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 |
| Bausch & Lomb Inc. v. Granules India Ltd., 25-18325 (D.N.J.) | Lumify® (brimonidine tartrate ophthalmic solution) | 8,293,742 9,259,425 11,596,600 11,833,245 |
Until expiration of the patents-in-suit, Granules is enjoined from infringing the patents-in-suit, unless otherwise specifically authorized by Plaintiffs. All claims, counterclaims, affirmative defenses, motions, and petitions are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Granules from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing prohibits Granules from engaging in any activity permitted under 35 U.S.C. § 271(e)(l). Nothing restricts FDA from approving Granules ANDA product. |
| Vifor (Int’l) AG v. MSN Labs. Private Ltd., 25-3286 (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 waive any right to appeal or otherwise move for relief from the stipulation and order. Nothing restricts FDA from approving MSN’s ANDA. Plaintiffs take no position on MSN maintaining a “Paragraph IV Certification” to the patents-in-suit after the entry of the stipulation and order of dismissal. |
| Veloxis Pharms., Inc. v. Sun Pharm. Indus. Ltd., 24-0726 (D. Del.) | Envarsus XR® (tacrolimus extended-release tablets) | 8,685,99 9,549,918 10,166,190 10,864,199 11,110,081 11,123,331 11,419,823 |
Until expiration of the patents-in-suit, Sun is enjoined from infringing or assiting any third party from infringing the patents-in-suit, unless specifically authorized by Veloxis. All remaining claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. This dismissal does not foreclose Sun from raising invalidity or non-infringement defenses in another action relating to the patents-in-suit relating to a product other than the Sun ANDA product. Nothing prohibits Sun from maintaining a “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving the Sun ANDA product at any time. |
| Vifor Fresenius Medical Care Renal Pharma Ltd. v. MSN Labs. Private Ltd., 25-1440 (D. Del.) | Korsuva® (difelikefalin acetate injection) | 7,402,564 | Unless otherwise authorized pursuant to the settlement agreement, MSN is enjoined from infringing the ’564 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits MSN from maintaining a “Paragraph IV Certification” for the MSN ANDA product. Nothing restricts FDA from approving MSN’s ANDA product. |
| Bausch Health Ireland Ltd. v. MSN Labs. Private Ltd., 24-11179 (D.N.J.) | Trulance® (plecanatide tablets) | 12,146,003 | Complaints and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees. Bausch acknowledges that MSN is entitled to maintain its Paragraph IV certification to the Orange Book-listed patents. Each party agrees that the 30-month stay with respect to the approval of the MSN ANDA is terminated. |
| Aurobindo Pharma Ltd. v. Azurity Pharms. Inc., 26-0265 (D. Del.) | Horizant® (gabapentin enacarbil extended-release tablets) | 8,795,725 | Aurobindo dismisses its complaint without prejudice. |
| AstraZeneca AB v. Sun Pharm. Industries Ltd., 23-1383 (D. Del.) | Farxiga® (dapagliflozin tablets) | 6,515,117 | All claims and defenses are dismissed without prejudice. The parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Pharmacosmos A/S v. Teva Pharms., Inc., 25-3218 (D.N.J.) | Cosela® (Trilaciclib injection) | 11,529,352 12,168,666 |
All claims, counterclaims, and defenses are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Otsuka Pharm. Co., Ltd. v. Alvogen, Inc., 25-0188 (D. Del.) | Abilify Maintena® (aripiprazole injection) | 10,525,057 10,980,803 11,154,553 11,344,547 11,400,087 11,648,347 |
All claims and counterclaims are dismissed, without prejudice, with the parties to bear their own costs and attorneys’ fees. |
| Impax Labs., LLC v. Qilu Pharm. (Hainan) Co., Ltd., 25-3292 (D.N.J.) | Rytary® (carbidopa / levodopa extended-release capsules) | 8,557,283 9,089,608 9,463,246 9,533,046 9,901,640 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Nothing shall prevent Qilu from maintaining a Paragraph IV certification in Qilu’s ANDA to the patents-in-suit or prohibit FDA from granting final approval to Qilu’s ANDA. Each party shall bear its own attorneys’ fees and costs. |
| Gilead Sciences, Inc. v. Aspiro Pharma Ltd., 25-13936 (D.N.J.) | Veklury® (remdesivir injection) | 10,675,296 11,266,681 11,975,017 11,491,169 11,903,953 11,975,012 |
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 Hetero ANDA product. Except as agreed by the parties, Hetero is enjoined from infringing the patents-in-suit until the date agreed to by the parties. The parties waive all right to appeal. Each party is to bear its own costs and attorneys’ fees. Nothing (a) shall be construed as preventing FDA from granting final, effective approval to the Hetero ANDA, and (b) applies to any product or application other than the product or application that is the subject of the Hetero ANDA. |
| Azurity Pharms., Inc. v. Aurobindo Pharma Ltd., 25-1507 (D. Del.) | Edarbi® (azilsartan kamedoxomil tablets) | 9,066,936 | All claims and counterclaims are dismissed without prejudice. Any protective orders entered by the court shall remain in full force and effect notwithstanding the dismissal of this action. Each party shall bear its own costs and attorneys’ fees. This stipulation shall not act as an adjudication on the merits. |
| Pfizer Inc. v. Aurobindo Pharma Ltd., 23-0923, 23-1182 (D. Del.) | Vyndaqel® (tafamidis meglumine capsules) | 7,214,695 7,214,696 |
Pfizer’s action against Aurobindo is dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Pfizer Inc. v. Dexcel Pharma Tech. Ltd., 23-0879 (D. Del.) | Vyndamax® (tafamidis capsules) | 7,214,695 7,214,696 |
Court grants partial judgment in favor of Plaintiffs that Dexcel’s ANDA infringes the ’695 and ’696 patents. Final FDA approval of Dexcel’s ANDA is reset to the expiry of the the ’695 and ’696 patents. Dexcel is enjoined from infringing the ’695 and ’696 patents until their expiration. Partial consent judgment does not limit any party’s assertion of other claims of defenses, other than those regarding the ’695 and ’696 patents. Partial consent judgment is not a final judgment with respect to the ’441 patent, which is still pending adjudication. |
| Pfizer Inc. v. Dexcel Pharma Tech. Ltd., 23-0879 (D. Del.) | Vyndamax® (tafamidis capsules) | 7,214,695 7,214,696 9,770,441 |
Pfizer’s action against Dexcel is dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Pfizer Inc. v. Cipla Ltd., 23-0909 (D. Del.) | Vyndamax® (tafamidis capsules) | 9,770,441 | Pfizer’s action against Cipla is dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Actelion Pharms. US, Inc. v. Apotex Inc., 25-1488 (D. Del.) | Uptravi® (selexipag tablets) | 8,791,122 9,284,280 |
Apotex agrees the patents-in-suit are valid and enforceable. Unless otherwise authorized by Plaintiffs, Apotex is enjoined from infringing the patents-in-suit until their expiration. Parties waive all right to appeal. Claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees. |
| Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 26-0232 (D. Del.) | Jynarque® (tolvaptan tablets) | 10,905,694 8,273,735 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Almirall, LLC v. Taro Pharms., Inc., 25-0385 (D. Del.) | Klisyri® (tirbanibulin topical ointment) | 7,300,931 7,851,470 10,323,001 10,617,693 10,669,236 11,497,750 |
All claims and counterclaims between the parties are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. The parties have entered into a settlement agreement with respect to their respective claims. Taro will not infringe the patents-in-suit, except as according to the parties’ settlement agreement. This stipulation and order shall not act as an adjudication on the merits. |
| Taiho Pharm. Co., Ltd. v. MSN Labs. Private Ltd., 23-0008 (D. Del.) | Lonsurf® (tipiracil HCl / trifluridine tablets) | 10,960,004 | All claims, counterclaims, and defenses are dismissed with prejudice. Each party shall bear its own costs and attorneys’ fees. |
| Sumitomo Pharma Switzerland GmbH v. Sandoz Inc., 25-0970 (D. Del.) | Orgovyx® (relugolix tablets) | 11,795,178 12,325,714 12,097,198 12,144,809 12,336,990 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party. No action (other than C.A. No. 25-970 (MN)) in these consolidated matters is affected by the stipulation and order of dismissal without prejudice. |
| Pfizer Inc. v. Zenara Pharma Private Ltd., 23-0924 (D. Del.) | Vyndamax® (tafamidis capsules) | 9,770,441 | Pfizer’s action agaisnt Hikma is dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| AstraZeneca Pharms. LP v. Sandoz Inc., 24-0641, 24-5889, 24-8164, 24-10627, 25-0231 (D.N.J.) | Lynparza® (olaparib tablets) | 7,449,464 8,475,842 8,859,562 11,633,396 11,970,530 11,975,001 12,048,695 12,144,810 12,178,816 |
Unless specifically authorized pursuant to the settlement agreement, Sandoz is 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. Matters against Natco, Cipla, and Zydus remain active. |
| Heron Therapeutics, Inc. v. Baxter Healthcare Corp., 25-1555 (D. Del.) | Cinvanti® (aprepitant injection) | 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 and counterclaims are dismissed with the parties to bear their own costs and attorneys’ fees. |
| Eagle Pharms., Inc. v. Baxter Healthcare Corp., 24-0066, 25-0079 (D. Del.) | Belrapzo® (bendamustine HCl injection) | 11,844,783 11,872,214 12,138,248 |
Eagle’s claims are dismissed with prejudice. Baxter’s counterclaims are dismissed as moot. All parties shall bear their own costs and attorneys’ fees. |
| Onyx Therapeutics, Inc. v. Hetero USA Inc., 26-0324 (D. Del.) | Kyprolis® (carfilzomib injection) | 7,737,112 | Hetero admits that the ’112 patent claims are valid and enforceable. The asserted claims would be infinged by the Hetero ANDA product. Until the experiation of the patent-in-suit, Hetero is enjoined from infringing the ’112 patent, except as specifically authorized by Onyx in writing. Onyx dismisses with prejudice all claims and demands, and without costs, disbursements, or attorneys’ fees to any party. |
| American Regent, Inc. v. Apotex, Inc., 24-2268, 24-1022 (D.N.J.) | Tralement® (trace elements injection 4*, USP) Multrys® (trace elements injection 4*, USP) | 11,786,548 | Unless otherwise authorized by ARI pursuant to the settlement agreement, Apotex is enjoined from infinging the patent-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 the Apotex ANDA or shall preclude Apotex from filing, modifying, or maintaining with the FDA any PIV Certification for the Apotex products. |
| Incyte Corp. v. Eugia Pharma Specialities Ltd., 25-17833 (D.N.J.) | Jakafi® (ruxolitinib tablets) | 7,598,257 8,415,362 8,722,693 8,822,481 8,829,013 9,079,912 |
Until expiration, Eugia is enjoined from infringing the patents-in-suit, unless otherwise authorized by Incyte. All claims, counterclaims, affirmative defenses, motions and petitions are dismissed with prejudice and without costs, disbursements, or attorneys’ fees. Nothing prohibits Eugia from maintaining any PIV Certification with respect to the patents-in-suit. Nothing prohibits Eugia from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving Eugia’s ANDA. |
| Aragon Pharms., Inc. v. Hetero Labs Ltd. Unit V, 26-0168 (D.N.J.) | Erleada® (apalutamide tablets) | 12,303,493 12,303,497 |
Hetero admits that the claims of the patents-in-suit are valid and enforceable with respect to the Hetero ANDA product, and would be infringed by the manufacture and use of the Hetero ANDA product on approval. Hetero is enjoined from infringing the patents-in-suit until their expiration, other than as authorized by Plaintiffs. All affirmative defenses, claims, and counterclaims, which have been or could have been raised by the parties with respect to the patents-in-suit as asserted against the Hetero ANDA product are dismissed with prejudice. The parties shall bear their own fees and costs, including attorneys’ fees. The parties waive all right to appeal. |
| Catalyst Pharms., Inc. v. Annora Pharma Private Ltd., 23-1194 (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, Hetero agrees not to infringe 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 Hetero’s ANDA. |
| Janssen Pharms., Inc. v. Tolmar, Inc., 21-1784 (D. Del.) | Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) | 9,439,906 | The march 13, 2024, final judgment is vacated and superseded by this Consent Judgment and shall have no preclusive effect. Tolmar admits that all claims of the ’906 patent are valid and enforceable, and would be infringed by the Tolmar ANDA Product prior to expiration of ’906 patent. Unless specifically authorized by Janssen, Tolmar is enjoined from infringing the ’906 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall prevent FDA from granting final approval to the Tolmar ANDA Product at any time. |
| HQ Specialty Pharma Corp. v. Cipla Ltd., 25-1236 (D. Del.) | calcium gluconate in sodium chloride injection | 10,130,646 | All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. Defendants are enjoined from infringing the ’646 patent with respect to its ANDA product, unless licensed by plaintiffs. The stipulation and consent judgment shall not act as an adjudication on the merits. Nothing prohibits defendants from maintaining, modifying or filing any “Paragraph IV Certification” with respect to the Cipla ANDA products or any application therefore. Nothing prohibits any party from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). |
| Vifor (Int’l) AG v. Xiromed Pharma Espana, S.L., 25-17822 (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 expressly waive any right to appeal or otherwise move for relief from the dismissal. |
| Adverio Pharma GmbH v. Changzhou Pharm. Factory, 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 |
Plaintiffs’ action against Annora/Hetero, including all claims and defenses, is dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
| Vifor Fresenius Medical Care Renal Pharma Ltd. v. Gland Pharma Ltd., 25-1382 (D. Del.) | Korsuva® (difelikefalin acetate injection) | 7,402,564 7,713,937 7,727,963 8,217,007 8,236,766 8,486,894 8,536,131 9,334,305 9,359,399 10,017,536 10,138,270 10,793,596 |
Unless otherwise authorized pursuant to the settlement agreement, Somerset is 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. Nothing prohibits Somerset from maintaining a “Paragraph IV Certification” for the Somerset ANDA product. Nothing restricts FDA from approving Somerset’s ANDA product. |
| Incyte Corp. v. Alkem Labs. Ltd., 26-2338 (D.N.J.) | Jakafi® (ruxolitinib tablets) | 8,722,693 8,822,481 8,829,013 |
Until expiration of the patents-in-suit, Alkem is enjoined from infringing the patents-in-suit, unless otherwise 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 Alkem from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing prohibits Alkem from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving Alkem’s ANDA or the Alkem ANDA product. |
| UroGen Pharma Ltd. v. Teva Pharms., Inc., 24-0417 (D. Del.) | Jelmyto® (mitomycin for pyelocalyceal solution) | 9,040,074 9,950,069 |
Each of parties’ claims and counterclaims is dismissed with prejudice. The parties are each to bear their own costs. |
| Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 25-17592, 26-1580 (D.N.J.) | Sunosi® (solriamfetol tablets) | 12,263,145 12,318,362 12,390,419 12,384,743 |
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to any party. The dismissal of these matters with respect to Aurobindo shall not result in the dismissal of any claims, defenses, and/or counterclaims with respect to any other defendant. |
| Boehringer Ingelheim Pharms. Inc. v. Ipca Labs. Ltd., 26-0336 (D. Del.) | Tradjenta® (linagliptin tablets) | 9,486,526 10,034,877 11,033,552 |
Ipca agrees that the patents-in-suit are valid and enforceable. Unless specifically authorized by plaintiffs or modified by the parties, Ipca is enjoined from infringing the patents-in-suit until their expiration, including any patent term extension, patent term adjustment, or other regulatory exclusivity that BI becomes entitled to. Nothing prohibits Ipca from maintaining and/or filing a “Paragraph IV Certification” with respect to the patents-in-suit. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party. |
| AbbVie Inc. v. Deva Holding A.S., 25-1332 (D. Del.) | Vraylar® (cariprazine capsules) | 7,737,142 7,943,621 RE47,350 RE49,110 RE49,302 |
The filing of Deva’s ANDA was a technical act of infringement of each of the patents-in-suit under 35 U.S.C. § 271(e)(2)(A). All other claims and defenses asserted by the parties are dismissed, without prejudice. Deva is enjoined from infringing the patents-in-suit until their expiration, including any extensions and pediatric exclusivities, absent a license agreement or other authorization by Plaintiffs, unless all of the claims of the patents-in-suit are found invalid or unenforceable by a court decision from which no appeal has been or can be taken. 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 Deva and any of the Plaintiffs regarding the patents-in-suit and a product other than the Deva ANDA product. |
| Purdue Pharma L.P. v. Elite Labs., Inc., 23-22221 (D.N.J.) | OxyContin® (oxycodone HCl extended-release tablets) | 9,763,933 9,770,416 9,492,389 9,492,391 9,492,392 9,492,393 9,775,808 11,304,908 11,304,909 9,073,933 9,522,919 10,407,434 9,775,811 9,763,886 11,298,322 |
Elite covenants to submit a Paragarph III certification that it is not seeking ANDA approval until the expiration of the patents-in-suit on Aug. 24, 2027. Should Elite sell and/or transfer its ANDA, it will privide notice to Purdue. All claims are dismissed without prejudice and without costs or attorneys’ fees. |
| Vifor (Int’l) AG v. Apotex Inc., 25-0211 (D. Del.) | 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 waive any right to appeal or otherwise move for relief. |
| HQ Specialty Pharma Corp. v. Sagent Pharms (Inc.), 25-1227 (D. Del.) | calcium gluconate in sodium chloride injection | 10,130,646 | All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. Sagent is enjoined from infringing the patent-in-suit until its expiration, unless licensed by Plaintiffs. The Stipulation and Consent Judgment shall not act as an adjudication on the merits. Nothing prohibits Sagent from maintaining, modifying, or filing any “Paragraph IV Certification” with respect to the Sagent Products or any application therefor. Nothing prohibits any party from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). |
| Baxter Healthcare Corp. v. PH Health Ltd., 25-15120 (D.N.J.) | Nexterone® (amiodarone HCl premixed injection) | 7,635,773 | All claims by all parties are dismissed without prejudice in its entirety. Each party shall bear its own costs, attorneys’ fees, and expenses incurred in connection with the claims dismissed by this stipulation. |
| Merck Sharp & Dohme LLC v. Zydus Pharms. (USA) Inc., 24-10820 (D.N.J.) | Prevymis® (letermovir tablets) | RE 46,791 | All claims, counter claims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. |
| Bausch & Lomb Inc. v. Saba Ilac Sanayi ve Ticaret A.S., 25-15127 (D.N.J.) | Vyzulta® (latanoprostene bunod ophthalmic solution) | 8,058,467 | All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party. |
| Vifor Fresenius Medical Care Renal Pharma Ltd. v. Cipla Ltd, 25-1420 (D. Del.) | Korsuva® (difelikefalin acetate injection) | 7,402,564 | Unless otherwise authorized by the settlement agreement, Cipla is enjoined from infringing the patent-in-suit and additional Orange Book-listed patents. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Cipla from maintaining a “Paragraph IV Certification” for the Cipla ANDA Product with respect to the Patent-in-Suit or any other patent listed in the FDA’s Orange Book for Korsuva solely for purposes of receiving or maintaining final approval of the Cipla ANDA Product. Nothing restricts Cipla from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from granting final approval to Cipla’s ANDA. |
| Aveo Pharms., Inc. v. Glenmark Pharms. Ltd., 25-0735 (D. Del.) | Fotivda® (tivozanib HCl capsules) | 11,504,365 7,166,722 |
All claims and counterclaims, and any defenses thereto, are dismissed without prejudice and without costs, on the terms set forth in the settlement agreement. Each party shall bear its own costs, expenses, and attorneys’ fees. The parties waive any right of appeal. |
| Intra-Cellular Therapies, Inc. v. Aurobindo Pharma Ltd., 24-4264, 24-8848, 24-10235 (D.N.J.) | Caplyta® (lumateperone capsules) | RE48,839 9,956,227 10,960,009 11,026,951 11,753,419 11,980,617 12,070,459 12,090,155 12,122,792 12,128,043 12,409,176 12,410,195 |
Aurobindo admits that the claims of the patents-in-suit are valid and enforceable with respect to the Aurobindo ANDA, and that the claims of the patents-in-suit would be infringed by the manufacture and sale of the Aurobindo ANDA product. Aurobindo is enjoined from infringing the patents-in-suit until their expiration, other than as authorized by ITCI. All affirmative defenses, claims, and counterclaims, which have been or could have been raised by the parties are dismissed with prejudice. The parties shall bear their own fees and costs, including attorneys’ fees. The parties waive all right to appeal. |
| Indivior Inc. v. Lupin Inc., 25-0757 (D. Del.) | Opvee® (nalmefene Nasal spray) | 11,458,091 12,290,596 |
Indivior’s s action is dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees. |
