- 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 18, 2024Robins Kaplan Named Minnesota Firm of The Year by Benchmark Litigation
-
March 12, 2024Anthony Froio Elected Chair of Executive Board and Managing Partner of Robins Kaplan
-
March 12, 2024Robins Kaplan Recognized in 2024 World Trademark Review 1000
-
March 19, 2024USC Gould School of Law 2024 Intellectual Property Institute
-
March 17-20, 2024PLRB 2024 Claims Conference
-
March 26, 2024Generative AI Generates Debate
-
March 2024Do We Have to Share That Information? Attorney-Client Privilege in the Multi-Entity Context
-
March 2024Sellers of a Business: Know Thyself.
-
March 2024Unintended Consequences: Don’t Forget the Litigation Risks When Getting a Deal Done
-
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
Second Quarter
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). |
---|---|---|---|---|
United Therapeutics Corp. v. ANI Pharms., Inc., 21-0489 (D. Del.) | Apr. 1, 2021 | Hon. Richard G. Andrews | Orenitram® (treprostinil extended-release tablets) | 7,417,070 7,544,713 8,252,839 8,349,892 8,410,169 8,747,897 9,050,311 9,278,901 9,393,203 9,422,223 9,593,066 9,604,901 |
EPI Health, LLC v. Perrigo UK Finco Ltd. Partnership, 21-0498 (D. Del.) | Apr. 5, 2021 | Hon. Colm F. Connolly | Rhofade® (oxymetazoline HCl cream) | 7,812,049 8,420,688 8,815,929 8,883,838 9,974,773 10,335,391 10,751,325 |
Azurity Pharms., Inc. v. Amneal Pharms. LLC, 21-8717 (D.N.J.) | Apr. 8, 2021 | Hon. Freda L. Wolfson | Katerzia® (amlodipine oral suspension) | 10,695,329 10,799,453 10,894,039 10,952,998 |
Purdue Pharma L.P. v. Collegium Pharm., Inc., 21-10598 (D. Mass.) | Apr. 9, 2021 | Hon. F. Dennis Saylor, IV | OxyContin® (oxycodone HCl extended-release tablets) Xtampza® ER (oxycodone extended-release capsules) | 10,407,434 |
Boehringer Ingelheim Pharms. Inc. v. Lupin Ltd., 21-0530 (D. Del.) | Apr. 13, 2021 | Hon. Colm F. Connolly | Trijardy® XR (empagliflozin / linagliptin / metformin HCl extended-release tablets) | 8,551,957 9,155,705 9,415,016 9,949,998 10,022,379 10,258,637 10,406,172 |
Duchesnay Inc. v. Hetero Labs Ltd., 21-0538 (D. Del.) | Apr. 14, 2021 | Hon. Leonard P. Stark | Osphena® (ospemifene tablets) | 8,642,079 |
CMP Development, LLC v. Amneal Pharms. LLC, 21-0549 (D. Del.) | Apr. 16, 2021 | Hon. Maryellen Noreika | CaroSpir® (spironolactone oral suspension) | 9,757,394 10,493,083 10,624,906 10,660,907 10,888,570 |
AstraZeneca AB v. Zydus Pharms. (USA), Inc., 21-0550 (D. Del.) | Apr. 16, 2021 | Hon. Richard G. Andrews | Tagrisso® (osimertinib mesylate tablets) | 10,183,020 |
Bayer Pharma AG v. Accord Healthcare Inc., 21-0566 (D. Del.) | Apr. 22, 2021 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
Bausch Health Ireland Ltd. v. MSN Labs. Private Ltd., 21-10057 (D.N.J.) | Apr. 22, 2021 | Hon. Stanley R. Chesler | Trulance® (plecanatide tablets) | 7,041,786 7,799,897 8,637,451 9,610,321 9,616,097 9,919,024 9,925,231 10,011,637 |
Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 21-0580 (D. Del.) | Apr. 26, 2021 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | RE48,059 |
Celgene Corp. v. Hikma Pharms. USA, Inc., 21-10398 (D.N.J.) | Apr. 28, 2021 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,189,740 7,465,800 7,855,217 7,968,569 8,404,717 8,530,498 8,648,095 9,056,120 9,101,621 9,101,622 |
Bausch Health Ireland Ltd. v. Mylan Labs. Ltd., 21-10403 (D.N.J.) | Apr. 28, 2021 | Hon. Stanley R. Chesler | Trulance® (plecanatide tablets) | 7,041,786 7,799,897 8,637,451 9,610,321 9,616,097 9,919,024 9,925,231 10,011,637 |
Bausch Health Ireland Ltd. v. Mylan Labs. Ltd., 21-0611 (D. Del.) | Apr. 29, 2021 | Hon. Leonard P. Stark | Trulance® (plecanatide tablets) | 7,041,786 7,799,897 8,637,451 9,610,321 9,616,097 9,919,024 9,925,231 10,011,637 |
Mayne Pharma LLC v. Perrigo Israel Pharms. Ltd., 21-0612 (D. Del.) | Apr. 29, 2021 | Hon. Colm F. Connolly | Lexette® (halobetasol propionate topical foam) | 10,857,159 |
Bausch Health Ireland Ltd. v. Mylan Labs. Ltd., 21-0573 (W.D. Pa.) | Apr. 30, 2021 | Hon. W. Scott Hardy | Trulance® (plecanatide tablets) | 7,041,786 7,799,897 8,637,451 9,610,321 9,616,097 9,919,024 9,925,231 10,011,637 |
Novartis Pharms. Corp. v. Handa Neuroscience, LLC, 21-0645 (D. Del.) | 4-May-21 | Hon. Leonard P. Stark | Gilenya® (fingolimod tablets) | 9,187,405 10,543,179 |
Novartis Pharms. Corp. v. Handa Neuroscience, LLC, 21-3397 (N.D. Ca.) | 6-May-21 | Hon. Edward J. Davila | Gilenya® (fingolimod tablets) | 9,187,405 10,543,179 |
Amgen Inc. v. Aurobindo Pharma Ltd., 21-0662 (D. Del.) | 6-May-21 | Hon. Maryellen Noreika | Parsabiv® (etelcalcetide for injection) | 9,820,938 10,344,765 |
Astellas Pharma Inc. v. Sandoz Inc., 21-0664 (D. Del.) | 7-May-21 | Hon. Joseph F. Bataillon | Myrbetriq® (mirabegron extended-release tablets) | 10,842,780 |
Astellas US LLC v. American Regent, Inc., 21-0671 (D. Del.) | 7-May-21 | Hon. Colm F. Connolly | Lexiscan® (regadenoson for injection) | 8,106,183 RE47,301 8,524,883 |
Jazz Pharms., Inc. v. Avadel Pharms. PLC, 21-0691 (D. Del.) | 12-May-21 | Hon. Maryellen Noreika | Xyrem® (sodium oxybate oral solution) | 8,731,963 10,758,488 10,813,885 10,959,956 10,966,931 |
Teva Pharms. Int’l GmbH v. Dr. Reddy’s Labs., Ltd., 21-0695 (D. Del.) | 13-May-21 | Hon. Colm F. Connolly | Bendeka® (bendamustine HCl for 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 |
Melinta Therapeutics, LLC v. Nexus Pharms., Inc., 21-11198 (D.N.J.) | 13-May-21 | Hon. Brian R. Martinotti | Minocin® (minocycline for injection) | 9,278,105 9,084,802 |
Melinta Therapeutics, LLC v. Nexus Pharms., Inc., 21-2636 (N.D. Ill.) | 14-May-21 | Hon. John F. Kness | Minocin® (minocycline for injection) | 9,278,105 9,084,802 |
Bausch Health Ireland Ltd. v. Lupin Ltd., 21-11258 (D.N.J.) | 14-May-21 | Hon. Renee Marie Bumb | Plenvu® (PEG 3350 / sodium ascorbate / sodium sulfate / ascorbic acid / sodium chloride / potassium chloride oral solution) | 10,918,723 |
Celgene Corp. v. Biocon Pharma Ltd., 21-11261 (D.N.J.) | 14-May-21 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,189,740 7,465,800 7,855,217 7,968,569 8,404,717 8,530,498 8,648,095 9,056,120 9,101,621 9,101,622 |
Amgen Inc. v. MSN Labs. Private Ltd., 21-0712 (D. Del.) | 19-May-21 | Hon. Maryellen Noreika | Parsabiv® (etelcalcetide for injection) | 8,377,880 8,999,932 9,278,995 9,701,712 9,820,938 10,344,765 |
Bayer Pharma AG v. Dr. Reddy’s Labs., Inc., 21-0732 (D. Del.) | 24-May-21 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
Almirall, LLC v. Acrux DDS Pty. Ltd., 21-11948 (D.N.J.) | 28-May-21 | Hon. Madeline Cox Arleo | Aczone® (dapsone gel) | 9,517,219 |
Supernus Pharms., Inc. v. Riconpharma LLC, 21-12133 (D.N.J.) | 3-Jun-21 | 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 |
Merck Sharp & Dohme Corp. v. Alkem Labs. Ltd., 21-0824 (D. Del.) | 4-Jun-21 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
Taiho Pharm. Co., Ltd. v. Accord Healthcare Inc., 21-0838 (D. Del.) | 9-Jun-21 | Hon. Colm F. Connolly | Lonsurf® (tipiracil HCl / trifluridine tablets) | 10,960,004 |
Newron Pharms. S.p.A. v. Aurobindo Pharma Ltd., 21-0843 (D. Del.) | 10-Jun-21 | Hon. Richard G. Andrews | Xadago® (safinamide tablets) | 8,076,515 8,278,485 8,283,380 |
Pfizer Inc. v. MSN Pharms. Inc., 21-0858 (D. Del.) | 15-Jun-21 | Hon. Colm F. Connolly | Ibrance® (palbociclib tablets) | 10,723,730 |
Exelixis, Inc. v. Teva Pharm. Indus. Ltd., 21-0871 (D. Del.) | 17-Jun-21 | Hon. Richard G. Andrews | Cabometyx® (cabozantinib s-malate tablets) | 9,724,342 10,039,757 10,034,873 |
Novartis Pharms. Corp. v. Fresenius Kabi USA, LLC, 21-0870 (D. Del.) | 17-Jun-21 | Hon. Leonard P. Stark | Kisqali® (ribociclib tablets) Kisqali® Femara® Co-pack (ribociclib / letrozole tablets) | 8,324,225 8,415,355 8,685,980 8,962,630 9,193,732 9,416,136 9,868,739 10,799,506 |
Apotex Inc. v. Pfizer Inc., IPR2021-01132 (PTAB) | 17-Jun-21 | N/A | Chantix® (varenicline tartrate tablets) | 6,890,927 |
AstraZeneca AB v. Alembic Pharms. Ltd., 21-0875 (D. Del.) | 18-Jun-21 | Hon. Richard G. Andrews | Brilinta® (ticagrelor tablets) | 8,425,934 10,300,065 |
TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 21-12794 (D.N.J.) | 21-Jun-21 | Hon. Brian R. Martinotti | Imvexxy® (estradiol vaginal inserts) | 10,888,516 |
Tris Pharma, Inc. v. Ascent Pharms., Inc., 21-12867 (D.N.J.) | 22-Jun-21 | Hon. Kevin McNulty | QuilliChew ER® (methylphenidate HCl extended-release chewable tablets) | 8,999,386 9,295,642 9,545,399 9,844,544 |
Azurity Pharms., Inc. v. Bionpharma Inc., 21-12870 (D.N.J.) | 22-Jun-21 | Hon. Michael A. Shipp | Epaned® (enalapril maleate oral solution) | 11,040,023 |
Otsuka Pharm. Co., Ltd. v. Lupin Ltd., 21-0900 (D. Del.) | 23-Jun-21 | Hon. Richard G. Andrews | Jynarque® (tolvaptan tablets) | 8,501,730 10,905,694 |
Celgene Corp. v. Torrent Pharms. Ltd., 21-12927 (D.N.J.) | 23-Jun-21 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,189,740 7,465,800 7,855,217 7,968,569 8,404,717 8,530,498 8,648,095 9,056,120 9,101,621 9,101,622 |
Takeda Pharms. America, Inc. v. Apotex, Inc., 21-12998 (D.N.J.) | 25-Jun-21 | Hon. Kevin McNulty | Iclusig® (ponatinib HCl tablets) | 9,493,470 |
Pfizer Inc. v. Qilu Pharm. Co., Ltd., 21-0929 (D. Del.) | 29-Jun-21 | Hon. Colm F. Connolly | Ibrance® (palbociclib capsules) | 10,723,730 |
Teva Pharms. Int’l GmbH v. Accord Healthcare Inc., 21-0952 (D. Del.) | 29-Jun-21 | 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 |
Amphastar Pharms. Inc. v. Eli Lilly and Co., 21-1922 (S.D. Ind.) | 29-Jun-21 | Hon. Richard L. Young | Forteo® (teriparatide injection) | 7,517,334 |
Novartis Pharms. Corp. v. Micro Labs Ltd., 21-0969 (D. Del.) | 30-Jun-21 | Hon. Leonard P. Stark | Xiidra® (lifitegrast ophthalmic solution) | 7,314,938 7,745,460 7,790,743 7,928,122 9,216,174 10,124,000 8,084,047 8,592,450 8,168,655 8,367,701 9,447,077 8,927,574 9,353,088 9,890,141 9,085,553 |
Astellas Pharma Inc. v. Sandoz Inc., 21-13177 (D.N.J.) | 30-Jun-21 | Hon. John Michael Vazquez | Xtandi® (enzalutamide tablets) | 7,709,517 8,183,274 |
GENERICally Speaking Spring 2021
GENERICally Speaking Spring 2021
Summer 2021 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.