- 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
Summer 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). |
|---|---|---|---|---|
| TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 20-3485 (D.N.J.) | Apr. 1, 2020 | Hon. Brian R. Martinotti | Imvexxy® (estradiol vaginal inserts) | 9,180,091 9,289,382 10,258,630 10,398,708 10,471,072 |
| Merck Sharp & Dohme B.V. v. Mylan Pharms. Inc., 20-0061 (N.D.W.V.) | Apr. 2, 2020 | Hon. Thomas S. Kleeh | Bridion® (sugammadex for injection) | RE44,733 |
| Chiesi USA, Inc. v. Hikma Pharms. USA Inc., 20-0484 (D. Del.) | Apr. 8, 2020 | Hon. Leonard P. Stark | Ferriprox® (deferiprone tablets) | 7,049,328 |
| Merck Sharp & Dohme B.V. v. Biophore Pharma Inc., 20-3795 (D.N.J.) | Apr. 8, 2020 | Hon. Claire C. Cecchi | Bridion® (sugammadex for injection) | RE44,733 |
| Actelion Pharms. Ltd. v. MSN Pharms. Inc., 20-3859 (D.N.J.) | Apr. 9, 2020 | Hon. Renee Marie Bumb | Uptravi® (selexipag tablets) | 7,205,302 8,791,122 9,284,280 |
| Eisai R&D Management Co., Ltd. v. Sandoz Inc., 20-3895 (D.N.J.) | Apr. 9, 2020 | Hon. Stanley R. Chesler | Halaven® (eribulin mesylate for injection) | RE46,965 |
| Purdue Pharma L.P. v. Intellipharmaceutics Int’l Inc., 20-0515 (D. Del.) | Apr. 15, 2020 | Hon. Richard G. Andrews | OxyContin® (oxycodone HCl extended-release tablets) | 10,407,434 10,369,109 |
| Astellas US LLC v. Glenmark Pharms. Ltd., 20-0516 (D. Del.) | Apr. 15, 2020 | Hon. Colm F. Connolly | Lexiscan® (regadenoson for injection) | 8,106,183
RE 47,301 8,524,883 |
| Pharmacyclics LLC v. Zydus Worldwide DMCC, 20-0560 (D. Del.) | Apr. 24, 2020 | Hon. Colm F. Connolly | Imbruvica® (ibrutinib tablets) | 7,514,444 8,008,309 8,476,284 8,497,277 8,697,711 8,735,403 8,754,090 8,754,091 8,952,015 8,957,079 9,181,257 9,296,753 9,725,455 10,010,507 10,106,548 10,125,140 10,213,386 10,478,439 |
| Tris Pharma, Inc. v. Teva Pharms. USA, Inc., 20-5212 (D.N.J.) | Apr. 28, 2020 | Hon. Kevin McNulty | QuilliChew ER® (methylphenidate HCl extended-release tablets) | 9,545,399 9,844,544 9,844,545 |
| TherapeuticsMD, Inc. v. Amneal Pharms., Inc., 20-5256 (D.N.J.) | Apr. 29, 2020 | Hon. Freda J. Wolfson | Bijuva® (estradiol / progesterone capsules) | 8,633,178 8,846,648 8,846,649 8,987,237 8,993,548 8,993,549 9,006,222 9,114,145 9,114,146 9,301,920 10,052,386 10,206,932 |
| Bausch Health Ireland Ltd. v. Perrigo Israel Pharms. Ltd., 20-5426 (D.N.J.) | 1-May-20 | Hon. Michael A. Shipp | Bryhali® (halobetasol propionate lotion) | 8,809,307 10,478,502 |
| Bayer Intellectual Property Gmbh v. Unichem Inc., 20-5439 (D.N.J.) | 1-May-20 | Hon. Madeline Cox Alreo | Xarelto® (rivaroxaban tablets) | 7,157,456 9,539,218 |
| Genentech, Inc. v. Intermune, Inc., 20-0624 (D. Del.) | 8-May-20 | Hon. Richard G. Andrews | Esbriet® (pirfenidone tablets) | 7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,318,780 8,420,674 8,592,462 8,609,701 |
| Boehringer Ingelheim Pharms. Inc. v. Mylan Pharms. Inc., 20-0090 (N.D.W.V.) | 8-May-20 | Hon. Irene M. Keeley | Jentadueto® (linagliptin / metformin tablets) | 9,415,016 10,022,379 |
| Teva Pharms. Int’l Gmbh v. Aurobindo Pharma, Ltd., 20-0632 (D. Del.) | 11-May-20 | Hon. Colm F. Connolly | Bendeka® (bendamustine HCl injection) | 8,609,707 9,265,831 9,572,796 9,572,797 9,034,908 9,144,568 9,572,887 9,597,397 9,597,398 9,597,399 9,000,021 9,579,384 10,010,533 10,052,385 |
| Exelixis, Inc. v. MSN Labs. Private Ltd., 20-0633 (D. Del.) | 11-May-20 | Hon. Richard G. Andrews | Cabometyx® (cabozantinib tablets) | 7,579,473 8,497,284 |
| Exela Pharma Sciences, LLC v. Sandoz, Inc., 20-0645 (D. Del.) | 14-May-20 | Hon. Maryellen Noreika | Elcys® (cysteine HCl injection) | 10,478,453 10,583,155 |
| Sanofi-Aventis U.S. LLC v. MSN Pharms., Inc., 20-0646 (D. Del.) | 14-May-20 | Hon. Richard G. Andrews | Jevtana® Kit (cabazitaxel injection) | 10,583,110 |
| Exela Pharma Sciences, LLC v. Sandoz, Inc., 20-1393 (D. Col.) | 15-May-20 | Hon. Michael E. Hegarty | Elcys® (cysteine HCl injection) | 10,478,453 10,583,155 |
| Eton Pharms., Inc. v. Exela Pharma Sciences, LLC, PGR2020-00064 (PTAB) | 19-May-20 | N/A | Elcys® (cysteine HCl injection) | 10,478,453 |
| Millennium Pharms., Inc. v. Baxter Healthcare Corp., 20-0682 (D. Del.) | 20-May-20 | Hon. Colm F. Connolly | Velcade® (bortezomib for injection) | 6,713,446 6,958,319 |
| Vifor Fresenius Medical Care Renal Pharma Ltd. v. Lupin Atlantis Holdings SA, 20-0697 (D. Del.) | 26-May-20 | Hon. Maryellen Noreika | Velphoro® (sucroferric oxyhydroxide chewable tablets) | 10,624,855 |
| Boehringer Ingelheim Pharms. Inc. v. HEC Pharm Co., Ltd., 20-2545 (E.D. Pa.) | 29-May-20 | Hon. Wendy Beetlestone | Tradjenta® (linagliptin tablets) Jentadueto® (linagliptin / metformin tablets) | 9,415,016 10,022,379 10,034,877 |
| Eisai R&D Management Co., Ltd. v. Shilpa Medicare Ltd., 20-6729 (D.N.J.) | 1-Jun-20 | Hon. Freda L. Wolfson | Lenvima® (lenvatinib mesylate capsules) | 9,006,256 |
| Novo Nordisk Inc. v. Sandoz Inc., 20-0747 (D. Del.) | 3-Jun-20 | Hon. Colm F. Connolly | Victoza® (liraglutide recombinant solution injection) | 6,268,343 7,762,994 8,114,833 8,579,869 8,846,618 9,265,893 |
| Merck Sharp & Dohme Corp. v. Apotex Inc., 20-0749 (D. Del.) | 3-Jun-20 | Hon. Richard G. Andrews | Janumet XR® (metformin HCl / sitagliptin phosphate extended-release tablets) | 7,326,708 |
| Silvergate Pharms., Inc. v. Annora Pharma Private Ltd., 20-0753 (D. Del.) | 4-Jun-20 | Hon. Leonard P. Stark | Epaned® (enalapril powder for oral solution) | 9,669,008 9,808,442 10,039,745 10,154,987 |
| United Therapeutics Corp. v. Liquidia Technologies, Inc., 20-0755 (D. Del.) | 4-Jun-20 | Hon. Richard G. Andrews | Tyvaso® (treprostinil inhalation solution) | 9,593,066 9,604,901 |
| Novo Nordisk Inc. v. Sandoz Inc., 20-6842 (D.N.J.) | 4-Jun-20 | Hon. Renee Marie Bumb | Victoza® (liraglutide recombinant solution injection) | 6,268,343 7,762,994 8,114,833 8,579,869 8,846,618 9,265,893 |
| Sanofi-Aventis U.S. LLC v. Mylan Labs. Ltd., 20-0761 (D. Del.) | 5-Jun-20 | Hon. Richard G. Andrews | Jevtana® Kit (cabazitaxel injection) | 10,583,110 |
| Slayback Pharma LLC v. Sumitomo Dainippon Pharma Co., Ltd., IPR2020-01053 (PTAB) | 5-Jun-20 | N/A | Latuda® (lurasidone HCl tablets) | 9,815,827 |
| Genus Lifesciences Inc. v. Lannett Co., Inc., 20-0770 (D. Del.) | 8-Jun-20 | Hon. Leonard P. Stark | Goprelto® (cocaine HCl nasal solution) Numbrino® (cocaine HCl nasal solution) | 9,867,815 10,016,407 10,420,760 |
| Eton Pharms., Inc. v. Exela Pharma Sciences, LLC, PGR2020-000068 (PTAB) | 8-Jun-20 | N/A | Elcys® (cysteine HCl injection) | 10,583,155 |
| Merck Sharp & Dohme Corp. v. Lupin Ltd., 20-0776 (D. Del.) | 9-Jun-20 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) Janumet XR® (metformin HCl / sitagliptin phosphate extended-release tablets) | 7,326,708 |
| Bial – Portela & CA S.A. v. Hetero Labs Ltd., 20-0780 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
| Bial – Portela & CA S.A. v. Torrent Pharms. Ltd., 20-0781 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
| Bial – Portela & CA S.A. v. Lupin Ltd., 20-0782 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
| Bial – Portela & CA S.A. v. Jubilant Life Sciences Ltd., 20-0783 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
| Bial – Portela & CA S.A. v. Dr. Reddy’s Labs., Ltd., 20-0784 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
| Bial – Portela & CA S.A. v. Apotex Inc., 20-0785 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
| Bial – Portela & CA S.A. v. Alkem Labs. Ltd., 20-0786 (D. Del.) | 9-Jun-20 | Hon. Colm F. Connolly | Aptiom® (esclicarbazepine acetate tablets) | 10,675,287 |
| Astellas US LLC v. USV Private Ltd., 20-0793 (D. Del.) | 11-Jun-20 | Hon. Colm F. Connolly | Lexiscan® (regadenoson for injection) | 8,106,183 RE47,301 8,524,883 |
| Dr. Reddy’s Labs., Inc. v. Merck Sharp & Dohme Corp., IPR2020-01060 (PTAB) | 11-Jun-20 | N/A | Januvia® (sitagliptin phosphate tablets) Janumet® (metformin HCl / sitagliptin phosphate tablets) Janumet® XR (metformin HCl / sitagliptin phosphate extended-release tablets) Juvisync® (simvastatin / sitagliptin phosphate tablets) Steglujan® (ertugliflozin / sitagliptin phosphate tablets) | 7,326,708 |
| Sanofi-Aventis U.S. LLC v. Accord Healthcare Inc., 20-0803 (D. Del.) | 12-Jun-20 | Hon. Richard G. Andrews | Jevtana® Kit (cabazitaxel injection) | 10,583,110 |
| Sanofi-Aventis U.S. LLC v. Actavis LLC, 20-0804 (D. Del.) | 12-Jun-20 | Hon. Richard G. Andrews | Jevtana® Kit (cabazitaxel injection) | 10,583,110 |
| Sun Pharm. Indus. Ltd. Inc. v. Merck Sharp & Dohme Corp., IPR2020-01072 (PTAB) | 12-Jun-20 | N/A | Januvia® (sitagliptin phosphate tablets) Janumet® (metformin HCl / sitagliptin phosphate tablets) Janumet® XR (metformin HCl / sitagliptin phosphate extended-release tablets) Juvisync® (simvastatin / sitagliptin phosphate tablets) Steglujan® (ertugliflozin / sitagliptin phosphate tablets) |
7,326,708 |
| Takeda Pharms. U.S.A., Inc. v. Granules Pharms., Inc., 20-0812 (D. Del.) | 16-Jun-20 | Hon. Richard G. Andrews | Colcrys® (colchicine tablets) | 7,906,519 7,935,731 7,964,648 8,093,297 8,093,298 |
| Merck Sharp & Dohme Corp. v. Ajanta Pharma Ltd., 20-0815 (D. Del.) | 17-Jun-20 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
| Takeda Pharms. U.S.A., Inc. v. Dr. Reddy’s Labs., Ltd., 20-0845 (D. Del.) | 24-Jun-20 | Hon. Richard G. Andrews | Colcrys® (colchicine tablets) | 7,906,519 7,935,731 7,964,648 8,093,297 8,093,298 |
| Merck Sharp & Dohme Corp. v. Dr. Reddy’s Labs., Inc., 20-0847 (D. Del.) | 24-Jun-20 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) Janumet® (metformin HCl / sitagliptin phosphate tablets) | 7,326,708 |
| Merz Pharms., LLC v. Granules Pharms., Inc., 20-0848 (D. Del.) | 24-Jun-20 | Hon. Richard G. Andrews | Cuvposa® (glycopyrrolate oral solution) | 7,638,552 7,816,396 |
| Celgene Corp. v. Cipla Ltd., 20-7759 (D.N.J.) | 24-Jun-20 | 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 7,189,740 8,404,717 9,056,120 |
| Bristol-Myers Squibb Co. v. Lupin Ltd., 20-0854 (D. Del.) | 25-Jun-20 | Hon. Colm F. Connolly | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 |
| Bristol-Myers Squibb Co. v. Lupin Ltd., 20-7810 (D.N.J.) | 25-Jun-20 | Hon. Michael A. Shipp | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 |
| Supernus Pharms., Inc. v. Apotex Inc., 20-7870 (D.N.J.) | 26-Jun-20 | Hon. Freda L. Wolfson | Oxtellar XR® (oxcarbazepine extended-release tablets) |
7,722,898 7,910,131 8,617,600 8,821,930 9,119,791 9,351,975 9,370,525 9,855,278 10,220,042 |
| Astellas US LLC v. Hospira, Inc., 20-0893 (D. Del.) | 30-Jun-20 | Hon. Colm F. Connolly | Lexiscan® (regadenoson for injection) | 8,106,183 RE 47,301 8,524,883 |
GENERICally Speaking Summer 2020
Related Professionals
Christopher A. Pinahs
Partner
GENERICally Speaking Summer 2020
VOL. 10, NO. 2 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.