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 |
| Merck Sharp & Dohme LLC v. Aurobindo Pharma Ltd., 25-0449 (D. Del.) | Janumet XR® (metformin HCl / sitagliptin phosphate extended-release tablets) | 7,326,708 | Unless authorized by the settlement agreements, Aurobindo is enjoined from infringing 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. |
| Bayer Intellectual Property GmbH v. Mankind Pharma Ltd., 22-5599 (D.N.J.) | Xarelto® (rivaroxaban tablets) | 9,539,218 | Plaintiffs’ action against Mankind is hereby dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Intra-Cellular Therapies, Inc. v. Hetero USA, Inc., 24-4317, 24-0852, 24-10237 (D.N.J.) | Caplyta® (lumateperone capsules) | RE48,839 8,648,077 9,956,227 10,960,009 11,026,951 11,980,617 12,090,155 10,070,456 11,753,419 12,122,792 12,128,043 |
Hetero admits that the claims of the patents-in-suit are valid and enforceable with respect to products containing lumateperone distributed under Hetero’s ANDA and that the claims would be infringed by making and selling Hetero’s ANDA product. Hetero is enjoined from infringing the patents-in-suit until their expiration. All affirmative defenses, claims, and counterclaims, which have been or could have been raised are dismissed with prejudice. The parties shall bear their own costs and fees, including attorneys’ fees. The parties waive all right to appeal. |
| Astellas Pharma Inc. v. Ascent Pharms., Inc., 25-0035 (D.N.J.) | Xtandi® (enzalutamide tablets) | 7,709,517 8,183,274 12,161,628 |
Claims and counterclaims are dismissed with prejudice. Parties to bear their own costs. |
| Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 25-3790 (D.N.J.) | Yupelri® (revefenacin oral inhalation solution) | 12,285,417 | All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Eugia and Aurobindo, except as licensed by Plaintiffs, will be enjoined from infringing the ’417 patent until its expiration. Nothing shall prevent FDA from granting final approval to Eugia’s ANDA. Each party will bear its own attorneys’ fees and costs. |
| Novartis Pharms. Corp. v. Eugia Pharma Specialities Ltd., 25-0800 (D. Del.) | Tasigna® (nilotinib HCl capsules) | 8,163,904 8,293,756 8,389,537 8,415,363 8,501,760 9,061,029 |
All claims dismissed without prejudice. Each party will bear its own attorneys’ fees and costs. |
| Fresenius Kabi USA, LLC v. Endo Operations Ltd., 25-2861 (D.N.J.) | levothyroxine sodium injection | 9,782,376 10,398,669 11,135,190 |
Fresenius voluntarily dismissed the action without costs or attorney’s fees to any party. |
| Vifor (Int’l) AG v. Dr. Reddy’s Labs., Ltd., 24-6833 (D.N.J.) | Injectafer® (ferric carboxymaltose injection) | 7,612,109 7,754,702 8,895,612 11,364,260 11,433,091 11,478,502 |
All claims, counterclaims, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. The parties each expressly waive any right to appeal. |
| Pfizer Inc. v. Macleods Pharms. Ltd., 25-0632 (D. Del.) | Xeljanz® (tofacitinib tablets) | RE41,783 | All claims dismissed without prejudice. |
| American Regent, Inc. v. Endo Operations Ltd., 25-11945 (D.N.J.) | Tralement® (trace elements zinc sulfate / cupric sulfate / manganese sulfate / selenious acid 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 or by 35 U.S.C. § 271(e)(1), Endo is enjoined from infringing 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. Each party shall bear its own costs, expenses, and attorneys’ fees. Nothing shall preclude FDA from granting final approval to Endo’s ANDA or shall preclude Endo from filing, modifying, or maintaining with the FDA any Paragraph IV Certification for the Endo products. |
| Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Ltd., 25-4282 (D.N.J.) | Mayzent® (siponimod tablets) | 8,492,441 11,944,602 |
All claims dismissed without prejudice. Each party will bear its respective attorneys’ fees and costs. |
| Shionogi & Co., Ltd. v. Norwich Pharms., Inc., 23-0161, 24-1264 (D. Del.) | Xofluza® (baloxavir marboxil tablets) | 8,927,710 8,987,441 9,815,835 10,392,406 10,633,397 10,759,814 11,261,198 11,306,106 12,064,438 |
Except as authorized pursuant to the settlement agreement, Defendants are enjoined from infringing the patents-in-suit until the earlier of the Entry Date as defined by the agreement or the expiration of the patents-in-suit. Defendants admit that the submission of its ANDA was an act of infringement of the patents-in-suit under 35 U.S.C. § 271(e)(2)(a) and (b), and the patents-in-suit would be infringed by the making and sale of the ANDA product. Nothing prevents Defendants from maintaining their Paragraph IV certifications to the patents-in-suit. The 30-month stay with respect to approval of Norwich’s ANDA is terminated. The dismissal is without prejudice to any claim, defense, or counterclaim in any future action that does not concern the Norwich ANDA. All other claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Biogen Inc. v. Zydus Worldwide DMCC, 23-0732 (D. Del.) | Vumerity® (diroximel fumarate delayed-release capsules) | 8,669,281 9,090,558 10,080,733 |
All claims and defenses asserted by any party are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| AstraZeneca AB v. Apotex Inc., 24-0551 (D. Del.) | Xigduo XR® (dapagliflozin / metformin HCl extended-release tablets) | 7,919,598 8,501,698 8,685,934 9,616,028 |
Claims and amended counterclaims are dismissed without prejudice with each party to bear its own costs and fees. |
| Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of New York, LLC, 23-20964 (D.N.J.) | ProAir® HFA (albuterol sulfate inhalation aerosol) | 8,132,712 9,463,289 9,808,587 10,561,808 10,695,512 11,395,889 |
All claims, defenses, and counterclaims are dismissed, without prejudice. Each party shall bear its own costs. |
| Boehringer Ingelheim Pharms. Inc. v. Sun Pharm. Industries Ltd., 18-1765, 19-1500, 20-1153, 20-1585, 21-1487, 21-1573 (D. Del.) | Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) Synjardy® XR (empagliflozin / metformin extended release tablets) Trijardy XR® (empagliflozin / linagliptin / metformin extended release tablets) | 7,713,938 8,551,957 9,949,998 10,258,637 9,155,70 9,415,016 10,022,379 10,406,172 10,596,120 7,579,449 11,090,323 |
The patents-in-suit are valid, enforceable, and infringed by the Sun ANDA products. Nothing precludes Sun from challenging the validity, enforceability, and/or infringement of the patents-in-suit in connection with a product other than the Sun ANDA products. Unless specifically authorized, Sun 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 to incorporate such specified exclusivity. All remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Array BioPharma Inc. v. Teva Pharms., Inc., 23-0625 (D. Del.) | Mektovi® (binimetinib tablets) | 9,562,016 9,598,376 9,980,944 |
All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs and fees. |
| American Regent, Inc. v. Amneal Pharms. of NY, LLC, 25-2642 (D.N.J.) | Tralement® (trace elements zinc sulfate / cupric sulfate / manganese sulfate / selenious acid injection) | 11,786,548 11,975,022 11,998,565 12,150,956 12,150,957 |
Unless specifically authorized by ARI pursuant to the settlement agreement or by 35 U.S.C. § 271(e)(1), Amneal is enjoined from infringing 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 Amneal’s ANDA or shall preclude Amneal from filing, modifying, amending, recertifying, or maintaining with the FDA any Paragraph IV Certification for the Amneal Product. |
| American Regent, Inc. v. BPI Labs, LLC, 25-4439 (D.N.J.) | Selenious Acid | 11,998,565 12,150,957 |
Unless specifically authorized by ARI pursuant to the settlement agreement or by 35 U.S.C. § 271(e)(1), BPI is enjoined from infringing 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 BPI’s ANDA or shall preclude BPI from filing, modifying, or maintaining with the FDA any Paragraph IV Certification for the BPI Product. |
| AbbVie Inc. v. Hetero USA, Inc., 25-0190 (D. Del.) | Rinvoq® (upadacitinib extended-release tablets) | 11,607,411 11,564,922 |
The filing of Hetero’s ANDA was an act of infringement of the patents-in-suit under 35 U.S.C. § 271(e)(2)(A). All other claims, counterclaims, and defenses are dismissed, without prejudice. Hetero is enjoined from infringing the patents-in-suit, absent authorization by AbbVie. 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 Hetero and AbbVie regarding the patents-in-suit and a product other than Hetero’s ANDA products. |
| Aragon Pharms., Inc. v. Lupin Ltd., 25-2860 (D.N.J.) | Erleada® (apalutamide tablets) | 11,963,952 | Plaintiffs voluntarily dismiss the action without prejudice. No defendant has served an answer or a motion for summary judgment. |
| HQ Specialty Pharma Corp. v. Amneal Pharms. LLC, 23-1135 (D. Del.) | calcium gluconate in sodium chloride for injection | 10,130,646 | All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. Amneal is enjoined from infringing the patents-in-suit during the term of the patent-in-suit, unless licensed by Plaintiffs. Plaintiffs’ claims for damages based on the sales of the Amneal Products prior to Aug. 8, 2025 are hereby waived. The stipulation and consent judgment shall not act as an adjudication on the merits. |
| Salix Pharms., Inc. v. SABA Ilac Sanayi ve Ticaret A.S., 25-2307 (D.N.J.) | Xifaxan® (rifaximin tablets) | 11,564,912 11,779,571 8,193,196 7,928,115 |
All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees. Saba is entitled to maintain its Paragraph IV certifications to U.S. Patent Nos. 7,928,115, 8,193,196, 8,642,573, 8,309,569, 8,829,017, 8,946,252, 8,969,398, 10,456,384, 10,456,384, 10,765,667, 11,564,912, and 11,779,571. The 30-month stay with respect to the approval of the Saba ANDA is terminated. |
| Salix Pharms., Inc. v. Alkem Labs. Ltd., 25-9344 (D.N.J.) | Xifaxan® (rifaximin tablets) | 11,779,571 11,564,912 8,193,196 |
All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees. Alkem is entitled to maintain its Paragraph IV certifications to U.S. Patent Nos. 7,928,115, 8,193,196, 8,642,573, 8,309,569, 8,829,017, 8,946,252, 8,969,398, 10,456,384, 10,456,384, 10,765,667, 11,564,912, and 11,779,571. The 30-month stay with respect to the approval of the Alkem ANDA is terminated. |
| Salix Pharms., Inc. v. Zydus Pharms. (USA) Inc., 24-9512 (D.N.J.) | Xifaxan® (rifaximin tablets) | 11,779,571 11,564,912 8,193,196 8,518,949 8,741,904 9,271,968 10,703,763 |
All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees. Zydus is entitled to maintain its Paragraph IV certification to U.S. Patent Nos. 8,193,196, 8,309,569, 8,518,949, 8,741,904, 9,271,968, 10,456,384, 10,703,763, 10,765,667, 11,564,912, and 11,779,571. The 30-month stay with respect to the approval of the Zydus ANDA is terminated. |
| Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 23-0926 (D.N.J.) | Yupelri® (revefenacin inhalation solution) | 8,541,451 8,017,783 9,249,099 9,765,028 10,100,013 10,550,081 11,008,289 11,484,531 11,649,209 11,691,948 11,858,898 12,048,692 12,285,417 |
All claims, counterclaims, and affirmative defenses assertdd by the parties are dismissed without prejudice. Cipla, except as licensed or otherwise permitted by plaintiffs, will be enjoined until expiration of hte patents-in-suit from infringing the patents-in-suit. Nothing shall prevent FDA from granting final approval to Cipla’s ANDA. Each party shall bear its own costs and attorneys’ fees. |
| Catalyst Pharms., Inc. v. Lupin Ltd., 23-1197 (D.N.J.) | Firdapse® (amifampridine tablets) | 10,626,088 10,793,893 11,060,128 11,268,128 11,274,331 11,274,332 |
Unless authorized by Plaintiffs pursuant to the settlement agreement or by 35 U.S.C. § 271(e)(1), Lupin agrees not to infringe the patents-in-suit. All remaining claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall preclude FDA from granting final approval at any time to Lupin’s ANDA. |
| Allergan Holdings Unlimited Co. v. MSN Labs. Private Ltd., 24-1187 (D. Del.) | Viberzi® (eluxadoline tablets) | 11,484,527 12,097,187 |
The filing of MSN’s ANDA was an act of infringement of the patents-in-suit under 35 U.S.C. § 271(e)(2)(A). All other claims, counterclaims, and defenses are dismissed without prejudice. MSN is enjoined from infringing the patents-in-suit during the life of the patents-in-suit, absent a license or other authorization by Plaintiffs. The parties waive any right to appeal. This stipulation and order is without prejudice to any claim, defense, or counterclaim in any possible future action between MSN and any of the Plaintiffs regarding th patents-in-suit and a product other than the MSN ANDA product. Nothing prohibits MSN from engaging in activity permitted under 35 U.S.C. § 271(e)(1). |
| Boehringer Ingelheim Pharms. Inc. v. Granules India Ltd., 25-0663 (D. Del.) | Jardiance® (empagliflozin tablets) | 9,949,998 10,258,637 11,090,323 11,833,166 |
Plaintiff Boehringer lngelheim Corp. is dismissed with prejudice. The patents-in-suit are valid and enforceable with respect to the Granules ANDA product. Granules ANDA product infringes the patents-in-suit absent Boehringer’s authorization. Unless specifically authorized, Granules is enjoined from infringing the paents-in-suit until the expiration of the patents-in-suit. If Boehringer becomes entitled to any other regulatory exclusivities, Boehringer may apply to the Court for modification of the consent judgment to incorporate such specified exclusivity. The parties shall bear their own fees and costs, including attorneys’ fees. All remaining claims, counterclaims, or affirmative defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Gilead Sciences, Inc. v. Lupin Ltd., 22-0615 (D. Del.) | Biktarvy® (bictegravir sodium / tenofovir alafenamide fumarate / emtricitabine tablets) | 9,708,342 10,385,067 10,548,846 |
All affirmative defenses, claims, and counterclaims are dismissed without prejudice. The claims of the patents-in-suit are valid and enforceable with respect to Lupin’s ANDA. Unless authorized by Gilead, Lupin is enjoined from infringing the patents-in-suit until their expiration. The parties waive all right to appeal. Each party is to bear its own costs and attorneys’ fees. Nothing (a) shall prevent FDA from granting final, effective approval to Lupin’s ANDA, and (b) applies to any product or application other than the product that is the subject of Lupin’s ANDA. |
| Gilead Sciences, Inc. v. Lupin Ltd., 22-0615 (D. Del.) | Biktarvy® (bictegravir sodium / tenofovir alafenamide fumarate / emtricitabine tablets) | 9,708,342 11,744,802 |
All affirmative defenses, claims, and counterclaims are dismissed without prejudice. The claims of the patents-in-suit are valid and enforceable with respect to Laurus’s ANDA. Except as agreed to by the parties, Laurus is enjoined from infringing the patents-in-suit until the date agreed by and between the parties. The parties waive all right to appeal. Each party is to bear its own costs and attorneys’ fees. Nothing shall be prevent FDA from granting final, effective approval to Laurus’s ANDA. |
| Athena Bioscience, LLC v. Novitium Pharma LLC, 24-1421 (D. Del.) | Qdolo® (tramadol HCl oral solution) | 11,103,452 11,752,103 |
All claims, counterclaims, and defenses are dismissed with each side to bear its own costs, expenses, and attorneys’ fees. |
| Bristol-Myers Squibb Co. v. Synthon BV, 24-0780 (D. Del.) | Zeposia® (ozanimod capsules) | 11,680,050 | All claims and counterclaims, defenses, motions, and petitions are dismissed without prejudice and the dismissal is not an adjudication on the merits. Each party shall bear its own costs and attorneys’ fees. The parties waive any right to appeal. |
| Exelixis, Inc. v. Biocon Pharma Ltd., 25-0452 (D. Del.) | Cabometyx® (cabozantinib (S)-malate tablets) | 8,877,776 11,091,439 11,091,440 11,098,015 12,128,039 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party. |
| Pfizer Inc. v. Orient Pharma Co., Ltd., 25-0743 (D. Del.) | Xeljanz® XR (tofacitinib citrate extended-release tablets) | 9,937,181 10,639,309 11,253,523 |
All claims are dismissed without prejudice. |
| AbbVie Inc. v. Aurobindo Pharma USA, Inc., 23-1332, 24-0924, 24-1254, 25-0422 (D. Del.) | Rinvoq® (upadacitinib extended-release tablets) | 9,951,0800 10,981,923 11,186,584 11,661,425 11,680,069 11,718,627 11,198,697 9,963,459 10,344,036 10,519,164 10,730,883 10,981,924 10,597,400 11,535,624 10,995,095 10,550,126 11,535,625 11,535,626 11,365,198 11,512,092 11,524,964 11,767,326 11,773,105 11,773,106 11,780,847 11,780,848 11,787,815 11,795,175 11,976,077 11,993,605 11,993,606 9,879,018 |
The filing of Aurobindo’s ANDA was an act of infringement of the patents-in-suit under 35 U.S.C. § 271(e)(2)(A). All other claims, counterclaims, and defenses are dismissed, without prejudice. Aurobindo is enjoined from infringing the patents-in-suit during the life of the patents-in-suit, including any extensions and pediatric exclusivities, absent a license agreement or other authorization by Abbvie. The parties waive any right to appeal. The dismissal is without prejudice to any claim, defense, or counterclaim in any possible future actions between the parties regarding the patents-in-suit and a product other than Aurobindi’s ANDA product. |
| Celgene Corp. v. Cipla Ltd., 25-1147 (D.N.J.) | Pomalyst® (pomalidomide capsules) | 8,828,427 9,993,467 10,555,939 |
Until expiration of the patents-in-suit, Cipla is enjoined from infringing the patents-in-suit, unless otherwise specifically authorized by Celgene. All claims, counterclaims, affirmative defenses, and demands pertaining to the Patents-in-Suit are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. Nothing prohibits Cipla from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing prohibits Cipla from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving Cipla’s ANDA. |
| Braintree Labs., Inc. v. Appco Pharma LLC, 25-10876 (D.N.J.) | Sutab® (sodium sulfate / magnesium sulfate / potassium chloride osmotic laxative tablets) | 10,143,656 11,033,498 11,382,864 11,638,697 |
Plaintiffs dismiss without prejudice their complaint, with each party to bear its own costs and fees. |
| Teva Branded Pharm. Products R&D, Inc. v. Cipla USA, Inc., 24-0909, 24-5856, 24-7162, 24-9691 (D.N.J.) | Qvar RediHaler® (beclomethasone dipropionate inhalation aerosol) | 8,132,712 8,931,476 10,022,509 10,022,510 10,086,156 10,561,808 10,695,512 10,792,447 11,395,888 11,395,889 11,559,637 11,583,643 11,793,953 11,865,247 11,896,759 11,957,832 |
All claims, defenses, and counterclaims are dismissed without prejudice. Each party shall bear its own costs. |
| American Regent, Inc. v. Sun Pharm. Indus. Ltd., 24-7810 (D.N.J.) | Selenious Acid | 11,998,565 12,150,957 |
Unless otherwise authorized by ARI pursuant to the settlement agreement or by 35 U.S.C. § 271(e)(1), Sun is enjoined from infringing 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 Sun’s ANDA or shall preclude Sun from filing, modifying, or maintaining with FDA any Paragraph IV Certification for the Sun ANDA product. |
| Oyster Point Pharma, Inc. v. Apotex, Inc., 23-3860 (D.N.J.) | Tyrvaya® (varenicline solution) | 9,504,644 9,504,645 9,532,944 9,597,284 10,456,396 11,224,598 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Apotex is enjoined until expiration of the patents-in-suit from infringing the patents-in-suit. Each party will bear its own attorneys’ fees and costs. |
| Astellas Pharma Inc. v. Deva Holding A/S, 25-0233 (D. Del.) | Myrbetriq® (mirabegron extended-release tablets) | 10,842,780 11,707,451 12,059,409 12,097,189 |
Pursuant to the parties’ settlement and license agreement, the parties request that the court dismiss all claims between 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. |
| Eisai R&D Management Co., Ltd. v. Dr. Reddy’s Labs., Inc., 24-6765 (D.N.J.) | Lenvima® (lenvatinib mesylate capsules) | 7,612,208 10,407,393 11,186,547 |
DRL agrees that the patents-in-suit are valid and enforceable with respect to the DRL ANDA product and any generic equivalent. Except as authorized under the settlement agreement, DRL is enjoined from infringing the patents-in-suit prior to the expiration of 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. |
