- 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
-
November 20, 2024Eighth Circuit Affirms U.S. Merchants Victory in Trade Dress Infringement Case
-
November 15, 2024Lauren Coppola Named an Emerging Leader by Profiles in Diversity Journal
-
November 11, 2024Tommy Du Honored With 2024 Sheila Sonenshine Associate Pro Bono Award
-
December 3, 2024Can You Keep a Secret? Privacy Laws and Civil Litigation
-
December 11, 20242024 Year in Review: eDiscovery and Artificial Intelligence
-
December 12, 2024Strategies for Licensing AI: A Litigation Perspective
-
November 8, 2024Trademark tensions on the track: Court upholds First Amendment protections in Haas v. Steiner
-
November 8, 2024Destination Skiing And The DOJ's Mountain Merger Challenge
-
November 6, 2024How Recent Patent Damages Precedent May Increase Reasonable Royalty Awards
-
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.
New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Fall 2020
This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings before the Patent Trial and Appeal Board concerning Orange Book-listed patents.
| Case Name | Date Filed | Judge | Drug | Patent No(s). |
|---|---|---|---|---|
| Avion Pharms., LLC v. Granules Pharms., Inc., 20-0898 (D. Del.) | July 1, 2020 | Hon. Leonard P. Stark | Gloperba® (colchicine oral solution) |
9,907,751 10,226,423 |
| Horizon Medicines LLC v. Teva Pharms. USA, Inc., 20-8188 (D.N.J.) | July 2, 2020 | Hon. John M. Vazquez | Duexis® (ibuprofen / famotidine tablets) |
8,067,033 8,067,451 8,309,127 8,318,202 8,449,910 8,501,228 |
| Vifor Fresenius Medical Care Renal Pharma Ltd. v. Lupin Atlantis Holdings SA, 20-0911 (D. Del.) | July 6, 2020 | Hon. Maryellen Noreika | Velphoro® (sucroferric oxyhydroxide chewable tablets) |
10,682,376 10,695,367 |
| Arbor Pharms., LLC v. Lupin Ltd., 20-0922 (D. Del.) | July 8, 2020 | Hon. Maryellen Noreika | Edarbi® (azilsartan medoxomil tablets) | 7,157,584 7,572,920 9,066,936 |
| Allergan, Inc. v. Gland Pharma Ltd., 20-0932 (D. Del.) | July 9, 2020 | Hon. Colm F. Connolly | Lastacaft® (alcaftadine ophthalmic solution) | 8,664,215 10,617,695 |
| Celgene Corp. v. Lupin Ltd., 20-8570 (D.N.J.) | July 9, 2020 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,465,800 7,855,217 7,968,569 8,530,498 8,648,095 9,101,621 9,101,622 |
| Allergan, Inc. v. Gland Pharma Ltd., 20-4094 (N.D. Ill.) | July 10, 2020 | Hon. Joan B. Gottschall | Lastacaft® (alcaftadine ophthalmic solution) | 8,664,215 10,617,695 |
| TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 20-8809 (D.N.J.) | July 13, 2020 | Hon. Brian R. Martinotti | Imvexxy® (estradiol vaginal inserts) |
10,537,581 |
| Amarin Pharma, Inc. v. Hikma Pharms. USA, Inc., 20-0421 (D. Nev) | July 13, 2020 | Hon. Miranda M. Du | Vascepa® (icosapent ethyl capsules) |
8,293,728 8,318,715 8,357,677 8,367,652 8,377,920 8,415,335 8,426,399 8,440,650 8,518,929 8,524,698 8,546,372 8,617,594 |
| Merck Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., 20-0949 (D. Del.) | July 15, 2020 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
| Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc., 20-8966 (D.N.J.) | July 15, 2020 | Hon. Stanley R. Chesler | Vyvanse® (lisdexamfetamine dimesylate capsules) | 7,105,486 7,223,735 7,655,630 7,659,253 7,659,254 7,662,787 7,662,788 7,671,030 7,671,031 7,674,774 7,678,770 7,678,771 7,687,466 7,687,467 7,700,561 7,713,936 7,718,619 7,723,305 |
| Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc., 20-0953 (D. Del.) | July 16, 2020 | Hon. Leonard P. Stark | Vyvanse® (lisdexamfetamine dimesylate capsules) | 7,105,486 7,223,735 7,655,630 7,659,253 7,659,254 7,662,787 7,662,788 7,671,030 7,671,031 7,674,774 7,678,770 7,678,771 7,687,466 7,687,467 7,700,561 7,713,936 7,718,619 7,723,305 |
| Cephalon, Inc. v. Aurobindo Pharma, Ltd., 20-0962 (D. Del.) | July 17, 2020 | Hon. Colm F. Connolly | Treanda® (bendamustine HCL for injection) | 8,436,190 8,609,863 8,791,270 8,895,756 |
| AbbVie Inc. v. Dr. Reddy’s Labs., Ltd., 20-0968 (D. Del.) | July 21, 2020 | Hon. Leonard P. Stark | Venclexta® (venetoclax tablets) |
8,546,399 9,174,982 8,722,657 9,539,251 |
| Almirall, LLC v. Perrigo UK Finco Ltd. Partnership, 20-0975 (D. Del.) | July 22, 2020 | Hon. Gerald J. Pappert | Aczone® (dapsone gel) |
9,517,219 |
| ViiV Healthcare Co. v. Cipla Ltd., 20-0977 (D. Del.) | July 22, 2020 | Hon. Mitchell S. Goldberg | Juluca® (dolutegravir sodium / rilpivirine HCl tablets) | 9,242,986 10,426,780 |
| AbbVie Inc. v. Dr. Reddy’s Labs., Inc., 20-9292 (D.N.J.) | July 22, 2020 | Hon. Michael A. Shipp | Venclexta® (venetoclax tablets) |
8,546,399 9,174,982 8,722,657 9,539,251 |
| Pfizer Inc. v. Novo Nordisk A/S, IPR2020-01252 (PTAB) | July 22, 2020 | N/A | Victoza® (liraglutide recombinant for injection) Saxenda® (liraglutide recombinant for injection) Ozempic® (semaglutide for injection) | 8,114,833 |
| Janssen Products, L.P. v. Evenus Pharms. Labs. Inc., 20-9369 (D.N.J.) | July 23, 2020 | Hon. Freda L. Wolfson | Yondelis® (trabectedin for injection) | 8,895,557 |
| ACADIA Pharms. Inc. v. Aurobindo Pharma Ltd., 20-0985 (D. Del.) | July 24, 2020 | Hon. Richard G. Andrews | Nuplazid® (pimavanserin tartrate capsules) | 7,601,740 7,732,615 10,449,185 10,646,480 |
| ACADIA Pharms. Inc. v. Teva Pharms. USA, Inc., 20-0986 (D. Del.) | July 24, 2020 | Hon. Richard G. Andrews | Nuplazid® (pimavanserin tartrate capsules) | 7,601,740 7,732,615 10,449,185 10,646,480 |
| UCB, Inc. v. Annora Pharma Private Ltd., 20-0987 (D. Del.) | July 24, 2020 | Hon. Colm F. Connolly | Briviact® (brivaracetam tablets) |
6,784,197 6,911,461 8,492,416 |
| Vertex Pharms. Inc. v. Sun Pharm. Indus. Ltd., 20-0988 (D. Del.) | July 24, 2020 | Hon. Richard G. Andrews | Kalydeco® (ivacaftor tablets) |
10,646,481 |
| AbbVie Inc. v. Alembic Pharms. Ltd., 20-1009 (D. Del.) | July 28, 2020 | Hon. Leonard P. Stark | Venclexta® (venetoclax tablets) |
8,546,399 9,174,982 8,722,657 9,539,251 |
| ACADIA Pharms. Inc. v. Zydus Pharms. (USA) Inc., 20-1021 (D. Del.) | July 30, 2020 | Hon. Richard G. Andrews | Nuplazid® (pimavanserin tartrate capsules) | 7,601,740 7,732,615 10,517,860 10,449,185 10,646,480 |
| ACADIA Pharms. Inc. v. Hetero Labs Ltd., 20-1022 (D. Del.) | July 30, 2020 | Hon. Richard G. Andrews | Nuplazid® (pimavanserin tartrate capsules) | 7,601,740 10,449,185 10,646,480 |
| ACADIA Pharms. Inc. v. MSN Labs. Private Ltd., 20-1029 (D. Del.) | July 30, 2020 | Hon. Richard G. Andrews | Nuplazid® (pimavanserin tartrate capsules) | 7,732,615 10,646,480 |
| Teva Branded Pharm. Products R&D, Inc. v. Cipla Ltd., 20-10172 (D.N.J.) | Aug. 7, 2020 | Hon. Madeline Cox Arleo | Qvar® (beclomethasone dipropionate metered aerosol) | 9,463,289 9,808,587 10,022,509 10,022,510 10,086,156 10,561,808 |
| Allergan Pharms. Int’l Ltd. v. Sun Pharm. Indus. Ltd., 20-10176 (D.N.J.) | Aug. 7, 2020 | Hon. Susan D. Wigenton | Asacol® (mesalamine delayed-release tablets) | 9,089,492 |
| Biocon Pharma Ltd. v. Novartis Pharms. Corp., IPR2020-01263 (PTAB) | Aug. 7, 2020 | N/A | Entresto® (sacubitril / valsartan tablets)) | 8,101,659 |
| Horizon Orphan LLC v. Lupin Ltd., 20-10339 (D.N.J.) | Aug. 11, 2020 | Hon. Madeline Cox Arleo | Procysbi® (cysteamine bitartrate delayed-release capsules) |
8,026,284 9,192,590 9,198,882 9,925,156 9,925,157 9,925,158 9,173,851 9,233,077 10,143,665 10,328,037 10,548,859 |
| Bayer Intellectual Property GmbH v. Dr. Reddy’s Labs., Inc., 20-10378 (D.N.J.) | Aug. 12, 2020 | Hon. Madeline Cox Arleo | Xarelto® (rivaroxaban tablets) | 9,539,218 |
| Currax Pharms. LLC v. MSN Labs. Private Ltd., 20-1064 (D. Del.) | Aug. 13, 2020 | Hon. Richard G. Andrews | Silenor® (doxepin HCl tablets) | 7,915,307 9,532,971 9,572,814 9,907,780 10,548,871 10,653,660 |
| Merck Sharp & Dohme Corp. v. Aurobindo Pharma USA Inc., 20-10444 (D.N.J.) | Aug. 13, 2020 | Hon. Freda L. Wolfson | Noxafil® (posaconazole for injection) | 9,023,790 9,358,297 |
| Adamas Pharma, LLC v. Zydus Worlwide DMCC, 20-10463 (D.N.J.) | Aug. 13, 2020 | Hon. Brian R. Martinotti | Gocovri® (amantadine HCl extended-release capsules) | 8,389,578 8,796,337 8,889,740 8,895,614 8,895,615 8,895,616 8,895,617 8,895,618 8,741,343 9,867,791 9,867,792 9,867,793 9,877,933 10,154,971 10,646,456 |
| Azurity Pharms., Inc. v. Alkem Labs Ltd., 20-1094 (D. Del.) | Aug. 20, 2020 | Hon. Leonard P. Stark | Firvanq® (vancomycin HCl oral solution) | 10,493,028 |
| Merck Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., 20-1099 (D. Del.) | Aug. 21, 2020 | Hon. Richard G. Andrews | Janumet® (metformin HCl / sitagliptin phosphate tablets) | 7,326,708 |
| Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., 20-1104 (D. Del.) | Aug. 21, 2020 | Hon. Colm F. Connolly | Hetlioz® (tasimelteon capsules) |
10,610,510 10,610,511 |
| Intercept Pharms., Inc. v. Apotex Inc., 20-1105 (D. Del.) | Aug. 21, 2020 | Hon. Maryellen Noreika | Ocaliva® (obeticholic acid tablets) |
9,238,673 10,047,117 10,052,337 10,174,073 |
| Bausch Health Ireland Ltd. v. Lupin Ltd., 20-11039 (D.N.J.) | Aug. 21, 2020 | Hon. Renee Marie Bumb | Plenvu® (polyethylene glycol / sodium ascorbate / sodium sulfate / ascorbic acid / sodium chloride / potassium chloride oral solution) | 10,646,512 |
| TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 20-11087 (D.N.J.) | Aug. 21, 2020 | Hon. Brian M. Martinotti | Imvexxy® (estradiol vaginal inserts) | 10,668,082 |
| Assertio Therapeutics, Inc. v. Patrin Pharma, Inc., 20-5055 (N.D. Ill.) | Aug. 27, 2020 | Hon. Charles P. Kocoras | Cambia® (diclofenac potassium powder for oral solution) | 7,759,394 8,097,651 8,927,604 9,827,197 |
| Boehringer Ingelheim Pharms. Inc. v. Sun Pharm. Indus. Ltd., 20-1153 (D. Del.) | Aug. 28, 2020 | Hon. Colm F. Connolly | Trijardy XR® (empagliflozin / linagliptin / metformin extended-release tablets) | 8,551,957 9,155,705 9,415,016 9,949,998 10,022,379 10,258,637 10,406,172 10,596,120 |
| Intercept Pharms., Inc. v. Amneal Pharms. LLC, 20-1154 (D. Del.) | Aug. 28, 2020 | Hon. Maryellen Noreika | Ocaliva® (obeticholic acid tablets) | 9,238,673 10,047,117 10,052,337 10,174,073 |
| Intercept Pharms., Inc. v. Lupin Ltd., 20-1155 (D. Del.) | Aug. 28, 2020 | Hon. Maryellen Noreika | Ocaliva® (obeticholic acid tablets) |
7,138,390 9,238,673 10,047,117 10,052,337 10,174,073 |
| Bausch Health Ireland Ltd. v. Perrigo Israel Pharms. Ltd., 20-11807 (D.N.J.) | Aug. 28, 2020 | Hon. Stanley R. Chesler | Duobrii® (halobetasol propionate / tazarotene lotion) | 8,809,307 10,478,502 10,251,895 10,426,787 |
| Biogen MA Inc. v. Sun Pharm. Indus. Ltd., 20-1159 (D. Del.) | Aug. 31, 2020 | Hon. Maryellen Noreika | Tecfidera® (dimethyl fumarate delayed-release capsules) | 8,399,514 |
| AstraZeneca AB v. Macleods Pharms. Ltd., 20-1180 (D. Del.) | Sept. 3, 2020 | Hon. Richard G. Andrews | Brilinta® (ticagrelor tablets) |
10,300,065 |
| Astellas US LLC v. Meitheal Pharms., Inc., 20-1182 (D. Del.) | Sept. 4, 2020 | Hon. Colm F. Connolly | Lexiscan® (regadenoson for injection) |
8,106,183 RE47,301 8,524,883 |
| Fresenius Kabi USA, LLC v. Gland Pharma Ltd., 20-12347 (D. N.J.) | Sept. 4, 2020 | Hon. Freda L. Wolfson | Naropin® (ropivacaine HCl for injection) |
8,118,802 |
| Alkermes, Inc. v. Teva Pharm. Indus. Ltd., 20-12470 (D.N.J.) | Sept. 9, 2020 | Hon. Madeline Cox Arleo | Vivitrol® (extended-release naltrexone for injection) | 7,919,499 |
| Intercept Pharms., Inc. v. MSN Labs. Private Ltd., 20-1214 (D. Del.) | Sept. 10, 2020 | Hon. Maryellen Noreika | Ocaliva® (obeticholic acid tablets) | 7,138,390 9,238,673 10,047,117 10,052,337 10,174,073 |
| Intercept Pharms., Inc. v. Optimus Pharma Pvt. Ltd., 20-1215 (D. Del.) | Sept. 10, 2020 | Hon. Maryellen Noreika | Ocaliva® (obeticholic acid tablets) | 7,138,390 9,238,673 10,047,117 10,052,337 10,174,073 |
| Orexo AB v. Sun Pharm. Indus. Ltd., 20-12588 (D.N.J.) | Sept. 11, 2020 | Hon. Brian R. Martinotti | Zubsolv® (buprenorphine / naloxone sublingual tablets) | 8,470,361 8,658,198 8,940,330 9,259,421 9,439,900 |
| Merck Sharp & Dohme Corp. v. Unichem Labs. Ltd., 20-1227 (D. Del.) | Sept. 15, 2020 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
| Silvergate Pharms., Inc. v. Amneal Pharms. LLC, 20-1255 (D. Del.) | Sept. 18, 2020 | Hon. Leonard P. Stark | Epaned® (enalapril maleate oral solution) | 10,772,868 |
| Silvergate Pharms., Inc. v. Bionpharma Inc., 20-1256 (D. Del.) | Sept. 18, 2020 | Hon. Leonard P. Stark | Epaned® (enalapril maleate oral solution) | 10,772,868 |
| Kitov Pharma Ltd. v. Lupin Ltd., 20-12849 (D.N.J.) | Sept. 18, 2020 | Hon. Claire C. Cecchi | Consensi® (amlodipine besylate / celecoxib tablets) | 10,350,171 9,408,837 |
| Eton Pharms., Inc. v. Exela Pharma Sciences, LLC, PGR2020-00086 (PTAB) | Sept. 21, 2020 | N/A | Elcys® (cysteine HCl for injection) Nouress® (cysteine HCl for injection) | 10,653,719 |
| Janssen Pharms., Inc. v. Mylan Labs. Ltd., 20-13103 (D.N.J.) |
Sept. 23, 2020 | Hon. Brian R. Martinotti | Trinza® (paliperidone palmitate extended-release injectable suspension) | 10,143,693 |
| Otsuka Pharm. Co., Ltd. v. Alkem Labs. Ltd., 20-1286 (D. Del.) |
Sept. 24, 2020 | Hon. Leonard P. Stark | Rexulti® (brexipiprazole tablets) |
RE48,059 |
| Otsuka Pharm. Co., Ltd. v. Accord Healthcare Inc., 20-1287 (D. Del.) |
Sept. 24, 2020 | Hon. Leonard P. Stark | Rexulti® (brexipiprazole tablets) |
RE48,059 |
| Otsuka Pharm. Co., Ltd. v. Accord Healthcare Inc., 20-0878 (M.D.N.C.) |
Sept. 24, 2020 | Hon. Thomas D. Schroeder | Rexulti® (brexipiprazole tablets) |
RE48,059 |
| Otsuka Pharm. Co., Ltd. v. Unichem Labs. Ltd., 20-1295 (D. Del.) |
Sept. 25, 2020 | Hon. Leonard P. Stark | Rexulti® (brexipiprazole tablets) |
RE48,059 |
| Otsuka Pharm. Co., Ltd. v. Lupin Ltd., 20-1296 (D. Del.) |
Sept. 25, 2020 | Hon. Leonard P. Stark | Rexulti® (brexipiprazole tablets) |
RE48,059 |
| Otsuka Pharm. Co., Ltd. v. Amneal Pharms. LLC, 20-1297 (D. Del.) |
Sept. 25, 2020 | Hon. Leonard P. Stark | Rexulti® (brexipiprazole tablets) |
RE48,059 |
GENERICally Speaking Fall 2020
Related Professionals
Christopher A. Pinahs
Partner
GENERICally Speaking Fall 2020
VOL. 10, NO. 3 Related Publications
September 18, 2024
Astellas Pharma, Inc. v. Sandoz Inc.
GENERICally Speaking Hatch Waxman Bulletin
September 9, 2024
Purdue Pharma L.P v. Accord Healthcare Inc.
GENERICally Speaking Hatch Waxman Bulletin
September 4, 2024
Exeltis USA, Inc. v. Lupin Ltd.
GENERICally Speaking Hatch Waxman Bulletin
August 28, 2024
Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S.
GENERICally Speaking Hatch Waxman Bulletin
August 13, 2024
Allergan USA, Inc. v. MSN Labs. Private Ltd.
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.