ANDA Litigation Settlements Winter 2021 | Hatch-Waxman

Reported settlements in federal district court cases

Fourth 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
Astellas Pharma Inc. v. Sandoz Inc., 16-0952 (D. Del.)	Myrbetriq® (mirabegron extended-release tablets)	7,342,117 7,982,049 8,835,474 RE44,872	All claims and counterclaims related to the patents-in-suit are dismissed 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.
Bausch Health US, LLC v. Aleor Dermaceuticals Ltd., 20-2735 (D.N.J.)	Jublia® (efinaconazole topical solution)	8,039,494 8,486,978 9,302,009 9,566,272 9,662,394 9,861,698 9,877,955 10,105,444 10,342,875 10,478,601 10,512,640	In the event that the claims of the patents-in-suit are not held invalid or unenforceable, absent a license, the patents-in-suit would be infringed by Aleor’s ANDA product. Aleor is enjoined until expiration of the patents-in-suit from infringing the patents-in-suit. Aleor may contest the infringement, validity, and/or enforceability of the patents-in-suit in any future litigation related to a product that is not the Aleor ANDA product. Each party will bear its own attorneys’ fees and costs. Defendant is entitled to maintain its PIV certification to the patents-in-suit. The parties acknowledge that the 30-month stay with respect to the approval of the Aleor ANDA is terminated.
Celgene Corp. v. Amneal Pharms. LLC, 18-11358 (D.N.J.)	Otezla® (apremilast tablets)	6,962,940 7,427,638 7,659,302 7,893,101 8,455,536 9,018,243 9,724,330 10,092,541	Amneal admits that the patents-in-suit are valid and enforceable. Amneal admits that the patents-in-suit would be infringed by its ANDA product. Until their expiration, Amneal is enjoined from infringing the patents-in-suit, except as authorized by Amgen in writing. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
UCB, Inc. v. Zydus Worldwide DMCC, 16-1023 (D. Del.)	Neupro® (rotigotine transdermal system)	8,246,979 8,246,980 8,617,591 6,884,434	N/A
Pharmacyclics LLC v. Zydus Worldwide DMCC, 20-0560 (D. Del.)	Imbruvica® (ibrutinib tablets)	7,514,444 8,008,309 8,476,284 8,497,277 8,697,711 8,735,403 8,754,090 8,754,091 8,952,015 8,957,079 9,181,257 9,296,753 9,725,455 10,010,507 10,106,548 10,125,140 10,213,386 10,478,439	No party admits liability. Each party shall bear its own costs, attorney fees, and expenses. Plaintiffs’ claims against Defendants are dismissed without prejudice. Defendants’ claims against Plaintiffs are dismissed without prejudice.
Eisai Co., Ltd. v. MSN Pharms. Inc., 20-0791 (D. Del.)	Banzel® (rufinamide)	6,740,669	The patent is enforceabl and valid. MSN has techincally infringed the patent by filing its ANDA. Except as permitted by the settlement agreement, MSN is enjoined from infringing the patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or, except if set forth in the settlement agreement, attorneys’ fees to any party. The parties waive any right to appeal.
Boehringer Ingelheim Pharms., Inc. v. MSN Labs. Private Ltd., 17-8399 (D.N.J.)	Gilotrif® (afatinib dimaleate tablets)	RE 43,431 8,426,586	Except as authorized by Plaintiff, MSN is enjoined from infringing the patents-in-suit with respect to MSN’s ANDA products until the expiration of the patents-in-suit. Nothing prohibits MSN from maintaining a PIV certification to the patents-in-suit or prohibits FDA from granting final approval to MSN’s ANDA. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
Cubist Pharms. LLC v. Cipla USA, Inc., 19-12920 (D.N.J.)	Cubicin RF® (daptomycin for injection)	9,138,456	N/A
Novartis Pharms. Corp. v. Accord Healthcare, Inc., 18-1043 (D. Del.)	Gilenya® (fingolimod)	9,187,405	Judgment is entered that Dr. Reddy’s ANDA product infringes all claims of the ’405 patent. By virtue of the license granted by Novartis to Dr. Reddy, judgment is entered such that there no longer exists a cause of action for infringement of the ’405 patent by Dr. Reddy’s ANDA product. Final approval of Dr. Reddy’s ANDA may be granted by FDA. All other claims and counterclaims by Dr. Reddy’s or against Dr. Reddy’s are dismissed with prejudice. Dr. Reddy’s is enjoined from infringing the ’405 patent with respect to its ANDA product prior to the Generic Entry Date as defined in the Settlement Agreement, except as otherwise permitted by the Settlement Agreement. Each party shall bear its own costs and attorney fees. The parties waive any right to appeal. Dr. Reddy’s waives any right it may have to recover against the preliminary injunction bond, and any obligation Novartis may have under that bond to Dr. Reddy’s is terminated.
Novartis Pharms. Corp. v. Accord Healthcare, Inc., 18-1043 (D. Del.)	Gilenya® (fingolimod)	9,187,405	Judgment is entered that Sun’s ANDA product infringes all claims of the ’405 patent. By virtue of the license granted by Novartis to Sun, judgment is entered such that there no longer exists a cause of action for infringement of the ’405 patent by Sun’s ANDA product. Final approval of Sun’s ANDA may be granted by FDA. All other claims and counterclaims by Sun or against Sun are dismissed with prejudice. Sun is enjoined from infringing the ’405 patent with respect to its ANDA product prior to the Generic Entry Date as defined in the Settlement Agreement, except as otherwise permitted by the Settlement Agreement. Each party shall bear its own costs and attorney fees. The parties waive any right to appeal.
Novartis Pharms. Corp. v. Accord Healthcare, Inc., 18-1043 (D. Del.)	Gilenya® (fingolimod)	9,187,405	Judgment is entered that Mylan’s ANDA product infringes all claims of the ’405 patent. Final approval of Mylan’s ANDA may be granted by FDA. All other claims and counterclaims by Mylan or against Mylan are dismissed with prejudice. Mylan is enjoined from infringing the ’405 patent with respect to its ANDA product prior to the Generic Entry Date as defined in the Settlement Agreement, except as otherwise permitted by the Settlement Agreement. Each party shall bear its own costs and attorney fees. The parties waive any right to appeal.
AstraZeneca AB v. Macleods Pharms. Ltd., 20-1180 (D. Del.)	Brilinta® (ticagrelor tablets)	10,300,065	Unless authorized pursuant to the settlement agreement, Macleods is enjoined from infringing the ’065 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Eisai R&D Management Co., Ltd. v. Shilpa Medicare Ltd., 19-19998 (D.N.J.)	Lenvima® (lenvatinib mesylate capsules)	10,259,791	All claims, counterclaims, and defenses as between Plaintiffs and Shilpa concerning the ’791 patent are dismissed without prejudice, and each party shall bear its own costs and attorney fees with respect to the ’791 patent. This stipulation shall have no effect on the claims and defenses with respect to U.S. Patent No. 10,407,393 or U.S. Patent No. 9,006,256, which remain in suit.
Merz Pharms., LLC v. Granules Pharms., Inc., 20-0848 (D. Del.)	Cuvposa® (glycopyrrolate oral solution)	7,638,552 7,816,396	All claims and counterclaims between the parties are dismissed without prejudice. Each party will bear its own costs and attorneys’ fees.
Bayer Intellectual Property GmbH v. Dr. Reddy’s Labs., Inc., 20-10378 (D.N.J.)	Xarelto® (rivaroxaban tablets)	9,539,218	Plaintiffs’ action against DRL and DRL’s action against Plaintiffs, including all claims and defenses asserted by Plaintiffs against DRL and all claims and defenses asserted by DRL against Plaintiffs, are dismissed with prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
Boehringer Ingelheim Pharms. Inc. v. Annora Pharma Private Ltd., 18-1786, 19-1594, 20-0277 (D. Del.)	Jardiance® (empagliflozin tablets)	8,551,957 9,949,998 10,258,637	The patents-in-suit are valid, enforceable, and infringed by Annora and Hetero’s ANDA products. Unless authorized by the parties, Annora and Hetero are enjoined from infringing the patents-in-suit. The complaints and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Bausch Health US, LLC v. KVK-Tech, Inc., 20-2742 (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 10,478,601 10,512,640 10,342,875	Subject to the parties’ settlement agreement, this action is dismissed with respect solely to KVK, without prejudice. KVK 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 KVK ANDA product. Each party will bear its own attorneys’ fees and costs. KVK is entitled to maintain its PIV certifications to the patents-in-suit. The 30-month stay with respect to the approval of the KVK ANDA is terminated. KVK may pursue and obtain FDA approval for the KVK ANDA product prior to the expiration of the patents-in-suit.
Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., 19-0318 (D. Del.)	Janumet® XR (sitagliptin phosphate / metformin HCl extended-release tablets) Januvia® (sitagliptin phosphate) Janumet® (sitagliptin phosphate / metformin HCl) Juvisync® (simvastatin/ sitagliptin phosphate)	7,326,708	Unless authorized by the settlement agreement, Teva is enjoined from infringing the patents-in-suit. Nothing prohibits Teva from maintinaing PIV certifications with respect to the Orange Book-listed patents solely for the purposes of receiving FDA final approval of the Teva ANDA products. All claims, counterclaims, affirmative defenses and demands are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Celgene Corp. v. Breckenridge Pharm., Inc., 18-14715, 19-5804, 20-2597 (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 expiration of the Patents-in-Suit, Breckenridge is enjoined from infringing the patents-in-suit, unless authorized by Celgene, and is further enjoined from assisting or cooperating with any third parties in connection with any infringement of the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands in this action that relate to Breckenridge are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing herein prohibits Breckenridge from maintaining any PIV certifications with respect to the patents-in-suit. Nothing restricts the FDA from approving Breckenridge’s ANDA.
Novartis Pharms. Corp. v. Accord Healthcare, Inc., 18-1043 (D. Del.)	Gilenya® (fingolimod)	9,187,405	Judgment is entered that Torrent’s ANDA product infringes all claims of the ’405 patent. Final approval of Torrent’s ANDA may be granted by FDA. All other claims and counterclaims by Torrent or against Torrent are dismissed with prejudice. Torrent is enjoined from infringing the ’405 patent with respect to its ANDA product prior to the Generic Entry Date as defined in the Settlement Agreement, except as otherwise permitted by the Settlement Agreement. Each party shall bear its own costs and attorney fees. The parties waive any right to appeal.
Astellas US LLC v. USV Private Ltd., 20-0793 (D. Del.)	Lexiscan® (regadenoson for injection)	8,106,183 RE47,301 8,524,883	All claims and counterclaims, defenses, motions, and petitions asserted in this action are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. The parties waive any right to appeal.
Sucampo Gmbh v. Zydus Pharms. (USA) Inc., 20-0936 (D.N.J.)	Amitiza® (lubiprostone capsules)	7,795,312 8,026,393 8,338,639 8,779,187 8,748,481	Zydus admits that the submission of its ANDA was a technical act of infringement of the patents-in-suit. This admission is further without prejudice to any claim, defense or counterclaim in any future action between the parties. Zydus is enjoined from infringing the patents-in-suit until January 1, 2023, or at such earlier date as may be permitted by the resolution to which the parties have agreed. The parties waive any right to appeal. The consent judgment and order is without prejudice to, and shall have no preclusive effect as to, any claim, defense, or counterclaim in any future action between the parties regarding a generic lubiprostone product other than the Zydus ANDA product.
Medicure Int’l, Inc. v. Nexus Pharms., Inc., 19-7979 (N.D. Ill.)	Aggrastat® (tirofiban HCl for injection)	6,770,660	Claims 1-6 of the patent-in-suit are valid and enforceable, and Defendant’s affirmative defenses, claims, and counterclaims are dismissed with prejudice. The filing of Defendant’s ANDA infringed the patent-in-suit. Defendant’s ANDA product would infringe the patent-in-suit. Judgment of infringement by Defendant is entered in favor of Plaintiff. Except as permitted by the Settlement or License Agreement, Defendant is enjoined from challenging the validity or enforceability of the patent-in-suit or asserting that the ANDA product does not infringe. Any Protective Order shall remain in full force and effect notwithstanding the conclusion of this action. The parties waive all right to appeal. Each party is to bear its own costs, expenses, and attorneys’ fees. Nothing shall prohibit Nexus from maintaining or filing Paragraph IV certifications in Nexus’s and nothing shall prohibit the FDA from reviewing or approving Nexus’s ANDA.
H. Lundbeck A/S v. Torrent Pharms. Ltd., 18-0149, -0672 (D. Del.)	Trintellix® (vortioxetine hydrobromide tablets)	7,144,884 8,722,684 8,969,355 9,227,946 9,861,630 9,125,910 9,278,096	Unless authorized pursuant to the Settlement Agreement, Torrent is enjoined from infringing the patents-in-suit. All claims, countercaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees.
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 20-0300, -301 (D. Del.)	Xeljanz XR® (tofacitinib extended-release tablets)	6,965,027 7,301,023 RE41,783	All claims and counterclaims between the parties 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.
Spectrum Pharms., Inc. v. Fresenius Kabi USA, LLC, 18-1533 (D. Del.)	Beleodaq® (belinostat for injection)	6,888,027 8,835,501	Plaintiffs’ claims and Defendants’ counterclaims are dismissed with prejudice. Each party to bear their own costs.
Osmotica Pharm. US LLC v. Adamas Pharms., Inc., 18-0278 (D. Del.)	Osmolex ER® (amantadine HCl tablets)	8,389,578 8,741,343 8,796,337 8,889,740 8,895,614 8,895,615 8,895,616 8,895,617 8,895,618 8,987,333 9,072,697	Settlement agreement will close in early 2021. All claims and counterclaims to be dismissed. Adamas will acquire the global rights to Osmolex ER® for $7.5 million.
Genzyme Corp. v. Dr. Reddy’s Labs., Inc., 19-2045 (D. Del.)	Cerdelga® (eliglustat capsules)	6,916,802 7,253,185 7,615,573	Claims and counterclaims are dismissed without prejudice. Plaintiffs and DRL shall bear their own costs. Nothing shall prevent FDA from granting final approval on DRL’s ANDA.
ViiV Healthcare Co. v. Laurus Labs Ltd., 17-1576, -1784 (D. Del.)	Tivicay® (dolutegravir tablets) Triumeq® (abacavir / dolutegravir / lamivudine tablets)	9242986	Except as specifically authorized pursuant to the settlement agreement, Laurus 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.
Merck Sharp & Dohme Corp. v. Unichem Labs. Ltd., 20-1227 (D. Del.)	Januvia® (sitagliptin phosphate tablets)	7,326,708	Unless otherwise authorized by t he settlement agreement, Unichem 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.
Celgene Corp. v. Cipla Ltd., 17-6163, 18-8964, 19-14731, 20-7759 (D.N.J.)	Revlimid® (lenalidomide capsules)	7,189,740 7,465,800 7,968,569 7,977,357 8,193,219 8,404,717 8,431,598 8,530,498 8,648,095 9,056,120 9,101,621 9,101,622	Until expiration of the patents-in-suit, Cipla is enjoined from infringing the patents-in-suit unless and to the extent otherwise specifically authorized by Celgene. All claims, counterclaims, affirmative defenses, and demands in these actions are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. Nothing prohibits or is intended to prohibit Cipla from filing and maintaining any Paragraph IV Certification with respect to the patents-in-suit or any other patent listed in the Orange Book in connection with Revlimid®. Nothing prohibits Cipla from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts the FDA from approving the Cipla ANDAs or the Cipla ANDA Products.
Pharmacyclics LLC v. Sandoz Inc., 20-0403 (D. Del.)	Imbruvica® (ibrutinib tablets)	10,478,439	Claims and counterclaims are dismissed without prejudice. Each party to bear its own costs, attorney fees, and expenses.
Vifor Fresenius Medical Care Renal Pharma Ltd. v. Lupin Atlantis Holdings SA, 20-0911 (D. Del.)	Velphoro® (sucroferric oxyhydroxide chewable tablets)	10,682,376 10,695,367	All claims, counterclaims, and affirmative defenses are dismissed without prejudice and, except as specifically provided by agreement, without costs, disbursements, or attorneys’ fees to any party.
Adverio Pharma GmbH v. MSN Labs. Private Ltd., 20-1617 (D. Del.)	Adempas® (riociguat tablets)	10,662,188	All claims, counterclaims, and defenses asserted are dismissed without prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
Merck Sharp & Dohme Corp. v. Aurobindo Pharma USA Inc., 20-10444 (D.N.J.)	Noxafil® (posaconazole for injection)	9,023,790 9,358,297	Aurobindo 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.
Bausch Health US, LLC v. Aurobindo Pharma USA Inc., 20-2738 (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 10,342,875 10478,601 10512,640	In the event that the claims of the patents-in-suit are not held invalid or unenforceale, absent a license from Plaintiffs, the patents-in-suit would be infringed by the ANDA product. Aurobindo is enjoined from infringing the patents-in-suit. Aurobindo shall be entitled to contest the infringement, invalidity, and/or enforceability of the patents-in-suit in any future litigation concerning the patents-in-suit pertaining to any product that is not the ANDA product. Each party shall bear its own attorneys’ fees and costs. Aurobindo is entitled to maintain its PIV certifications against the patents-in-suit. The 30-month stay is terminated.
Bausch Health Companies Inc. v. Mylan Pharms., Inc. 15-8180, 16-0035, 17-6714 (D.N.J.)	Relistor® (methylnaltrexone bromide for injection)	8,247,425 8,420,663 8,552,025 8,822,490 9,669,096	All claims, defenses, and counterclaims between the Parties in this action are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses. The dismissal order shall not act as adjudication on the merits.
Bial – Portela & CA S.A. v. Lupin Ltd., 18-0312, 20-0782 (D. Del.)	Aptiom® (esclicarbazepine acetate tablets)	8,372,431 9,206,135 9,566,244 9,643,929 9,750,747 9,763,954 10,675,287	All claims and defenses are dismissed without prejudice pursuant to the terms of the settlement agreement between Plaintiffs and Lupin. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Celgene Corp. v. Shilpa Medicare Ltd., 18-11157 (D.N.J.)	Otezla® (apremilast tablets)	7,427,638 7,893,101 9,872,854	Shilpa admits that the patents-in-suit are valid and enforceable. Shilpa admits that the patents-in-suit would be infringed by its ANDA product. Until expiration of the patents-in-suit, Shilpa is enjoined from infringing the patents-in-suit, except as authorized by Amgen in writing. All claims, affirmative defenses, counterclaims, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
H. Lundbeck A/S v. Alkem Labs. Ltd., 18-0088, 18-0089 (D. Del.)	Trintellix® (vortioxetine hydrobromide tablets)	8,722,684 8,969,355 9,125,908 9,125,909 9,125,910 9,227,946 9,278,096 9,861,630	Unless otherwise specifically by the settlement agreement, Alkem 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.