- 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
-
December 2, 2024Robins Kaplan LLP Announces 2025 Partners
-
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
-
December 11, 20242024 Year in Review: eDiscovery and Artificial Intelligence
-
December 12, 2024Strategies for Licensing AI: A Litigation Perspective
-
December 2024A Landmark Victory for Disabled Homeless Veterans: Q&A with the Trial Team
-
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
-
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 Litigation Settlements
Reported settlements in federal district court cases
Third Quarter
This ANDA Litigation Settlements chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act.
Case Name | Drug | Patent No(s). | Publicly Available Terms |
---|---|---|---|
Actelion Pharms. US, Inc. v. Alembic Pharms. Ltd., 23-0383 (D. Del.) | Uptravi® (selexipag tablets) | 7,205,302 | The patent-in-suit is valid and enforceable. Unless otherwise authorized by Plaintiffs, Alembic is enjoined from infringing the patents-in-suit through and until after the later of (a) October 31, 2026, or (b) the last day of any period of pediatric exclusivity that is or may become associated with the ’302 patent. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party. |
Fresenius Kabi USA, LLC v. Steriscience PTE Ltd., 22-1810 (D.N.J.) | Levothyroxine sodium powder for injection | 9,006,289 9,168,238 9,168,239 | All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. |
Astellas Pharma Inc. v. Humanwell Puracap Pharms. (Wuhan) Co., Ltd., 23-1020 (D.N.J.) | Xtandi® (enzalutamide capsules) | 7,709,517 8,183,274 | Each of plaintiffs’ claims against Defendants with respect to the patents-in-suit is dismissed with prejudice. The parties shall each bear their own costs. |
Novartis Pharms. Corp. v. Alembic Pharms. Ltd., 19-2021, 21-1330 (D. Del.) | Entresto® (sacubitril / valsartan tablets) | 8,101,659 8,796,331 8,877,938 9,388,134 11,096,918 | Consent Judgement and Order of Injunction between Plaintiff and Defendants Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. sealed. |
Servier Pharms. LLC v. Alembic Pharms. Ltd., 22-1420 (D. Del.) | Tibsovo® (ivosidenib tablets) | 9,968,595 10,449,184 10,799,490 10,980,788 | Case stayed. Order sealed. |
Anacor Pharms., Inc. v. Dr. Reddy’s Labs., Ltd., 21-1349 (D. Del.) | Eucrisa® (crisaborole ointment) | 8,039,451 8,168,614 8,501,712 9,682,092 | All claims and counterclaim are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. DRL will not infringe the patents-in-suit, except as provided for in the parties’ settlement and license agreement. |
Abraxis Bioscience, LLC v. Mylan Pharms. Inc., 23-0033 (N.D.W.V.) | Abraxane® (paclitaxel protein-bound particles for injectable suspension) | 7,820,788 | Until expiration of the ’788 patent, Mylan is enjoined from infringing the ’788 patent. All claims, counterclaims, affirmative defenses, and demands are hereby dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Mylan from maintaining a “Paragraph IV Certification” with respect to the ’788 patent. Nothing restricts FDA approving Mylan’s ANDA. |
Novartis Pharms. Corp. v. Ingenus Pharms., LLC, 22-1045 (D. Del.) | Xiidra® (lifitegrast ophthalmic solution) | 8,084,047 8,168,655 8,367,701 8,592,450 8,927,574 9,085,553 9,353,088 9,447,077 9,890,141 11,058,677 | All claims and defenses are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
Takeda Pharms. U.S.A., Inc. v. Sun Pharm. Indus. Ltd., 22-0911 (D. Del.) | Mydayis® (mixed salts of a single-entity amphetamine product extended-release capsules) | 8,846,100 9,173,857 | The patents-in-suit are valid and enforceable solely with respect to the Sun ANDA product. All affirmative defenses, claims, and counterclaims, which have been or could have been raised with respect to the validity or enforceability are dismissed with prejudice. Sun admits that in the absence of a license, its ANDA product infringes infringe each of the patents-in-suit. Except as authorized by Plaintiffs, Sun is enjoined during the term of the patents-in-suit from infringing the patents-in-suit or from challenging the validity or enforceability of the patents-in-suit. Any Protective Order entered by the Court shall remain in full force notwithstanding the conclusion of this action. The parties waive all right to appeal. Each party shall bear its own costs, expenses, and attorneys’ fees. Nothing shall prohibit (i) Sun from maintaining or filing Paragraph IV certifications and (ii) FDA from reviewing or approving Sun’s ANDA. |
Bayer Intellectual Property GmbH v. Biocon Pharma Ltd., 23-0334 (D. Del.) | Xarelto® (rivaroxaban tablets) | 9,539,218 10,828,310 | All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
Aragon Pharms., Inc. v. Sandoz Inc., 22-0678 (D. Del.) | Erleada® (apalutamide tablets) | 8,445,507 8,802,689 9,388,159 9,481,663 9,987,261 | Plaintiffs dismiss the action without prejudice. |
Merck Sharp & Dohme LLC v. Biocon Pharma Ltd., 23-0683 (D. Del.) | Januvia® (sitagliptin phosphate tablets) | 7,326,708 | Unless otherwise authorized pursuant to the settlement agreement, Biocon is enjoined from infringing the ’708 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
Newron Pharms. S.p.A. v. Aurobindo Pharma Ltd., 21-0843 (D. Del.) | Xadago® (safinamide tablets) | 8,076,515 8,278,485 8,283,380 | The parties have entered into a confidential settlement agreement resolving this action. All affirmative defenses, claims, and counterclaims, which have been or could have been raised by Plaintiffs against Prinston, or by Prinston against Plaintiffs, are dismissed without prejudice. The Parties waive all right to appeal. Each party is to bear its own costs and attorneys’ fees. |
Supernus Pharms., Inc. v. Riconpharma LLC, 21-12133 (D.N.J.) | 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 | All claims, counter-claims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. |
Anacor Pharms., Inc. v. Macleods Pharms. Ltd., 21-1350 (D. Del.) | Eucrisa® (crisaborole ointment) | 8,039,451 8,168,614 8,501,712 9,682,092 | All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. The parties have entered into a settlement and license agreement, and Macleods will not infringe the patents-in-suit with its ANDA product, except as provided by the settlement agreement. |
Gilead Sciences, Inc. v. Natco Pharma Ltd., 22-0852, 22-1259 (D. Del.) | Zydelig® (idelalisib tablets) | RE44,599 RE44,638 8,865,730 9,469,643 9,492,449 10,730,879 | All affirmative defenses, claims, and counterclaims are dismissed without prejudice. Except as provided by the parties’ agreement, Natco is enjoined from infringing the patents-in-suit. The parties waive all right to appeal. Each party shall bear its own costs and attorneys’ fees. |
Pfizer Inc. v. Sun Pharm. Indus. Ltd., 23-0718 (D. Del.) | Xeljanz® XR (tofacitinib citrate extended-release tablets) | RE41,783 | Plaintiffs dismiss all claims without prejudice. |
Pfizer Inc. v. Annora Pharma Private Ltd., 23-0634 (D. Del.) | Xeljanz® (tofacitinib oral solution) | RE41,783 | Plaintiffs dismiss all claims without prejudice. |
Apotex Inc. v. Boehringer Ingelheim Pharms., Inc., 23-0704 (D. Del.) | Tradjenta® (linagliptin tablets) | 8,673,927 8,846,695 8,883,805 | The Court grants final judgment that the claims of the ’927 patent are invalid for obviousness and obviousness-type double patenting. Final judgment of invalidity of the ’927 patent is therefore entered in favor of Apotex. The Court grants final judgment that the claims of the ‘695 patent are not enforceable since all claims have been disclaimed by the patentee. Final judgment of unenforceability of the ‘695 patent is therefore entered in favor of Apotex. The Court grants final judgment that Apotex’s ANDA and product do not infringe any claim of the ‘805 patent. Final judgment of non-infringement of the ‘805 patent is therefore entered in favor of Apotex. This final judgment shall not have any preclusive effect in any cause of action, litigation, or proceeding with respect to any other product other than the Apotex ANDA product. Each party shall bear its own fees and costs. |
Takeda Pharms. America, Inc. v. Teva Pharms., Inc., 22-7454 (D.N.J.) | Iclusig® (ponatinib HCl tablets) | 9,493,470 11,192,895 11,192,897 11,384,086 | Until expiration of the patents-in-suit, Teva is enjoined from infringing the patents-in-suit, except as specifically authorized by Takeda. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Teva from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving Teva’s ANDA. |
Boehringer Ingelheim Pharms. Inc. v. Ajanta Pharma Ltd., 23-847, 23-0848, 23-849 (D. Del.) | Jardiance® (empagliflozin tablets) | 9,949,998 10,258,637 11,090,323 | The patents-in-suit are valid and enforceable with respect to the Ajanta ANDA products. Making and selling Ajanta’s ANDA products would infringe the patents-in-suit. Unless authorized by BI, Ajanta is enjoined from infringing the patents-in-suit until their expiration. Neither this judgment nor the entry of this consent judgment may be asserted by BI against Ajanta, and there shall be no preclusive effect in any proceeding with respect to any product other than the Ajanta ANDA products with respect to the patents-in-suit. The parties shall bear their own fees and costs. The complaints and all remaining claims, counterclaims, or affirmative defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
Alkermes, Inc. v. Teva Pharm. Indus. Ltd., 20-12470 (D.N.J.) | Vivitrol® (extended-release naltrexone for injection) | 7,919,499 | Terms not public. |
Galderma Labs., L.P. v. Dr. Reddy’s Labs., Ltd., 23-0711 (D. Del.) | Oracea® (doxycycline capsules | 7,749,532 8,206,740 | All claims, counterclaims, and affnmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party. |
Boehringer Ingelheim Pharms. Inc. v. Cipla Ltd., 18-1789, 19-1494 (D. Del.) | Jardiance® (empagliflozin tablets) Synjardy XR® (empagliflozin / metformin HCl extended-release tablets) | 9,949,998 10,258,637 | The patents-in-suit are valid and enforceable. Unless specifically authorized, Cipla is enjoined from infringing the patents-in-suit until the expiration of the patents-in-suit. The parties shall bear their own costs and fees, including attorneys’ fees. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice. |
Bristol-Myers Squibb Co. v. Xspray Pharma AB, 22-0964 (D.N.J.) | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 | All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. |
Evofem Biosciences, Inc. v. Padagis Israel Pharms. Ltd., 23-3003 (D.N.J.) | Phexxi® (lactic acid / citric acid / potassium bitartrate vaginal gel) | 10,568,855 11,337,989 11,439,610 | Padagis has amended its PIV certifications to the patents-in-suit to PIII certifications. All claims, counterclaims, and defenses are voluntarily dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. |
Azurity Pharms., Inc. v. Alkem Labs Ltd., 23-0079 (D.N.J.) | Eprontia® (topiramate oral solution) | 11,433,046 | All claims and counterclaims are dismissed without prejudice. The parties shall bear their own fees and costs. |
Astellas Pharma Inc. v. Qilu Pharma, Inc., 23-0022 (D. Del.) | Myrbetriq® (mirabegron extended-release tablets) | 10,842,780 | All claims asserted against Qilu are dismissed without prejudice, and all defenses to such claims and counterclaims are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
Otsuka Pharm. Co., Ltd. v. Apotex Inc., 23-0710 (D. Del.) | Jynarque® (tolvaptan tablets) | 8,501,730 8,273,735 | With respect to Apotex’s ANDA and ANDA products, the patents-in-suit are valid and enforceable. Apotex stipulates that the patents-in-suit would be infringed by its ANDA products. Apotex, except as licensed by Plaintiff, will be enjoined until expiration of the patents-in-suit from infringing the patents-in-suit. Each party will bear its own attorneys’ fees and costs. |
Par Pharm., Inc. v. Cipla Ltd., 23-1150 (D.N.J.) | Vasostrict® (vasopressin injection) | 9,919,026 9,925,233 9,962,422 9,968,649 9,974,827 9,981,006 10,010,575 9,925,234 | All claims, counterclaims, causes of action, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. |
Actelion Pharms. Ltd. v. Apotex Inc., 23-0734 (D. Del.) | Opsumit® (macitentan tablets) | 7,094,781 | Apotex admits the ’781 patent is valid and enforceable and that its claims would be infringed by the ANDA product. Unless otherwise authorized by plaintiff, Apotex is enjoined from infringing the ’781 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
Actelion Pharms. US, Inc. v. Alembic Pharms. Ltd., 23-1902 (D.N.J.) | Opsumit® (macitentan tablets) | 7,094,781 | Alembic admits the ’781 patent is valid and enforceable and that its claims would be infringed by the ANDA product. Unless otherwise authorized by plaintiff, Alembic is enjoined from infringing the ’781 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
GENERICally Speaking Hatch Waxman Bulletin
GENERICally Speaking Hatch Waxman Bulletin
READ MORE 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.