Reported settlements in federal district court cases
This 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 |
| Pfizer Inc. v. Somerset Therapeutics LLC, 25-0617 (D. Del.) | Xeljanz® (tofacitinib tablets) | RE41,783 | All claims dismissed without prejudice. |
| Gilead Sciences, Inc. v. Cipla Ltd., 23-1480 (D. Del.) | Biktarvy® (bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate tablets) | 9,708,342 10,385,067 |
All affirmative defenses, claims, and counterclaims are dismissed without prejudice. The claims of the patents-in-suit are valid and enforceable with respect to the Cipla ANDA product. Except as agreed by the parties, Cipla is enjoined from infringing the patents-in-suit until the date agreed by the parties. The parties waive all right to appeal. Each party is to bear its own costs and attorneys’ fees. Nothing shall prevent FDA from granting final approval to Cipla’s ANDA. Nothing in this dismissal order applies to any product other than the Cipla ANDA product. |
| Pfizer Inc. v. Prinston Pharm. Inc., 25-1202 (D. Del.) | Xeljanz® (tofacitinib tablets) | RE41,783 | All claims dismissed without prejudice. |
| Onyx Therapeutics, Inc. v. Somerset Therapeutics, LLC, 25-0500 (D. Del.) | Kyprolis® (carfilzomib injection) | 7,737,112 | Somerset admits that the asserted claims are valid and enforceable. Somerset admits that its ANDA product would infringe the patents-in-suit. Until the expiration or delisting from the Orange Book, of the patents-in-suit, Somerset is enjoined from infringing the patents-in-suit, except as authorized by Onyx in writing. Onyx dismisses with prejudice all claims and demands, and without costs, disbursements, or attorneys’ fees to any party. |
| Novartis Pharms. Corp. v. Cipla Ltd., 25-0186 (D. Del.) | Mayzent® (siponimod tablets) | 8,492,441 11,944,602 12,071,402 |
All claims are dismissed without prejudice. Each party will bear its respective attorneys’ fees and costs. |
| Esperion Therapeutics, Inc. v. Dr. Reddy’s Labs. Inc., 24-6391 (D.N.J.) | Nexletol® (bempedoic acid tablets) Nexlizet® (bempedoic acid / ezetimibe tablets) | 7,335,799 11,760,714 11,613,511 10,912,751 11,744,816 |
All claims and counterclaims are dismissed without prejudice, with each party to bear its own costs, fees, and expenses. |
| American Regent, Inc. v. Hikma Pharms. USA Inc., 25-2224, 25-14671 (D.N.J.) | Tralement® (trace elements zinc sulfate / cupric sulfate / manganese sulfate / selenious acid injection) Multrys® (trace elements zinc / copper / manganese / selenium injection) | 11,786,548 11,975,022 11,998,565 12,150,956 12,150,957 |
Unless authorized by ARI pursuant to the settlement agreement, Hikma is enjoined from infrining the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed witout prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall preclude FDA from granting final approval to the Hikma ANDA or shall preclude Hikma from filing, modifying, or maintaining any Paragraph IV Certification for the Hikma ANDA products. |
| Eli Lilly & Co. v. Humanwell Pharm. US, Inc., 25-2020 (D.N.J.) | Reyvow® (lasmiditan tablets) | 11,053,214 | All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to any party. |
| Actelion Pharms. Ltd. v. Gland Pharma Ltd., 24-0434 (D. Del.) | Veletri® (epoprostenol sodium for injection) | 8,598,227 | The filing of the Gland ANDA was an act of infringement under § 271(e)(2)(A). The asserted claims are valid and enforceable with respect to the Gland ANDA product. Except as authorized in writing by Actelion, Gland is enjoined from infringing the ’227 patent until its expiration. Nothing shall prohibit Gland from maintaining and/or filing a Paragraph IV Certification with respect to the Gland ANDA and the ’227 patent. Nothing shall restrict FDA from granting final approval of the Gland ANDA. Nothing shall restrict Gland from making and selling the Gland ANDA product before the expiration of the‘’227 patent as authorized by Actelion. All claims, affirmative defenses, and counterclaims are dismissed without prejudice. Each party shall bear its own fees and costs, including attorneys’ fees. The parties agree not to appeal this order. |
| Allergan, Inc. v. Amneal Pharms. of New York, LLC, 23-6208 (E.D.N.Y.) | Lumigan® (bimatoprost ophthalmic solution) | 7,851,504 | The filing of Amneal’s ANDA was an act of infringement of the ’504 patent under 35 U.S.C. § 271(e)(2)(A). All other claims, counterclaims, and defenses are dismissed without prejudice. Amneal is enjoined from infringing the ‘’504 patent during the life of the ‘’504 patent, absent a license agreement or other authorization by Plaintiffs. The parties waive any right to appeal. The stipulation and order is without prejudice to any claim, defense, or counterclaim in any possible future action between Amneal and Plaintiffs regarding the ‘’504 patent and a product other than the Amneal ANDA product. |
| Astellas Pharma Inc. v. MSN Pharms. Inc., 23-0689 (D. Del.) | Myrbetriq® (mirabegron extended-release tablets) | 10,842,780 11,707,451 12,059,409 12,097,189 |
Pursuant to a settlement and license agreement, the parties request that the court dismiss all claims without prejudice. The parties will submit their settlement and license agreement to the FTC and DOJ as soon as practicable. Each party will bear its own costs and attorneys’ fees. |
| Astellas Pharma Inc. v. Cipla Ltd., 24-1287 (D. Del.) | Cresemba® (isavuconazonium sulfate injection) | 6,812,238 | Plaintiffs’ claims and Aspiro/Hetero’s counterclaims are dismissed with prejudice. Parties shall each bear their own costs. |
| Otsuka Pharm. Co., Ltd. v. Sun Pharm. Indus. Ltd., 24-0789 (D. Del.) | Abilify Maintena® (aripiprazole extended-release injectable suspension) | 10,525,057 10,980,803 11,154,553 11,344,547 11,400,087 11,648,347 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party. |
| Salix Pharms, Inc. v. Cipla USA, Inc., 24-10213 (D.N.J.) | Xifaxan® (rifaximin tablets) | 11,564,912 11,779,571 8,193,196 |
The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees. Plaintiffs acknowledge that Cipla is entitled to maintain its Paragraph IV certifications to U.S. Patent Nos. 8,193,196, 8,309,569, 10,456,384, 10,765,667, 11,564,912. Each party acknowledges and agrees that the 30-month stay with respect to the approval of the Cipla ANDA is terminated. |
| Actelion Pharms. Ltd. v. Seasons Biotechnology (Taizhou) Co. Ltd., 25-15027 (D.N.J.) | Opsumit® (macitentan tablets) | 7,094,781 10,946,015 |
Defendants admit that the patents-in-suit are valid and enforceable and that the claims would be infringed by Defendants’ ANDA product. Unless specifically authorized by Actelion, Defendants are enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Avadel CNS Pharms., LLC v. Jazz Pharms., Inc., 21-0691, 21-1138, 21-1594, 22-0487, 22-0941, 25-0009, 25-0057, 25-0221, 25-0435 (D. Del.) | Lumryz® (sodium oxybate extended-release oral suspension) | 12,167,991 12,186,298 |
Pursuant to the parties’ settlement agreement, all claims and counterclaims are dismissed with prejudice, with each party responsible for its own attorneys’ fees and costs. |
| Boehringer Ingelheim Pharms. Inc. v. Biocon Ltd., 25-0523 (D. Del.) | Tradjenta® (linagliptin tablets) | 8,853,156 9,486,526 10,034,877 11,911,388 |
Unless authorized, Biocon is enjoined from infringing the patents-in-suit until their expiration. If BI becomes entitled to any other regulatory exclusivities, BI may apply to the Court for modification of the consent judgment. Nothing prohibits Biocon from maintaining and/or filing a Paragraph IV Certification with respect to the patents-in-suit. All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party. |
| Incyte Corp. v. Hikma Pharms. USA Inc., 25-1859 (D.N.J.) | Jakafi® (ruxolitinib tablets) | 7,598,257 8,415,362 8,722,693 8,822,481 8,829,013 |
Until expiration of the patents-in-suit, Hikma is enjoined from infringing the patents-in-suit, unless specifically authorized by Incyte. All claims, counterclaims, affirmative defenses, motions, and petitions are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Hikma from maintaining any Paragraph IV Certification with respect to the patents-in-suit. Nothing prohibits Hikma from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving Hikma’s ANDA. including the previous 30-month stay of approval of Hikma’s ANDA. |
| American Regent, Inc. v. RK Pharma, Inc., 24-7791, 24-7805 (D.N.J.) | Selenious Acid | 11,998,565 12,150,957 |
Unless authorized by ARI pursuant to the settlement agreement or by 35 U.S.C. § 271(e)(1), RK Pharma is enjoined from infringing the licensed ARI patents. The terms of this consent judgment supersede those of the Preliminary Injunction Order entered by the Court on May 27, 2025, and said Order is hereby vacated as to RK Pharma. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall preclude FDA from granting final approval to RK Pharma’s ANDA or shall preclude RK Pharma from filing, modifying, or maintaining with the FDA any Paragraph IV Certification for the RK Pharma Product(s). |
| Heron Therapeutics, Inc. v. Qilu Pharm. Co., Ltd., 25-0829 (D. Del.) | Cinvanti® (aprepitant injectable emulsion) | 9,561,229 9,808,465 9,974,742 9,974,793 9,974,794 10,500,208 10,624,850 10,953,018 11,173,118 11,744,800 12,115,254 12,115,255 12,290,520 |
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Celgene Corp. v. USV Private Ltd., 25-6320 (D.N.J) | Pomalyst® (pomalidomide capsules) | 8,828,427 9,993,467 10,555,939 |
Until expiration of the patents-in-suit, USV is enjoined from infringing by itself or others the patents-in-suit, unless authorized by Celgene. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits USV from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing prohibits USV from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving USV’s ANDA. |
| Astellas Pharma Inc. v. Zydus Pharms. (USA) Inc., 24-9748 (D.N.J.) | Xtandi® (enzalutamide tablets) | 11,839,689 | All claims and counterclaims are dismissed with prejudice. The parties shall bear their own costs. |
| Bristol-Myers Squibb Co. v. Apotex, Inc., 24-0818 (D. Del.) | Zeposia® (ozanimod capsules) | 11,680,050 | All claims and counterclaims, defenses, motions, and petitions are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. The parties each expressly waive any right to appeal or otherwise move for relief. |
| Azurity Pharms., Inc. v. MSN Pharms. Inc., 25-13775 (D.N.J.) | Fleqsuvy® (baclofen oral suspension) | 11,324,696 11,446,246 |
Case is voluntarily dismissed, without prejudice. |
| UCB, Inc. v. Aurobindo Pharma Ltd., 24-11428 (D.N.J.) | Neupro® (rotigotine transdermal system) | 8,246,979 9,925,150 10,130,589 10,350,174 |
Unless otherwise authorized by UCB, Aurobindo is enjoined from infringing the patents-in-suit. All claims and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Eisai R&D Management Co., Ltd. v. Torrent Pharms. Ltd., 24-7067 (D.N.J.) | Lenvima® (lenvatinib mesylate capsules) | 7,612,208 10,407,393 11,186,547 |
Torrent agrees that the patents-in-suit are valid and enforceable with respect to the ANDA product and one or more claims would be infringed by the ANDA product. Except as authorized per the settlement agreement, Torrent is enjoined from infringing the patents-in-suit until their expiration. Nothing prohibits Torrent from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Novartis Pharms. Corp. v. Taro Pharms. USA, Inc., 25-13193 (D.N.J.) | Promacta® (eltrombopag olamine tablets) | 8,052,993 8,052,994 8,062,665 8,071,129 8,828,430 |
Novartis dismisses all claims without prejudice. Each party to bear its attorneys’ fees and costs. |
| Celgene Corp. v. Sandoz Inc., 25-16878 (D.N.J.) | Pomalyst® (pomalidomide capsules) | 8,828,427 9,993,467 10,555,939 |
Sandoz is enjoined from infringing the patents-in-suit until their expiration, unless otherwise authorized by Celgene. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Sandoz from maintaining any Paragraph IV Certification with respect to the patents-in-suit. Nothing prohibits Sandoz from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving Sandoz’s ANDA. |
| Astellas Pharma Inc. v. Hetero USA, Inc., 25-15434 (D.N.J.) | Xtandi® (enzalutamide tablets) | 11,839,689 12,161,628 |
Claims and counterclaims are dismissed with prejudice. Parties shall bear their own costs. |
| PH Health Ltd. v. Fresenius Kabi USA, LLC, 25-1096 (D. Del.) | Ephedrine Sulfate Injection | 10,869,845 | Plaintiff voluntarily dismisses case without prejudice. |
| Eisai R&D Management Co., Ltd. v. Torrent Pharms. Ltd., 24-7067 (D.N.J.) | Lenvima® (lenvatinib mesylate capsules) | 7,612,208 10,407,393 11,186,547 |
Torrent agrees that the patents-in-suit are valid and enforceable with respect to the ANDA product and one or more claims would be infringed by the ANDA product. Except as authorized per the settlement agreement, Torrent is enjoined from infringing the patents-in-suit until their expiration. Nothing prohibits Torrent from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Novartis Pharms. Corp. v. Taro Pharms. USA, Inc., 25-13193 (D.N.J.) | Promacta® (eltrombopag olamine tablets) | 8,052,993 8,052,994 8,062,665 8,071,129 8,828,430 |
Novartis dismisses all claims without prejudice. Each party to bear its attorneys’ fees and costs. |
| Celgene Corp. v. Sandoz Inc., 25-16878 (D.N.J.) | Pomalyst® (pomalidomide capsules) | 8,828,427 9,993,467 10,555,939 |
Sandoz is enjoined from infringing the patents-in-suit until their expiration, unless otherwise authorized by Celgene. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Sandoz from maintaining any Paragraph IV Certification with respect to the patents-in-suit. Nothing prohibits Sandoz from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving Sandoz’s ANDA. |
| Astellas Pharma Inc. v. Hetero USA, Inc., 25-15434 (D.N.J.) | Xtandi® (enzalutamide tablets) | 11,839,689 12,161,628 |
Claims and counterclaims are dismissed with prejudice. Parties shall bear their own costs. |
| PH Health Ltd. v. Fresenius Kabi USA, LLC, 25-1096 (D. Del.) | Ephedrine Sulfate Injection | 10,869,845 | Plaintiff voluntarily dismisses case without prejudice. |
| Novartis Pharms. Corp. v. Teva Pharms., Inc., 25-0928 (D. Del.) | Mekinist® (trametinib dimethyl sulfoxide tablets) | 8,580,304 9,155,706 9,271,941 9,399,021 |
Novartis dismisses all claims without prejudice. |
| Ferring Pharms. Inc. v. Alkem Labs. Ltd., 25-0810 (D. Del.) | Clenpiq® (sodium picosulfate / magnesium oxide / anhydrous citric acid oral solution) | 9,827,231 10,624,879 11,191,753 |
Alkem agrees that the asserted claims are valid and enforceable with respect to the Alkem ANDA product. Alkem agrees that absent a valid license, the patents-in-suit would be infringed by the Alkem ANDA product. Alkem shall not dispute that the patents-in-suit are enforceable and valid with respect to the Alkem ANDA product. Alkem is enjoined from infringing the patents-in-suit until their expiration, except as authorized by the settlement agreement. The parties consent decree and stipulation of dismissal does not constitute a judgment on the merits of any claim or counterclaim, and has no preclusive effect in any case other than in relation to Alkem’s ANDA product. All affirmative defenses, claims, and counterclaims are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Novartis Pharms. Corp. v. Lupin Ltd., 25-0578 (D. Del.) | Mayzent® (siponimod tablets) | 8,492,441 11,944,602 |
Novartis dismisses all claims without prejudice. Each party to bear its respective attorneys’ fees and costs. |
| American Regent, Inc. v. Cipla USA, Inc., 24-7796, 24-11112 (D.N.J.) | Selenious Acid | 11,998,565 12,150,957 |
Unless authorized by ARI, Cipla is enjoined from infringing the patents-in-suit. This consent judgment supersedes the preliminary injunction order entered May 27, 2025, which is not vacated. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall preclude FDA from graning final approval to Cipla’s ANDA or shall preclude Cipla from filing any Paragraph IV Certification for Cipla’s ANDA products. |
| AbbVie Inc. v. MSN Pharms. Inc., 24-4662 (D.N.J.) | Ubrelvy® (ubrogepant tablets) | 10,117,836 11,717,515 11,857,542 11,925,709 12,070,450 12,168,004 12,194,030 12,220,408 12,310,953 12,329,750 12,458,632 12,458,633 |
The filing of MSN’s ANDA was an a ct of infringement of the patents-in-suit. All other claims, counterclaims, and defneses are dismissed without prejudice. MSN is enjoined from infrining the patents-in-suit until their expiration, absent a license agreement or other authorization from AbbVie. The parties waive any right to appeal. Stipulation and order are without prejudice to any claim, defense, or counterclaim in any future action between the parties regarding the patents-in-suit and a product other than the MSN ANDA product. |
| Actelion Pharms. US, Inc. v. VGYAAN Pharms. LLC, 25-15227 (D.N.J.) | Uptravi® (selexipag tablets) | 7,205,302 | The ’302 patent is valid and enforceable. Unless authorized by Actelion, Defendants are enjoined from infringing the ’302 patent until its expiration. Parties waive all right to appeal. All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party. |
| Boehringer Ingelheim Pharms. Inc. v. Mylan Pharms. Inc., 20-0019, 20-0090, 24-0082 (N.D.W.V.) | Tradjenta® (linagliptin tablets) Jentadueto® (linagliptin / metformin tablets) | 9,415,016 9,486,526 10,022,379 11,033,552 11,911,388 |
In the absence of a license, the ’526, ’552, and ’388 patents are infringed by Mylan’s linagliptin product. In the absence of a license, the ’016, ’379, and ’388 patents are infringed by Mylan’s linagliptin / metformin product. Except as authorized by BI, Mylan is enjoined from infringing the patents-in-suit until their expiration. Mylan is entitled to maintain its Paragraph IV certification to the patents-in-suit. Nothing shall prevent FDA from granting or maintaining final approval to Mylan’s ANDAs. All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party. |
| American Regent, Inc. v. Aspiro Pharma Ltd., 24-7794, 24-11109 (D.N.J.) | Selenious Acid | 11,998,565 12,150,957 |
Unless authorized by ARI pursuant to the parties’ settlement agreement, Aspiro is enjoined from infinging the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall preclude FDA from granting final approval to Aspiro’s ANDA or shall preclude Aspiro from filing, modifying, or maintaining with the FDA any PIV Certification for the Aspiro ANDA product. |
| Bayer Pharma AG v. Apotex Inc., 25-0694 (D. Del.) | Xarelto® (rivaroxaban tablets) | 10,828,310 | Bayer and Janssen voluntarily dismiss all claims without prejudice. |
| Bayer Pharma AG v. Alembic Pharms. Ltd., 25-0753 (D. Del.) | Xarelto® (rivaroxaban tablets) | 10,828,310 | Bayer and Janssen voluntarily dismiss all claims without prejudice. |
| Bayer Pharma AG v. Lupin Ltd., 25-0349 (D. Del.) | Xarelto® (rivaroxaban tablets) | 10,828,310 | Bayer and Janssen voluntarily dismiss all claims without prejudice. |
| Bayer Pharma AG v. Dr. Reddy’s Labs., Inc., 25-1053 (D. Del.) | Xarelto® (rivaroxaban tablets) | 10,828,310 | Bayer and Janssen voluntarily dismiss all claims without prejudice. |
| Bayer Pharma AG v. Aurobindo Pharma Ltd., 25-0631 (D. Del.) | Xarelto® (rivaroxaban tablets) | 10,828,310 | Bayer and Janssen voluntarily dismiss all claims without prejudice. |
| Bayer Pharma AG v. Cipla Ltd., 25-1196 (D. Del.) | Xarelto® (rivaroxaban tablets) | 10,828,310 | Bayer and Janssen voluntarily dismiss all claims without prejudice. |
| Bayer Pharma AG v. Macleods Pharms. Ltd., 25-0719 (D. Del.) | Xarelto® (rivaroxaban tablets) | 10,828,310 | The parties dismiss all claims, counterclaims, and defenses with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Bayer Pharma AG v. Taro Pharm. Indus. Ltd., 21-1000, 23-1219 (D. Del.) | Xarelto® (rivaroxaban tablets) | 10,828,310 | The parties dismiss all claims, counterclaims, and defenses with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Bayer Pharma AG v. Hetero Labs Ltd., 25-0754 (D. Del.) | Xarelto® (rivaroxaban tablets) | 10,828,310 | The parties dismiss all claims, counterclaims, and defenses with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Bayer Pharma AG v. Mylan Pharms. Inc., 21-1742, 22-1228 (D. Del.) | Xarelto® (rivaroxaban tablets) | 10,828,310 | The parties dismiss all claims, counterclaims, and defenses with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Bayer Pharma AG v. Lupin Ltd., 21-0314, 24-0138 (D. Del.) | Xarelto® (rivaroxaban tablets) | 10,828,310 | The parties dismiss all claims, counterclaims, and defenses with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Bayer Pharma AG v. Dr. Reddy’s Labs., Inc., 21-0732, 23-0410 (D. Del.) | Xarelto® (rivaroxaban tablets) | 10,828,310 | The parties dismiss all claims, counterclaims, and defenses with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Intra-Cellular Therapies, Inc. v. Dr. Reddy’s Labs. Inc., 24-4314, 24-8850, 24-4264, 24-10236 (D.N.J.) | Caplyta® (lumateperone capsules) | RE48,839 9,168,258 9,616,061 10,117,867 8,648,077 9,199,995 RE48,825 10,464,938 9,956,227 10,960,009 11,026,951 11,753,419 11,980,617 12,070,459 12,409,176 12,410,195 12,090,155 12,122,792 12,128,043 |
DRL admits that the claims of the patents-in-suit are valid and enforceable and one or more claims thereof would be infringed by the manufacture and sale of its ANDA product. DRL is enjoined from infringing the patents-in-suit until the expiration of the patents-in-suit, other than as authorized by ITCI. All affirmative defenses, claims, and counterclaims, which have been brought or could have been raised by the parties with respect to the patents-in-suit are dismissed with prejudice. The parties shall bear their own fees and costs, including attorneys’ fees. The parties waive any right to appeal. |
| Boehringer Ingelheim Pharms. Inc. v. Ipca Labs. Ltd., 25-1207 (D. Del.) | Jardiance® (empagliflozin tablets) | 11,090,323 11,833,166 |
Unless authorized or otherwise modified between the parties, Ipca is enjoined from infringing the patents-in-suit until their expiration. Nothing prohibits Ipca from maintaining or filing a PIV Certification with respect to the patents-in-suit. All remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attomey fees to any party. |
| Adverio Pharma GmbH v. Teva Pharms., Inc., 25-0479 (D. Del.) | Verquvo® (vericiguat tablets) | 8,420,656 8,921,377 9,604,948 9,993,476 10,736,896 11,439,642 |
All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Amicus Therapeutics US, LLC v. Aurobindo Pharma Ltd., 22-1461, 22-1467, 24-0698, 24-1331 (D. Del.) | Galafold® (migalastat capsules) | 11,633,388 11,833,164 12,042,490 |
Aurobindo acknowledges Amicus’s ownership and standing to sue on the patents-in-suit. Aurobindo acknowledges that the patents-in-suit are valid and enforceable. Aurobindo acknowledges that it has infringed the patents-in-suit under 35 U.S.C. § 271(e)(2) and that Amicus did not authorize said infringement. Aurobindo is permanently enjoined from infringing the patents-in-suit without a license granted by Amicus or under 35 U.S.C. § 271(e)(1). All claims are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. |
| Ascerta Pharma B.V. v. MSN Pharms. Inc., 25-0043 (D. Del.) | Calquence® (acalabrutinib maleate tablets) | 10,272,083 11,059,829 |
Except as authorized by the settlement agreement, MSN is enjoined from infringing the patents-in-suit. The 30-month stay with respect to the approval of MSN’s ANDA is terminated. Nothing prohibits MSN from maintaining PIV Certification(s) with respect to its ANDA product. All claims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees. |
| Bausch & Lomb Inc. v. Gland Pharma Ltd., 25-3398 (D.N.J.) | Lumify® (brimonidine tartrate ophthalmic solution) | 8,293,742 9,259,425 11,596,600 11,833,245 |
All claims, defenses, and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. |
| Amicus Therapeutics US, LLC v. Lupin Ltd., 23-0964 (D. Del.) | Galafold® (migalastat capsules) | 11,633,388 11,833,164 12,042,490 |
Lupin acknowledges that it has infringed the patents-in-suit under 35 U.S.C. § 271(e)(2) and that Amicus did not authorize said infringement. Lupin is permanently enjoined from infringing the patents-in-suit without a license granted by Amicus or under 35 U.S.C. § 271(e)(1). All claims are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. |
| Exelixis, Inc. v. Sun Pharm. Indus. Ltd., 25-0423 (D. Del.) | Cabometyx® (cabozantinib tablets) | 12,128,039 | All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party. |
| Janssen Pharms., Inc. v. Sun Pharm. Indus. Ltd., 25-13061 (D.N.J.) | Invega Sustenna® (palperidone palmitate extended-release injectable suspension) | 9,439,906 | For purposes of settling this case, Sun admits that the patent-in-suit is valid and enforceable, and that its claims would be infringed by making and selling its ANDA product. Unless otherwise authorized by Janssen, Sun is enjoined from infinging the patent-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Otsuka Pharm. Co., Ltd. v. Sun Pharm. Indus. Ltd., 24-0740 (D. Del.) | Jynarque® (tolvaptan tablets) | 8,501,730 10,905,694 8,273,735 |
The parties stipulate that all claims, counterclaims and affirmative defenses, are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party. |
