- 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
-
October 10, 2024Michael Collyard and Ronald Schutz Named to Minnesota Lawyer’s Power 30: Business Litigation List
-
October 9, 2024Michael Geibelson Named to Daily Journal’s Top Trade Secrets Lawyers
-
October 8, 2024Robins Kaplan Partners Named Women Worth Watching in Leadership
-
October 20, 2024License Agreement Disputes:
-
October 21, 2024How Much Did We Invest in AI?
-
October 22, 2024Justice for All: Minnesota's Civil Legal Aid and Pro Bono Landscape
-
September 2024Meet Our New Partner and Trial Advocacy Seminar Keynote Speaker: B. Todd Jones
-
September 2024Q&A with Alan Harter, Founder of Pactolus Private Wealth Management
-
August 2024Recruiting & Retaining Diverse Attorneys: Building an Inclusive Legal Profession
-
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
New Drug Applications and 505(b)(2) Applications
First Quarter
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 | ANDA Holder | ANDA Applicant |
---|---|---|---|---|
1/3/2023 | Depo-Medrol | Methylprednisolone Acetate | Pfizer | Slayback |
1/4/2023 | Toviaz | Fesoterodine Fumarate | Pfizer | Ani Pharms |
1/4/2023 | Toviaz | Fesoterodine Fumarate | Pfizer | Actavis |
1/4/2023 | Toviaz | Fesoterodine Fumarate | Pfizer | Alembic |
1/4/2023 | Toviaz | Fesoterodine Fumarate | Pfizer | Amneal |
1/4/2023 | Toviaz | Fesoterodine Fumarate | Pfizer | Accord Healthcare |
1/5/2023 | Toviaz | Fesoterodine Fumarate | Pfizer | Lupin |
1/5/2023 | Vimpat | Lacosamide | UCB | Actavis |
1/5/2023 | Vimpat | Lacosamide | UCB | Aurobindo |
1/5/2023 | Depo-Provera | Medroxyprogesterone Acetate | Pfizer | Hikma |
1/5/2023 | Retin-A | Tretinoin | Bausch | Taro Pharms |
1/5/2023 | Permitil | Fluphenazine HCl | Schering | Ajanta Pharma |
1/5/2023 | Jevtana Kit | Cabazitaxel | Sanofi | Sandoz |
1/6/2023 | Fetzima | Levomilnacipran HCl | AbbVie | Aurobindo |
1/6/2023 | Briviact | Brivaracetam | UCB | Aurobindo |
1/6/2023 | Nor-QD | Emzahh | Teva | Aurobindo |
1/9/2023 | Uloric | Febuxostat | Takeda | Zydus |
1/9/2023 | Effient | Prasugrel | Eli Lilly | Lupin |
1/9/2023 | Orfadin | Nitisinone | Swedish Orphan | Torrent |
1/9/2023 | Wellbutrin SR | Bupropion HCl | GlaxoSmithKline | Yichang Humanwell |
1/10/2023 | Glumetza | Metformin HCl | Bausch | Micro Labs |
1/10/2023 | Rexulti | Brexpiprazole | Otsuka | Zydus |
1/10/2023 | Naproxen | Naproxen Sodium | Bionpharma | Patheon Softgels |
1/10/2023 | Arranon | Nelarabine | Novartis | Kindos |
1/11/2023 | Phenylephrine HCl | Phenylephrine HCl | Akorn | Mankind |
1/12/2023 | Restasis | Cyclosporine | AbbVie | Apotex |
1/12/2023 | Infumorph | Morphine Sulfate | Hikma | Hikma |
1/12/2023 | Hetlioz | Tasimelteon | Vanda | MSN |
1/13/2023 | Ketalar | Ketamine HCl | Par | Fresenius Kabi |
1/13/2023 | Rykindo | Risperidone | Luye Pharma | Luye Pharma |
1/17/2023 | Celestone Soluspan | Betamethasone Acetate / Betamethasone Sodium Phosphate | Organon | Hikma |
1/18/2023 | Welchol | Colesevelam HCl | Cosette | Impax |
1/18/2023 | Unithroid | Levothyroxine Sodium | Amneal | Ascent Pharms |
1/18/2023 | Neurontin | Gabapentin | Pfizer | Rubicon |
1/18/2023 | Remeron | Mirtazapine | Organon | Prasco |
1/18/2023 | Benicar | Olmesartan Medoxomil | Cosette | MSN |
1/19/2023 | Imitrex | Sumatriptan Succinate | Glaxo | Baxter Healthcare |
1/19/2023 | Nasacort | Triamcinolone Acetonide | Sanofi | Apotex |
1/19/2023 | Rapamune | Sirolimus | Pfizer | MSN |
1/20/2023 | Nebupent | Pentamidine Isethionate | Fresenius Kabi | X-Gen Pharms Inc |
1/23/2023 | Primacor | Milrinone Lactate | Sanofi | Shandong |
1/23/2023 | Metrogel | Metronidazole | Galderma Labs | Cosette |
1/23/2023 | Adderall XR | Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate | Takeda | Granules |
1/24/2023 | Duragesic-100 | Fentanyl-100 | Janssen | Zydus Noveltech Inc |
1/24/2023 | Duragesic-12 | Fentanyl-12 | Janssen | Zydus Noveltech Inc |
1/24/2023 | Duragesic-25 | Fentanyl-25 | Janssen | Zydus Noveltech Inc |
1/24/2023 | Duragesic-37 | Fentanyl-37 | Janssen | Zydus Noveltech Inc |
1/24/2023 | Duragesic-50 | Fentanyl-50 | Janssen | Zydus Noveltech Inc |
1/24/2023 | Duragesic-75 | Fentanyl-75 | Janssen | Zydus Noveltech Inc |
1/24/2023 | Paraflex | Chlorzoxazone | Ortho McNeil | Belcher |
1/24/2023 | Ketalar | Ketamine HCl | Par | Gland Pharma Ltd |
1/24/2023 | Entereg | Alvimopan | Merck | Par Pharm |
1/25/2023 | Chantix | Varenicline Tartrate | PF Prism | Apotex |
1/26/2023 | Zytiga | Abiraterone Acetate | Janssen | Teva |
1/26/2023 | Cysteine HCl | Cysteine HCl | Hospira | Nivagen Pharms |
1/26/2023 | Imodium | Loperamide HCl | Johnson & Johnson | Rubicon |
1/27/2023 | Paraflex | Chlorzoxazone | Ortho McNeil | Appco |
1/27/2023 | Capoten | Captopril | Strides | Changzhou Pharm |
1/27/2023 | Triamcinolone Acetonide | Triamcinolone Acetonide | Padagis | Glasshouse Pharms |
1/30/2023 | Theophylline | Theophylline | Akorn | Leading |
1/30/2023 | Cubicin | Daptomycin | Merck | Xellia |
1/31/2023 | Levetiracetam In Sodium Chloride | Levetiracetam In Sodium Chloride | HQ Specialty Pharma | Fresenius Kabi USA |
1/31/2023 | Bacteriostatic Water for Injection | Sterile Water For Injection | Hospira | Hikma |
1/31/2023 | Rexulti | Brexpiprazole | Otsuka | Amneal |
2/1/2023 | Nebcin | Tobramycin Sulfate | Eli Lilly | Hainan Poly |
2/2/2023 | Vfend | Voriconazole | PF Prism | Eugia Pharma |
2/2/2023 | Quelicin | Succinylcholine Chloride | Hospira | Mankind |
2/3/2023 | Pennsaid 2% | Diclofenac Sodium | Horizon | Aurolife Pharma |
2/3/2023 | Rexulti | Brexpiprazole | Otsuka | Ajanta Pharma |
2/6/2023 | Vinpat | Lacosamide | UCB | Medley Pharms |
2/7/2023 | Linzess | Linaclotide | AbbVie | Aurobindo |
2/7/2023 | Robinul | Glycopyrrolate | Hikma | Lupin |
2/7/2023 | Aggrastat | Tirofiban HCl | Medicure | Nexus Pharms |
2/8/2023 | Revlimid | Lenalidomide | Celgene | Sun Pharm |
2/8/2023 | Fentanyl Citrate | Fentanyl Citrate | Exela | Exela |
2/9/2023 | Rozerem | Ramelteon | Takeda | Micro Labs |
2/9/2023 | Vimpat | Lacosamide | UCB | MSN |
2/9/2023 | Trokendi XR | Topiramate | Supernus | Zydus |
2/9/2023 | Protonix | Pantoprazole Sodium | Wyeth | Ajanta Pharma |
2/10/2023 | Jevtana Kit | Cabazitaxel | Sanofi | Dr Reddys |
2/10/2023 | Jevtana Kit | Cabazitaxel | Sanofi | Apotex |
2/13/2023 | Iressa | Gefitinib | AstraZeneca | Qilu Pharm Hainan |
2/13/2023 | Alesse | Levonorgestrel / Ethinyl Estradiol | Cadence | Hetero Labs |
2/13/2023 | Apresoline | Hydralazine HCl | Novartis | Eugia Pharma |
2/13/2023 | Hemabate | Carboprost Tromethamine | Pfizer | Caplin |
2/14/2023 | Treanada | Bendamustine HCl | Teva | Breckenridge |
2/14/2023 | Tamiflu | Oseltamivir Phosphate | Roche | Epic Pharma |
2/15/2023 | Rapamune | Sirolimus | Johnson & Johnson | Zydus |
2/15/2023 | Magnesium Sulfate In Plastic Container | Magnesium Sulfate In Plastic Container | Hospira | Amneal |
2/17/2023 | Revlimid | Lenalidomide | Celgene | Torrent |
2/17/2023 | Sinequan | Doxepin HCl | Pfizer | Teva |
2/17/2023 | Bloxiverz | Neostigmine Methylsulfate | Exela | Sagent Pharms |
2/21/2023 | Rythmol SR | Propafenone HCl | GlaxoSmithKline | Aurobindo |
2/22/2023 | Livalo | Pitavastatin Calcium | Kowa | Zydus |
2/22/2023 | Lioresal | Baclofen | Amneal | Rubicon |
2/23/2023 | Cozaar | Losartan Potassium | Organon | Granules |
2/23/2023 | Prevduo | Neostigmine Methylsulfate / Glycopyrrolate | Slayback | Slayback |
2/24/2023 | Benicar HCT | Olmesartan Medoxomil / Hydrochlorothiazide | Cosette | Zydus |
2/24/2023 | Zyprexa | Olanzapine | Eli Lilly | Cadila Pharms |
2/24/2023 | Thiola EC | Tiopronin | Mission | Par |
2/27/2023 | Eliquis | Apixaban | Bristol-Myers Squibb | Zydus |
2/27/2023 | Isovue-M 200 | Iopamidol | Bracco | Hainan Poly |
2/27/2023 | Mexitil | Mexiletine HCl | Boehringer-Ingelheim | Leading |
2/27/2023 | Robinul | Glycopyrrolate | Hikma | Mankind |
2/28/2023 | Zovirax | Acyclovir | Bausch | Zydus |
2/28/2023 | Phenylephrine HCl | Phenylephrine HCl | Hikma | Avet Lifesciences |
2/28/2023 | Advil Dual Action | Acetaminophen / Ibuprofen | GlaxoSmithKline | Perrigo |
2/28/2023 | Ganirelix | Ganirelix Acetate | Merck | Gland Pharma |
2/28/2023 | Taxotere | Docetaxel | Sanofi | Alembic |
3/1/2023 | Trokendi XR | Topiramate | Supernus | Par |
3/1/2023 | Cardizem SR | Diltiazem HCl | Bausch | Twi |
3/1/2023 | Combogesic | Acetaminophen / Ibuprofen | AFT Pharma | AFT Pharma |
3/2/2023 | Avelox | Moxifloxacin HCl | Bayer | Hetero Labs |
3/2/2023 | Viread | Tenofovir Disoproxil Fumarate | Gilead | Reyoung Pharm |
3/2/2023 | Sabril | Vigabatrin | Lundbeck | Zydus |
3/2/2023 | Zemuron | Rocuronium Bromide | Organon | Caplin |
3/2/2023 | Tegretol XR | Carbamazepine | Novartis | Sciecure Pharma |
3/2/2023 | Renvela | Sevelamer Carbonate | Sanofi | Hangzhou Anprime |
3/3/2023 | Arranon | Nelarabine | Novartis | Shorla |
3/3/2023 | Bicnu | Carmustine | Avet Lifesciences | Myla |
3/3/2023 | Cialis | Tadalafil | Eli Lilly | Novitium Pharma |
3/3/2023 | Fluorouracil | Fluorouracil | Spectrum | Alembic |
3/6/2023 | Revlimid | Lenalidomide | Celgene | Arrow |
3/6/2023 | Pylera | Bismuth Subcitrate Potassium / Metronidazole / Tetracycline HCl | AbbVie | Par |
3/6/2023 | Revlimid | Lenalidomide | Celgene | Zydus |
3/6/2023 | Revlimid | Lenalidomide | Celgene | Cipla |
3/6/2023 | Revlimid | Lenalidomide | Celgene | Lotus Pharm |
3/6/2023 | Revlimid | Lenalidomide | Celgene | Sun Pharm |
3/6/2023 | Revlimid | Lenalidomide | Celgene | Eugia Pharma |
3/6/2023 | Revlimid | Lenalidomide | Celgene | Mylan |
3/6/2023 | Revlimid | Lenalidomide | Celgene | Cipla |
3/6/2023 | Thiamine | Thiamine HCl | Fresenius Kabi | Caplin |
3/6/2023 | Minipress | Prazosin HCl | Pfizer | Alembic |
3/7/2023 | Revlimid | Lenalidomide | Celgene | Apotex |
3/7/2023 | Eryc | Erythromycin | Mayne | Zydus |
3/7/2023 | Gemzar | Gemcitabine HCl | Hospira | Hikma |
3/7/2023 | Potassium Chloride | Potassium Chloride | Genus | Belcher |
3/7/2023 | Cardizem LA | Diltiazem HCl | Bausch | Amta |
3/7/2023 | Narcan | Naloxone | Amphastar | Emergent |
3/8/2023 | Vascepa | Icosapent Ethyl | Amarin | Dr Reddys |
3/8/2023 | Zyrtec-D 12 Hour | Cetirizine HCl / Pseudoephedrine HCl | Johnson & Johnson | Aurobindo |
3/8/2023 | Naropin | Ropivacaine HCl | Fresenius Kabi USA | Amneal |
3/8/2023 | Pepcid AC | Famotidine | Johnson & Johnson | Marksans Pharma |
3/9/2023 | Zyprexa | Olanzapine | Eli Lilly | Zydus |
3/9/2023 | VFend | Voriconazole | PF Prism | UBI |
3/9/2023 | Truvada | Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Aurobindo |
3/9/2023 | Emerphed | Ephedrine Sulfate | Nexus | Sagent |
3/9/2023 | Zovirax | Acyclovir | Mylan | MSN |
3/10/2023 | Alimta | Pemetrexed Disodium | Eli Lilly | Mylan |
3/10/2023 | Trokendi XR | Topiramate | Supernus | Actavis |
3/10/2023 | Latuda | Lurasidone HCl | Sunovion | Aurobindo |
3/10/2023 | Advil Cold and Sinus | Ibuprofen / Pseudoephedrine HCl | GlaxoSmithKline | Aurobindo |
3/10/2023 | Colestid | Colestipol HCl | Pfizer | Praxgen |
3/10/2023 | Cleocin | Clindamycin HCl | Pfizer | Glenmark |
3/13/2023 | Aubagio | Teriflunomide | Sanofi | Hetero Labs |
3/13/2023 | Aubagio | Teriflunomide | Sanofi | Biocon Pharma |
3/13/2023 | Xeljanz | Tofacitinib Citrate | Pfizer | Micro Labs |
3/13/2023 | PhosLo GelCaps | Calcium Acetate | Fresenius | Square |
3/14/2023 | Xeljanz | Tofacitinib Citrate | Pfizer | Zydus |
3/15/2023 | Emtriva | Emtricitabine | Gilead | Aurobindo |
3/15/2023 | Lovenox | Enoxaparin Sodium | Sanofi | Shenzhen Techdow |
3/15/2023 | Cataflam | Diclofenac Potassium | Amici | Senores Pharms |
3/15/2023 | Nexium 24Hr | Esomeprazole Magnesium | AstraZeneca | Guardian Drug |
3/15/2023 | Duexis | Ibuprofen / Famotidine | Horizon | Ascent Pharms |
3/15/2023 | Gadavist | Gadobutrol | Bayer | Hainan Poly |
3/16/2023 | Ranexa | Ranolazine | Gilead | Unichem |
3/17/2023 | Prednisolone | Prednisolone | Watson | Aurobindo |
3/17/2023 | Compazine | Prochlorperazine Maleate | Glaxo | Glenmark |
3/18/2023 | Rexulti | Brexpiprazole | Otsuka | Lupin |
3/20/2023 | Fetzima | Levomilnacipran HCl | AbbVie | Prinston |
3/20/2023 | Tazorac | Tazarotene | AbbVie | Solaris Pharma |
3/20/2023 | Theo-Dur | Theophylline | Schering | Amneal |
3/20/2023 | Anafranil | Clomipramine HCl | SpecGX | Aurobindo |
3/20/2023 | DDAVP | Desmopressin Acetate | Ferring | Gland |
3/21/2023 | Sinequan | Doxepin HCl | Pfizer | Zydus |
3/21/2023 | Enstillar | Calcipotriene / Betamethasone Dipropionate | Leo | Glenmark |
3/21/2023 | Macrodantin | Nitrofurantoin | Almatica | Mankind |
3/22/2023 | Prandin | Repaglinide | Gemini Labs | Macleods |
3/22/2023 | Perforomist | Formoterol Fumarate | Mylan | Mankind |
3/22/2023 | Zyprexa | Olanzapine | Lilly | Aspiro |
3/23/2023 | Sinequan | Doxepin HCl | Pfizer | Zydus |
3/23/2023 | Timoptic-XE | Timolol Maleate | Bausch | Eugia |
3/23/2023 | Amitiza | Lubiprostone | Sucampo | Zydus |
3/23/2023 | Zytiga | Abiraterone Acetate | Johnson & Johnson | Florida |
3/23/2023 | Loperamide HCl | Loperamide HCl | Bionpharma | Zydus |
3/24/2023 | Claritin | Loratadine | Bayer | Aurobindo |
3/24/2023 | Amicar | Aminocaproic Acid | Akorn | Taro |
3/24/2023 | Tegretol XR | Carbamazepine | Novartis | Ajanta |
3/24/2023 | Bentyl | Dicyclomine HCl | Allergan | Corepharma |
3/24/2023 | Levothyroxine | Levothyroxine Sodium | Fresenius Kabi | Zydus |
3/28/2023 | Prevacid ODT | Lansoprazole | Takeda | Aurobindo |
3/28/2023 | Nexium | Esomeprazole Magnesium | AstraZeneca | Prinston |
3/28/2023 | Xylocaine Viscous | Lidocaine HCl | Fresenius Kabi | Rubicon |
3/28/2023 | Neurontin | Gabapentin | Viatris | Granules |
3/29/2023 | Climara | Estradiol | Bayer | Zydus |
3/29/2023 | Lyrica | Pregabalin | Upjohn | Aurobindo |
3/29/2023 | Alphagan P | Brimonidine Tartrate | AbbVie | Alembic |
3/29/2023 | Cardizem | Diltiazem HCl | Biovail Labs | Eugia Pharma |
3/30/2023 | Tradjenta | Linagliptin | Boehringer-Ingelheim | Zydus |
3/30/2023 | Jentadueto | Linagliptin / Metformin HCl | Boehringer-Ingelheim | Zydus |
3/30/2023 | Macrobid | Nitrofurantoin (Monohydrate / Macrocrystals) | Almatica | Aurobindo |
3/30/2023 | Vemlidy | Tenofovir Alafenamide | Gilead | Lupin |
3/30/2023 | Prolixin Decanoate | Fluphenazine Decanoate | Bristol-Myers Squibb | Gland Pharma |
3/30/2023 | Bystolic | Nebivolol HCl | AbbVie | Beximco Pharms |
3/31/2023 | Minipress | Prazosin HCl | Pfizer | Aurobindo |
3/31/2023 | Apriso | Mesalamine | Bausch | Aurobindo |
GENERICally Speaking Hatch Waxman Bulletin
GENERICally Speaking Hatch Waxman Bulletin
READ MORE Related Publications
Second Quarter
GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Oren Langer, Christopher Pinahs, Emily Tremblay, and Christine May
June 25, 2024
Amarin Pharma, Inc. v. Hikma Pharms. USA Inc.
GENERICally Speaking Hatch Waxman Bulletin
June 10, 2024
Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC
GENERICally Speaking Hatch Waxman Bulletin
April 30, 2024
Pharmacyclics LLC v. Alvogen Pine Brook LLC
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Oren Langer, Christopher Pinahs, Emily Tremblay, and Christine May
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.