ANDA Litigation Settlements Fall 2021 | Hatch-Waxman

Reported settlements in federal district court cases

Third Quarter

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
Corcept Therapeutics, Inc. v. Sun Pharma Global FZE, 19-15678 (D.N.J.)	Korlym® (mifepristone tablets)	8,921,348 9,829,495 10,195,214 10,500,216 10,842,800 10,842,801	All claims, defenses, and counterclaims are dismissed without prejudice. Until expiration of the patents-in-suit, Sun is enjoined from infringing the patents-in-suit unless specifically authorized by Corcept. Each party shall bear its own fees and costs, including attorneys’ fees.
Bausch Health US, LLC v. Zydus Pharms. (USA) Inc., 20-2748 (D.N.J.)	Jublia® (efinaconazole topical solution)	7,214,506 8,039,494 8,486,978 9,302,009 9,566,272 9,662,394 9,861,698 9,877,955 10,105,444 10,512,640 10,342,875 10,478,601	In the event that the claims of patents-in-suit are not held invalid or unenforceable, absent a license or other authorization from Plaintiffs, the patents-in-suit would be infringed by the efinaconazole product described in the Zydus ANDA. Zydus, except as expressly licensed or authorized by Plaintiffs, will be enjoined until expiration of the patents-in-suit from infringing the patents-in-suit. Zydus is entitled to contest the infringement, validity and/or enforceability of the patents-in-suit in any future litigation over the patents-in-suit pertaining pertaining to any product that is not the Zydus ANDA product. Each party will bear its own attorneys’ fees and costs. Zydus is entitled to maintain its Paragraph IV certification to the patents-in-suit pursuant to 21 C.F.R. § 314.94(a)(12)(v). The 30-month stay with respect to the approval of the Zydus ANDA product under 21 U.S.C. § 355(j)(5)(B)(iii) is terminated.
Astellas US LLC v. Glenmark Pharms. Ltd., 20-0516 (D. Del.)	Lexiscan® (regadenoson for injection)	8,106,183 RE 47,301 8,524,883	All claims and countercalims, defenses, motions, and petitions are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. The parties waive any right to appeal.
Ferring Pharms. Inc. v. Lupin Inc., 19-0913 (D. Del.)	Clenpiq® (sodium picosulfate / magnesium oxide / anhydrous citric acid oral solution)	9,827,231 9,669,110	Lupin admits that the asserted claims are valid and enforceable with respect to its ANDA product. Lupin admits that, absent a valid license to the patents-in-suit, its ANDA product infringes the patents-in-suit. Lupin is enjoined from infringing the patents-in-suit until their expiration. The consent decree and stipulation of dismissal do not constitute a judgment on the merits on any such claim or counterclaim. Ferring may not assert the entry of the consent decree and stipulation of dismissal against Lupin in an action concerning a product that is not the Lupin ANDA product. All affirmative defenses, claims, and counterclaims with respect to the Lupin ANDA are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Pfizer Inc. v. Natco Pharma, Inc., 19-0753 (D. Del.)	Ibrance® (palbociclib capsules)	6,936,612 7,208,489 7,456,168	All claims and affirmative defenses are dismissed without prejudice. Nothing shall prevent Natco from engaging in (i) activities covered by 21 U.S.C. § 271(e)(1) or from manufacturing Natco’s ANDA Product outside the United States, (ii) Plaintiffs from asserting patents issued outside the United States against Natco’s activities outside the United States, or (iii) Natco and Plaintiffs from later agreeing in writing to modify the terms. Each party shall bear its own costs, attorney fees and expenses.
Bristol-Myers Squibb Co. v. Lupin Ltd., 20-7810 (D.N.J.)	Sprycel® (dasatinib tablets)	7,491,725 8,680,103	All claims, counterclaims, and defenses asserted by the parties are dismissed without prejudice. Each party shall bear its own costs and fees.
Bristol-Myers Squibb Co. v. Dr. Reddy’s Labs., Ltd., 19-18686 (D.N.J.)	Sprycel® (dasatinib tablets)	7,491,725 8,680,103	All claims, counterclaims, and defenses asserted by the parties are dismissed without prejudice. Each party shall bear its own costs and fees.
Lipocine Inc. v. Clarus Therapeutics, Inc., 19-0622 (D. Del.)	Jatenzo® (testosterone undecanoate capsules) Tlando™ (testosterone undecanoate capsules)	9,034,858 9,205,057 9,480,690 9,757,390 6,569,463 6,923,988	Action, including claims and counterclaims, is dismissed with prejudice, with each side to bear its own costs, expenses, and attorney’s fees.
Pfizer Inc. v. Dr. Reddy’s Labs., Inc., 19-0750 (D. Del.)	Ibrance® (palbociclib capsules)	6,936,612 RE47,739 7,456,168	All claims and affirmative defenses are dismissed without prejudice. Nothing shall prevent DRL from engaging in (i) activities covered by 21 U.S.C. § 271(e)(1) or from manufacturing DRL’s ANDA Product outside the United States, (ii) Plaintiffs from asserting patents issued outside the United States against DRL’s activities outside the United States, or (iii) DRL and Plaintiffs from later agreeing in writing to modify the terms Each party shall bear its own costs, attorney fees and expenses.
Celgene Corp. v. Aurobindo Pharma Ltd., 20-0315, 21-0624 (D.N.J.)	Revlimid® (lenalidomide capsules)	7,465,800 7,855,217 7,968,569 8,530,498 8,648,095 9,101,621 9,101,622 7,977,357 8,193,219 8,431,598	Until their expiration, Aurobindo is enjoined from infringing the patents-in-suit unless specifically 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 Aurobindo from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving Aurobindo’s ANDA or the Aurobindo ANDA product.
AstraZeneca AB v. Apotex Inc., 18-2010 (D. Del.)	Movantik® (naloxegol tablets)	9,012,469	All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
ViiV Healthcare Co. v. Sandoz Inc., 17-1784 (D. Del.)	Tivicay® (dolutegravir tablets)	9,242,986	Unless otherwise specifically authorized pursuant to the parties’ settlement agreement, Sandoz 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.
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 19-0760 (D. Del.)	Ibrance® (palbociclib capsules)	6,936,612 RE47,739 7,456,168	All claims and affirmative defenses are dismissed without prejudice. Nothing shall prevent Zydus from engaging in (i) activities covered by 21 U.S.C. § 271(e)(1) or from manufacturing Zydus’s ANDA Product outside the United States, (ii) Plaintiffs from asserting patents issued outside the United States against Zydus’s activities outside the United States, or (iii) Zydus and Plaintiffs from later agreeing in writing to modify the terms Each party shall bear its own costs, attorney fees and expenses.
Celgene Corp. v. Mylan Pharms. Inc., 20-0003 (N.D.W.V.)	Revlimid® (lenalidomide capsules)	7,189,740 7,465,800 7,968,569 8,404,717 8,530,498 8,648,095 9,056,120 9,101,621 9,101,622 7,977,357 8,193,219 8,431,598	Until their expiration, Mylan is enjoined from infringing the patents-in-suit, unless otherwise specifically 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 Mylan from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit or any other patent listed in FDA’s Orange Book in connection with Revlimid. Nothing restricts FDA from approving Mylan’s ANDA or the Mylan ANDA product.
Boehringer Ingelheim Pharms. Inc. v. Zydus Pharms. (USA) Inc., 18-1763, 19-1295, 19-1501 (D. Del.)	Jardiance® (empagliflozin tablets) Synjardy® (empagliflozin / metformin tablets)	7,579,449 7,713,938 8,551,957 9,949,998 10,258,637	In the absence of a license, the patents-in-suit are infringed by the Zydus ANDA products. Unless specifically authorized pursuant to the settlement agreement, Zydus is enjoined from infringing the patents-in-suit. Nothing prevents Zydus from maintaining a “paragraph IV certification” with respect to the patents-in-suit. Nothing precludes Zydus from filing a “paragraph IV certification” against the patents-in-suit in any future proceedings and litigation with products that are not the Zydus ANDA products. All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Boehringer Ingelheim Pharms. Inc. v. Alkem Labs. Ltd., 18-1738, 19-1493 (D. Del.)	Jardiance® (empagliflozin tablets) Synjardy® (empagliflozin / metformin tablets)	8,551,957 9,949,998 10,258,637	Alkem admits that the patents-in-suit are valid and enforceable, and at least one claim of each of the patents-in-suit is infringed by the Alkem ANDA product. Unless specifically authorized pursuant to the settlement agreement, Alkem is enjoined from infringing the patents-in-suit. All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Merck Sharp & Dohme B.V. v. MSN Labs. Private Ltd., 20-3314 (D.N.J.)	Bridion® (sugammadex for injection)	RE44,733	MSN 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.
Merck Sharp & Dohme B.V. v. Biophore Pharma Inc., 20-3795 (D.N.J.)	Bridion® (sugammadex for injection)	RE44,733	Biophore 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.
Forest Labs., LLC v. Zydus Pharms. (USA) Inc., 17-10330 (D.N.J.)	Fetzima® (levomilnacipran HCl extended-release capsules)	8,481,598 8,865,937 RE43,879	Zydus admits that submission of its ANDA before the expiration of the patents-in-suit was an act of infringement, and further stipulates to the enforceability and validity of the patents-in-suit with respect to this action only. The parties agree that all other claims, defenses, and counterclaims should be dismissed, without prejudice.
Mitsubishi Tanabe Pharma Corp. v. MSN Labs. Private Ltd., 17-5005, 17-5302, 19-15616 (D.N.J.)	Invokana® (canagliflozin tablets) Invokamet® XR (canagliflozin / metofmin extended-release tablets)	7,943,582 8,513,202	The action with respect to the ’202 patent is dismissed with prejudice. The submission of the MSN ANDAs prior to the expiration of the ’582 patent was a technical act of infringement. At least one of the asserted claims of the ’582 patent is valid and enforceable with respect to the MSN ANDA products. MSN is enjoined from infringing the ’582 patent until its expiration, other than as authorized by Plaintiffs. This judgment may not be asserted agaisnt MSN in any cause of action with respect to any products other than the MSN ANDA products. All affirmative defenses, claims, and counterclaims are dismissed with prejudice. Parties shall bear their own costs and fees. Parties waive all right to appeal.
Bayer Pharma AG v. Accord Healthcare Inc., 21-0566 (D. Del.)	Xarelto® (rivaroxaban tablets)	10,828,310	All claims and defenses asserted by Plaintiffs against Accord and all claims and defenses asserted by Accord against Plaintiffs, are dismissed with prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
Boehringer Ingelheim Pharms., Inc. v. Qilu Pharm. Co., Ltd., 21-1732 (D.N.J.)	Gilotrif® (afatinib tablets)	RE43,431 8,426,586 10,004,743	The patents-in-suit are valid and enforceable. Except as specifically authorized by BI, Qilu is enjoined from infringing the patents-in-suit through their expiration. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disburstements, or attorney fees to any party. Nothing prohibits Qilu from maintaining a Paragraph IV Certification to the asserted patents solely for purposes of receiving or maintaining final approval of Qilu’s ANDA product or prohibits FDA from granting final approval to Qilu’s ANDA. All remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
ViiV Healthcare Co. v. Apotex Inc., 17-1634 (D. Del.)	Triumeq® (abacavir / dolutegravir / lamivudine tablets) Tivicay® (dolutegravir tablets)	9,242,986	Except as specifically authorized pursuant to the settlement agreement, Apotex is enjoined from infringing the ’986 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
ViiV Healthcare Co. v. Lupin Ltd., 17-1576 (D. Del.)	Triumeq® (abacavir / dolutegravir / lamivudine tablets)	9,242,986	Except as specifically authorized pursuant to the settlement agreement, Lupin is enjoined from infringing the ’986 patent. All claims and demands are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. Nothing prohibits Lupin from maintaining any “Paragraph IV Certification” with respect to the ’986 patent or any other patent. Nothing shall have preclusive or other res judicata effect on Lupin in any other pending or future action involving a product other than the Lupin ANDA product, and nothing prohibits Lupin from challenging the validity, enforceability or infringement of the ’986 patent or any other patent in any other action or proceeding involving a product other than the Lupin ANDA product. The 30-month stay under is terminated and no longer in effect.
Boehringer Ingelheim Pharms., Inc. v. Sandoz Inc., Ltd., 17-8825 (D.N.J.)	Gilotrif® (afatinib tablets)	RE43,431 8,426,586	The patents-in-suit are valid and enforceable. Except as specifically authorized by BI, Sandoz is enjoined from infringing the patents-in-suit through their expiration. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disburstements, or attorney fees to any party. Nothing prohibits Sandoz from maintaining a Paragraph IV Certification to the asserted patents solely for purposes of receiving or maintaining final approval of Sandoz’s ANDA product or prohibits FDA from granting final approval to Sandoz’s ANDA. All remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
Celgene Corp. v. Aurobindo Pharma Ltd., 19-0143, 19-5799, 20-2606 (D.N.J.)	Pomalyst® (pomalidomide capsules)	8,198,262 8,673,939 8,735,428 8,828,427 9,993,467 10,093,647 10,093,648 10,093,649 10,555,939	Until their expiration, Aurobindo is enjoined from infringing the patents-in-suit unless specifically 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 shall prohibit Aurobindo from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving Aurobindo’s ANDA.
Pfizer Inc. v. Aizant Drug Research Solutions Pvt. Ltd., 19-0743 (D. Del.)	Ibrance® (palbociclib capsules)	6,936,612 RE47,739 7,456,168	All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Nothing shall prevent Aizant from engaging in (i) activities covered by 21 U.S.C. § 271(e)(1) or from manufacturing Aizant’s ANDA Product outside the United States, (ii) Plaintiffs from asserting patents issued outside the United States against Aizant’s activities outside the United States, or (iii) Aizant and Plaintiffs from later agreeing in writing to modify the terms Each party shall bear its own costs, attorney fees and expenses.
Eli Lilly and Co. v. Radius Health, Inc., 21-1003 (D. Del.)	Tymlos® (abaloparatide for injection) Forteo® (teriparatide for injection)	7,517,334	Plaintiff dismisses this action without prejudice.
Millennium Pharms., Inc. v. Sun Pharm. Indus. Ltd., 20-0289 (D. Del.)	Ninlaro® (ixazomib citrate capsules)	7,442,830 8,859,504 9,175,017	All claims and counterclaims, defenses, motions, and petitions are dismissed without prejudice. Unless otherwise agreed to by the parties, Sun is enjoined infringing the patents-in-suit. Each party shall bear its own costs and attorneys’ fees. The parties waive any right to appeal.
Bausch Health US, LLC v. Lupin Ltd, 18-13700, 18-17501, 20-2744 (D.N.J.)	Jublia® (efinaconazole topical solution)	7,214,506 8,039,494 8,486,978 9,302,009 9,566,272 9,662,394 9,861,698 9,877,955 10,105,444 10,512,640 10,342,875 10,478,601	Subject to the provisions of the Settlement Agreement, the case is dismissed with respect to Lupin, without prejudice. Lupin shall be entitled to contest the infringement, validity and/or enforceability of the patents-in-suit in any future litigation over the patents-in-suit pertaining to any product that is not the Lupin ANDA product. Each party will bear its own attorneys’ fees and costs. Lupin is allowed to maintain its Paragraph IV certifications to the patents-in-suit. Each Party acknowledges and agrees that the 30-month stay with respect to the approval of the Lupin ANDA is terminated. Lupin is entitled to pursue and obtain FDA approval for the Lupin ANDA and the Lupin Product prior to expiration of the patents-in-suit.
Celgene Corp. v. Torrent Pharms. Ltd., 21-12927 (D.N.J.)	Revlimid® (lenalidomide capsules)	7,189,740 7,465,800 7,855,217 7,968,569 8,404,717 8,530,498 8,648,095 9,056,120 9,101,621 9,101,622	Until their expiration, Torrent is enjoined from infringing the patents-in-suit, unless otherwise specifically 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 Torrent from maintaining any Paragraph IV Certification with respect to the patents-in-suit. Nothing restricts FDA from approving Torrent’s ANDA.
Hikma Pharms. USA Inc. v. Aurobindo Pharma Ltd., 21-0228 (D. Del.)	Mitigare® (colchicine capsules)	8,927,607 9,399,036 9,555,029 9,675,613 9,789,108	The complaint is dismissed, without prejudice. Each party shall bear its own costs and attorneys’ fees.
Merck Sharp & Dohme B.V. v. Fisiopharma S.R.L., 20-2964 (D.N.J.)	Bridion® (sugammadex for injection)	RE44,733	Unless specifically authorized pursuant to an agreement between Fisiopharma and Merck, Fisiopharma 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.
Astellas US LLC v. Accord Healthcare, Inc., 19-1199 (D. Del.)	Lexiscan® (regadenoson for injection)	8,106,183 RE47,301 8,524,883	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.
Genentech, Inc. v. Teva Pharms. USA, Inc., 19-0136 (D. Del.)	Esbriet® (pirfenidone tablets)	7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947	The complaint is dismissed, without prejudice. Each party shall bear its own costs and attorneys’ fees.
Celgene Corp. v. Hetero Labs Ltd., 17-3387 (D.N.J.)	Pomalyst® (pomalidomide capsules)	8,198,262 8,673,939 8,735,428 8,828,427 9,993,467 10,093,647 10,093,648 10,093,649 10,555,939	Until their expiration, Hetero is enjoined from infringing the patents-in-suit unless specifically 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 shall prohibit Hetero from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving Hetero’s ANDA.
Genentech, Inc. v. Shilpa Medicare Ltd., 19-0130, 20-0624 (D. Del.)	Esbriet® (pirfenidone tablets)	7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,318,780 8,420,674 8,592,462 8,609,701 8,383,150 8,778,947	The complaint is dismissed, without prejudice. Each party shall bear its own costs and attorneys’ fees.
Allergan Sales, LLC v. Torrent Pharms. Ltd., 17-10273, 19-21709 (D.N.J.)	Fetzima® (levomilnacipran HCl extended-release capsules)	8,481,598 8,865,937 RE43,879	Torrent admits that submission of its ANDA before the expiration of the patents-in-suit was an act of infringement, and further stipulates to the enforceability and validity of the patents-in-suit. Absent a license or authorization by plaintiffs, Torrent is enjoined from infringing the patents-in-suit during the life of he patents-in-suit untill all of the claims are found invalid or unenforceable by a court from which no appeal has been or can be taken. The parties waive any right to appeal. The parties agree that all other claims, defenses, and counterclaims should be dismissed, without prejudice.
UCB, Inc. v. Annora Pharma Private Ltd., 20-0987 (D. Del.)	Briviact® (brivaracetam tablets)	6,911,461	All claims, counterclaims, and affirmative defenses between plaintiffs and Micro Labs are dismissed, with each party to bear its own costs, disbursements, and attorney fees.
Genentech, Inc. v. Macleods Pharms. Ltd., 19-0154 (D. Del.)	Esbriet® (pirfenidone capsules)	7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947 7,696,236 7,767,225 7,988,994 8,753,679	The complaint is dismissed, without prejudice. Each party shall bear its own costs and attorneys’ fees.
Sanofi-Aventis U.S. LLC v. Mylan Labs. Ltd., 20-0761 (D. Del.)	Jevtana® Kit (cabazitaxel injection)	10,583,110	All claims and counterclaims are dismissed with prejudice. Nothing prohibits FDA from granting final approval to Mylan’s ANDA. The parties are to bear their own costs.
Pfizer Inc. v. Teva Pharms. USA, Inc., 18-1940 (D. Del.)	Xeljanz XR® (tofacitinib extended-release tablets)	9,937,181	All claims and counterclaims are dismissed without prejudice. Any protective orders entered by the Court shall remain in full force and effect. The parties waive any right of appeal. Each party shall bear its own costs and fees.
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. Aurobindo Pharma USA Inc., 19-2197 (D. Del.)	Desyrel® (trazodone HCl tablets)	8,133,893	All claims, counterclaims, and affirmative defenses are dismissed with prejudice, and without costs, disbursements, or attorneys’ fees to any party. The parties waive appeal.
EPI Health, LLC v. Padagis Israel Pharms. Ltd., 21-0498 (D. Del.)	Rhofade® (oxymetazoline HCl cream)	7,812,049 8,420,688 8,815,929 8,883,838 9,974,773 10,335,391 10,751,325	All claims and counterclaims, defenses, motions, and petitions are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. Parties waive any right to appeal.
Eli Lilly and Co. v. Sun Pharm. Indus. Ltd., 21-1092 (D. Del.)	Forteo® (teriparatide for injection)	7,517,334	Action dismissed without prejudice.
Allergan Sales, LLC v. MSN Labs. Private Ltd., 17-10140 (D.N.J.)	Fetzima® (levomilnacipran HCl extended-release capsules)	8,481,598 8,865,937 RE43,879	MSN admits that submission of its ANDA before the expiration of the patents-in-suit was an act of infringement of the patents-in-suit. MSN stipulates to the enforceability and validity of the patents-in-suit. All other claims, defenses, and counterclaims are dismissed without prejudice. Absent a license, MSN is enjoined from infringing the patents-in-suit unless all of the claims are found invalid or unenforceable. Parties waive right to appeal.
Allergan Sales, LLC v. Aurobindo Pharma USA, Inc., 17-11679 (D.N.J.)	Fetzima® (levomilnacipran HCl extended-release capsules)	8,481,598 8,865,937 RE43,879	Aurobindo admits that submission of its ANDA before the expiration of the patents-in-suit was an act of infringement of the patents-in-suit. Aurobindo stipulates to the enforceability and validity of the patents-in-suit. All other claims, defenses, and counterclaims are dismissed without prejudice and without costs, distribursements, or attorneys’ fees to any party. Absent a license, Aurobindo is enjoined from infringing the patents-in-suit unless all of the claims are found invalid or unenforceable. Parties waive right to appeal.
Merck Sharp & Dohme Corp. v. Ajanta Pharma Ltd., 20-0815, 20-1496 (D. Del.)	Januvia® (sitagliptin phosphate tablets)	7,326,708	Unless otherwise authorized under the settlement agreement, Ajanta 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.
Merck Sharp & Dohme Corp. v. Sandoz Inc., 19-0312 (D. Del.)	Januvia® (sitagliptin phosphate tablets) Janumet® (metformin / sitagliptin tablets)	7,326,708	Unless otherwise authorized under the settlement agreement, Sandoz is enjoined from infringing the ’708 patent. Nothing shall prevent FDA from granting final approval to the Sandoz ANDAs. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Merck Sharp & Dohme Corp. v. Zydus Pharms. (USA) Inc., 19-0314 (D. Del.)	Januvia® (sitagliptin tablets) Janumet® (metformin / sitagliptin tablets) Janumet® XR (metformin / sitagliptin extended-release tablets)	7,326,708	All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorney’s fees.
Merck Sharp & Dohme Corp. v. Apotex Inc., 19-0313, 20-0749 (D. Del.)	Januvia® (sitagliptin phosphate tablets)	7,326,708	Unless otherwise authorized under the settlement agreement, Apotex 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.
Bausch Health Ireland Ltd. v. Lupin Ltd., 21-11258 (D.N.J.)	Plenvu® (PEG 3350 / sodium ascorbate / sodium sulfate / ascorbic acid / sodium chloride / potassium chloride oral solution)	10,918,723	All claims are dismissed without prejudice and without costs, disbursements, or attorney fees. Plaintiffs acknowledge that Defendnats are entitled to maintain their Paragraph IV certification to the ’723 patent.
AstraZeneca AB v. Aurobindo Pharma USA Inc., 19-2113 (D. Del.)	Movantik® (naloxegol tablets)	9,012,469	All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Merz Pharms., LLC v. MSN Pharms. Inc., 21-1032 (D. Del.)	Cuvposa® (glycopyrrolate oral solution)	7,638,552 7,816,396	All claims and counterclaims are dismissed without prejudice. The parties will submit their settlement and license agreement to FTC and DOJ as soon as practicable. Each Party will bear its own costs and attorneys’ fees
Keryx Biopharmaceuticals, Inc. v. Mylan Pharms. Inc., 19-1445 (D. Del.)	Auryxia® (ferric citrate tablets)	5,753,706 7,767,851 8,093,423 8,299,298 8,338,642 8,609,896 8,754,257 8,754,258 8,846,976 8,901,349 9,050,316 9,328,133 9,387,191 9,757,416	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.
Celgene Corp. v. Hetero Labs Ltd., 20-14389 (D.N.J.)	Revlimid® (lenalidomide capsules)	7,189,740 7,465,800 7,968,569 7,977,357 8,193,219 8,404,717 8,530,498 8,648,095 9,056,120 9,101,621 9,101,622	Until expiration of the patents-in-suit, Hetero is enjoined from infringing the patents-in-suit, unless otherwise authorized by Celgene. All claims, counterclaims, affirmative defenses, and demands in this action are dismissed without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Hetero from maintaining a “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving Heter’s ANDA.
Supernus Pharms., Inc. v. Zydus Pharms. (USA) Inc., 21-7795 (S.D.N.Y.)	Trokendi XR® (topiramate extended-release capsules)	8,298,576 8,298,580 8,663,683 8,877,248 8,889,191 8,992,989 9,549,940 9,555,004 9,622,983 10,314,790	Action dismissed without prejudice.
Merck Sharp & Dohme Corp. v. Aurobindo Pharma USA, Inc., 20-0949, 20-1099 (D. Del.)	Januvia® (sitagliptin phosphate tablets) Janumet® (metformin / sitagliptin tablets)	7,326,708	Unless otherwise authorized under the settlement agreement, Aurobindo 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.
Merck Sharp & Dohme Corp. v. Sun Pharm. Indus. Ltd., 19-0319 (D. Del.)	Januvia® (sitagliptin phosphate tablets) Janumet® (metformin / sitagliptin tablets)	7,326,708	Unless otherwise authorized under the settlement agreement, Sun is enjoined from infringing the ’708 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed without costs, disbursements or attorneys’ fees to any party.