |
8/10/2018 | Zosyn | Piperacillin / Tazobactam | Wyeth | Qilu Tianhe |
8/13/2018 | Gleevec | Imatinib Mesylate | Novartis | Dr Reddys Labs |
8/13/2018 | Allegra | Fexofenadine HCl | Sanofi Aventis | Unique Pharm Labs |
8/22/2018 | Truvada | Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Amneal |
8/22/2018 | Bloxiverz | Neostigmine Methylsulfate | Avadel Legacy | Renaissance SSA |
8/24/2018 | Neurontin | Gabapentin | Pfizer | Lupin |
8/24/2018 | Sporanox | Itraconazole | Janssen | Torrent |
8/24/2018 | Docetaxel | Docetaxel | Hospira | Cipla |
8/27/2018 | Glucophage | Metformin HCl | Bristol-Myers Squibb | Laurus Labs |
8/28/2018 | Lopid | Gemfibrozil | Pfizer | Zydus |
8/28/2018 | Tricor | Fenofibrate | AbbVie | Prinston |
8/29/2018 | Combivir | Lamivudine / Zidovudine | ViiV Healthcare | MacLeods |
8/29/2018 | Potassium Chloride | Potassium Chloride | Genus LifeSciences | Novel Labs |
8/30/2018 | Cardizem CD | Diltiazem HCl | Valeant | TWi Pharms |
8/30/2018 | Sustiva | Efavirenz | Bristol-Myers Squibb | Aurobindo |
8/30/2018 | Azor | Amlodipine / Olmesartan Medoxomil | Daiichi Sankyo | Accord Healthcare |
8/31/2018 | Lomotil | Diphenoxylate HCl / Atropine Sulfate | GD Searle | Upsher-Smith Labs |
8/31/2018 | Klor-Con | Potassium Chloride | Upsher-Smith Labs | Strides |
9/4/2018 | Treximet | Sumatriptan / Naproxen Sodium | Pernix | Mylan |
9/4/2018 | Atripla | Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead Sciences | Aurobindo |
9/4/2018 | Brilinta | Ticagrelor | AstraZeneca | Watson |
9/4/2018 | Aubagio | Teriflunomide | Sanofi Aventis | Teva |
9/4/2018 | Targretin | Bexarotene | Valeant | Amneal |
9/5/2018 | Imodium Multi-Symptom Relief | Loperamide HCl / Simethicone | J and J Consumer | Perrigo |
9/7/2018 | Combivir | Lamivudine / Zidovudine | ViiV Healthcare | Cipla |
9/7/2018 | Sandostatin | Octreotide Acetate | Novartis | USV North America |
9/10/2018 | Glucophage XR | Metformin HCl | Bristol-Myers Squibb | Prinston |
9/10/2018 | Magnesium Sulfate In Dextrose 5% Plastic Container | Magnesium Sulfate In Dextrose 5% Plastric Container | Hospira | Mylan |
9/10/2018 | Yasmin | Drospirenone / Ethinyl Estradiol | Bayer | Cyndea Pharma |
9/11/2018 | Atelvia | Risedronate Sodium | Apil | Zydus |
9/11/2018 | Mepron | Atovaquone | GlaxoSmithKline | Lupin |
9/11/2018 | BICNU | Carmustine | Emcure Pharms | Navinta |
9/14/2018 | Inspra | Eplerenone | GD Searle | Breckenridge |
9/14/2018 | Magnesium Sulfate in Plastic Container | Magnesium Sulfate in Plastic Container | Hospira | Mylan |
9/14/2018 | Vagifem | Estradiol | Novo Nordisk | Glenmark |
9/14/2018 | Clolar | Clofarabine | Genzyme | Ingenus Pharms |
9/17/2018 | Norvir | Ritonavir | AbbVie | Hetero Labs |
9/17/2018 | Norvir | Ritonavir | AbbVie | Aurobindo |
9/17/2018 | Norvir | Ritonavir | AbbVie | Amneal |
9/18/2018 | Plan B One-Step | Levonorgestrel | FDN Consumer | Apotex |
9/18/2018 | Achromycin V | Tetracycline HCl | Heritage Pharma | Amneal |
9/19/2018 | Aloxi | Palonosetron HCl | Helsinn | Sagent |
9/19/2018 | Aloxi | Palonosetron HCl | Helsinn | Qilu Pharm |
9/19/2018 | Aloxi | Palonosetron HCl | Helsinn | Sagent |
9/19/2018 | Abilify | Aripiprazole | Otsuka | Mylan |
9/19/2018 | Aloxi | Palonosetron HCl | Helsinn | Cipla |
9/19/2018 | Aloxi | Palonosetron HCl | Helsinn | Mylan |
9/19/2018 | Aloxi | Palonosetron HCl | Helsinn | Fresenius Kabi USA |
9/19/2018 | Aloxi | Palonosetron HCl | Helsinn | Fresenius Kabi USA |
9/19/2018 | Aloxi | Palonosetron HCl | Helsinn | Hospira |
9/19/2018 | Focalin | Dexmethylphenidate HCl | Novartis | Cediprof |
9/19/2018 | Aloxi | Palonosetron HCl | Helsinn | Virtus Pharm |
9/21/2018 | Sustiva | Efavirenz | Bristol-Myers Squibb | Aurobindo Pharma |
9/21/2018 | Albenza | Albendazole | Impax Labs | Cipla |
9/24/2018 | Zithromax | Azithromycin | Pfizer | CSPC Ouyi Pharm |
9/24/2018 | Reyataz | Atazanavir Sulfate | Bristol-Myers Squibb | Mylan |
9/24/2018 | Skelaxin | Metaxalone | King Pharms | Appco Pharma |
9/24/2018 | Zyprexa | Olanzapine | Eli Lilly | Jiangsu Hansoh Pharm |
9/24/2018 | Vibramycin | Doxycycline Hyclate | Pfizer | Ajanta Pharma |
9/24/2018 | Glucophage XR | Metformin HCl | Bristol-Myers Squibb | Yichang Humanwell |
9/26/2018 | Children's Motrin | Ibuprofen | J and J Consumer | Guardian Drug |
9/28/2018 | Lovenox (Preservative Free) | Enoxaparin Sodium | Sanofi Aventis | Apotex |
9/28/2018 | Solodyn | Minocycline HCl | Medicis | Aurobindo Pharma |
9/28/2018 | Avelox | Moxifloxacin HCl | Bayer | Sunshine Lake |
9/28/2018 | Lidex | Fluocinonide | Cnty Line Pharms | Teligent Pharma |
9/28/2018 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Alignscience Pharma |
9/28/2018 | Aubagio | Teriflunomide | Sanofi Aventis | Amneal |
GENERICally Speaking Fall 2018
Related Professionals
Christopher A. Pinahs
Partner
Related Publications
Fourth Quarter
GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Oren Langer, Christopher Pinahs, Emily Tremblay, and Christine May
December 29, 2023
Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc.
GENERICally Speaking Hatch Waxman Bulletin
December 13, 2023
Acadia Pharms. Inc. v. Aurobindo Pharma Ltd.
GENERICally Speaking Hatch Waxman Bulletin
December 7, 2023
H. Lundbeck A/S v. Lupin Ltd.
GENERICally Speaking Hatch Waxman Bulletin
November 7, 2023
Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc.
GENERICally Speaking Hatch Waxman Bulletin
Related News
October 14, 2022
September 9, 2022
Back to Top
Any information that you send us in an e-mail message should not be confidential or otherwise privileged information. Sending us an e-mail message will not make you a client of Robins Kaplan LLP. We do not accept representation until we have had an opportunity to evaluate your matter, including but not limited to an ethical evaluation of whether we are in a conflict position to represent you. Accordingly, the information you provide to us in an e-mail should not be information for which you would have an expectation of confidentiality.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.