ANDA Litigation Settlements

Reported settlements in federal district court cases

First Quarter

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

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
Forest Labs., LLC v. MSN Labs. Private Ltd., 17-10140 (D.N.J.) Fetzima® (levomilnacipran HCl extended-release capsules) 8,865,937 All claims, counterclaims, and defenses relating to the ’937 patent are dismissed without prejudice.
Parties shall bear their own costs and attorney fees.
Novartis Pharms. Corp. v. Accord Healthcare, Inc., 18-1043 (D. Del.) Gilenya® (fingolimod) 9,187,405 Aurobindo’s ANDA product infringes all claims of the ’405 patent asserted against Aurobindo. 
The final judgment and order of injunction entered constitutes a consent decree such that final approval of Aurobindo's ANDA product may be granted. All other claims and counterclaims by Aurobindo or against Aurobindo are dismissed with prejudice.  
Aurobindo is enjoined from infringing the patent-in-suit prior to the Generic Entry Date set forth in the parties’ settlement agreement.
Each party shall each bear its own costs and attorney fees.
The parties waive any right to appeal.
Almirall, LLC v. Perrigo UK Finco Ltd. Partnership, 20-0975 (D. Del.) Aczone® (dapsone gel) 9,517,219 All claims and counterclaims are dismissed without prejudice.
Each party shall bear its own costs, attorneys’ fees, and expenses. Perrigo will not infringe the patent-in-suit pursuant except as provided for in the parties’ settlement agreement.
The stipulation and order shall not act as an adjudication on the merits.
Actelion Pharms. Ltd. v. Laurus Labs Ltd., 20-13967 (D.N.J.) Opsumit® (macitentan tablets) 7,094,781 Laurus admits that the claims of the ’781 patent are valid and enforceable, and that the claims would be infringed by Laurus’s ANDA product.
Unless otherwise specifically authorized by Actelion, Laurus is enjoined from infringing the ’781 patent. All claims, counterclaims, affirmative defenses and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Nothing shall prohibit Laurus from maintaining or filing PIV certifications in its ANDA and nothing shall prohibit the FDA from reviewing or approving Laurus’s ANDA.
The 30-month stay with respect to the approval of Laurus’s ANDA is terminated.
Sanofi-Aventis U.S. LLC v. Hong Kong King-Friend Industrial Co. Ltd., 20-1547 (D. Del.) Jevtana® Kit (cabazitaxel for injection) 10,583,110 10,716,777 Each of Plaintiffs’ claims against HKF is dismissed with prejudice.
The parties shall bear their own costs.
Astellas US LLC v. Meitheal Pharms., Inc., 20-1182 (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 waive any right to appeal.
Celgene Corp. v. Teva Pharms. USA, Inc., 18-11215 (D.N.J.) Otezla® (apremilast tablets) 6,962,940 7,208,516 7,427,638 7,659,302 8,455,536 8,802,717 9,724,330 9,872,854 10,092,541 Teva admits that the patents-in-suit are valid and enforceable with respect to its ANDA product.
Teva is enjoined from infringing the patents-in-suit until their expiration, except as authorized by Amgen.
Nothing shall prevent the FDA from granting final approval to Teva’s ANDA.
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Par Pharm., Inc. v. Aurobindo Pharma U.S.A., Inc., 20-18334 (D.N.J.) Vasostrict® (vasopressin for injection) 10,844,435 All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Merck Sharp & Dohme Corp. v. Lupin Ltd., 20-0776 (D. Del.) Januvia® (sitagliptin phosphate tablets) Janumet XR® (metformin HCl / sitagliptin phosphate extended-release tablets) Janumet® (sitagliptin phosphate / metformin HCl) 7,326,708 Unless otherwise authorized per the settlement agreements, Lupin is enjoined from infringing ’708 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Adamas Pharma, LLC v. Zydus Worlwide DMCC, 20-10463 (D.N.J.) Gocovri® (amantadine HCl extended-release capsules) 8,389,578 8,796,337 8,889,740 8,895,614 8,895,615 8,895,616 8,895,617 8,895,618 8,741,343 9,867,791 9,867,792 9,867,793 9,877,933 10,154,971 10,646,456 All claims are dismissed without prejudice. Each party to bear its own costs, expenses, and attorneys’ fees.
Amgen Inc. v. Centaur Pharms. Private Ltd., 20-0123 (D. Del.) Corlanor® (ivabradine tablets) 7,361,649 7,361,650 7,867,996 7,879,842 Centaur admits that the patents-in-suit are valid and enforceable.
Centaur admits that the patents-in-suit would be infringed by the Centaur ANDA product.
Centaur is enjoined from infringing the patents-in-suit until their expiration, 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.
Actelion Pharms. Ltd. v. Vgyaan Pharms. LLC, 20-3859 (D.N.J.) Uptravi® (selexipag tablets) 8,791,122 9,284,280 All claims, counterclaims, and defenses between Actelion and Vgyaan are dismissed without prejudice, and each party shall bear its own costs and attorney fees.
Actelion Pharms. Ltd. v. MSN Pharms. Inc., 20-3859 (D.N.J.) Uptravi® (selexipag tablets) 8,791,122 9,284,280 All claims, counterclaims, and defenses between Actelion and MSN are dismissed without prejudice, and each party shall bear its own costs and attorney fees.
Actelion Pharms. Ltd. v. Zydus Worldwide DMCC, 20-3859 (D.N.J.) Uptravi® (selexipag tablets) 7,205,302 8,791,122 9,284,280 All claims, counterclaims, and defenses as between Actelion and Zydus concerning the ’122 and ’280 patents are dismissed without prejudice, and each party shall bear its own costs and attorney fees.
This stipulation shall have no effect on the claims and defenses with respect to the ’302 patent, which remains in suit.
Sanofi-Aventis U.S. LLC v. Actavis LLC, 20-0804 (D. Del.) Jevtana® Kit (cabazitaxel injection) 10,583,110 Each of plaintiffs’ claims against Actavis are dismissed with prejudice.
Each of Actavis’s counterclaims is dismissed with prejudice. Nothing prohibits FDA from granting final approval to Actavis’s NDA. Parties to bear their own costs.
Merck Sharp & Dohme Corp. v. Anchen Pharms., Inc., 19-0311 (D. Del.) Januvia® (sitagliptin phosphate tablets) Janumet XR® (metformin HCl / sitagliptin phosphate extended-release tablets) Janumet® (sitagliptin phosphate / metformin HCl) 7,326,708 Anchen is enjoined from infringing the patent-in-suit.
All claims, counterclaims, affirmative defenses, and demands in this action are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Almirall, LLC v. Zydus Pharms. (USA) Inc., 20-0343 (D.N.J.) Aczone® (dapsone gel) 9,517,219 All claims and counterclaims are dismissed without prejudice.
Each party shall bear its own costs, attorneys’ fees, and expenses.
Zydus will not infringe the patent-in-suit pursuant except as provided for in the parties’ settlement agreement.
The stipulation and order shall not act as an adjudication on the merits.
Genzyme Corp. v. Aizant Drug Research Solutions Private Ltd., 18-1837, 19-1734 (D. Del.) Cerdelga® (eliglustat tablets) 7,196,205 6,916,802 7,253,185 7,615,573 The parties’ claims and counterclaims are dismissed with prejudice.
The parties shall bear their own costs.
Genzyme Corp. v. Apotex Inc., 18-1795 (D. Del.) Cerdelga® (eliglustat capsules) 7,196,205 The parties’ claims and counterclaims are dismissed with prejudice.
The parties shall bear their own costs.
Assertio Therapeutics, Inc. v. Patrin Pharma, Inc., 20-5055 (N.D. Ill.) Cambia® (diclofenac potassium powder for oral solution) 7,759,394 8,097,651 8,927,604 9,827,197 All affirmative defenses, claims, and counterclaims raised by Patrin are dismissed with prejudice.
Patrin is enjoined from infringing the patents-in-suit. Injunction shall continue with respect to each patent-in-suit until expiration, unless (i) earlier terminated or modified by further order of this Court, (ii) a final judgment from which no appeal can be taken that all of the asserted claims are unenforceable, or (iii) a final judgment from which no appeal can be or is taken that all of the asserted claims are invalid.
Nothing shall delay the effective date of approval of Patrin’s ANDA. Nothing shall affect the “Paragraph IV certifications” in Patrin’s ANDA. The parties waive all right to appeal.
Each party is to bear its own costs and attorney’s fees.
Celgene Corp. v. Apotex Inc., 18-0461, 19-6999, 19-13994 (D.N.J.) Revlimid® (lenalidomide capsules) 7,189,740 7,465,800 7,468,363 7,977,357 8,193,219 8,404,717 8,431,598 8,741,929 9,056,120 Until their expiration, Apotex is enjoined from infringing the patents-in-suit, except as 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 Apotex from maintaining a “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts the FDA from approving the Apotex ANDA.
Allergan, Inc. v. Gland Pharma Ltd., 20-0932 (D. Del.) Lastacaft® (alcaftadine ophthalmic solution) 8,664,215 10,617,695 Filing Gland’s ANDA was a technical act of infringement of the patents-in-suit. All claims, defenses, and counterclaims are dismissed without prejudice.
Absent a license, Gland is enjoined from infringing the patents-in-suit during the life of the patents-in-suit unless all of the claims are found invalid or unenforceable by a court decision from which no appeal has been taken.
The parties waive any right to appeal.
Bausch Health Cos. Inc. v. Actavis Labs. FL, Inc., 19-13722 (D.N.J.) Relistor® (methylnaltrexone bromide tablets) 10,307,417 All claims and counterclaims, defenses, motions and petitions asserted are dismissed without prejudice.
Each party will bear its own attorneys’ fees and costs.
Celgene Corp. v. Prinston Pharm. Inc., 18-11216 (D.N.J.) Otezla® (apremilast tablets) 7,427,638 10,092,541 Prinston admits that the patents-in-suit are valid and enforceable.
Prinston admits that at least one claim of the patents-in-suit would be infringed by its ANDA product. Until expiration of the patents-in-suit, Prinston 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.
Celgene Corp. v. Zydus Pharms. (USA) Inc., 17-2528, 18-8519 (D.N.J.) Revlimid® (lenalidomide capsules) 7,465,800 7,968,569 7,977,357 8,193,219 8,431,598 8,530,498 8,648,095 9,101,621 9,101,622 Until expiration of the patents-in-suit, Zydus is enjoined from infringing the patents-in-puit, unless specifically authorized by Celgene. Zydus is further enjoined from assisting or cooperating with any third parties in connection with any infringement of the patents-in-suit, unless specifically authorized by Celgene.
All counterclaims, affirmative defenses and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees. Nothing prohibits Zydus from filing and maintaining PIV certifications with respect to the patents-in-suit or any other patent in connection with Revlimid. Nothing prohibits Zydus from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving the Zydus ANDA.
AstraZeneca AB v. MSN Pharms., Inc., 18-2051 (D. Del.) Movantik® (naloxegol tablets) 9,012,469 Plaintiffs’ action against MSN and MSN’s action against Plaintiffs, including all claims and defenses asserted by Plaintiffs against MSN and all claims and defenses asserted by MSN against Plaintiffs, are dismissed with prejudice.
All parties shall bear their own costs, disbursements and attorneys’ fees.
Bausch Health US, LLC v. Mylan Pharms. Inc., 18-14305, 19-8233, 20-2749 (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 provisions of the Settlement Agreement, this case is dismissed with respect to Mylan, without prejudice. Mylan shall be entitled to contest the infringement, validity, and/or enforceability of the patents-in-suit pertaining to any product that is not the Mylan ANDA product.
Each party will bear its own attorneys’ fees and costs. Mylan is entitled to maintain its Paragraph IV certification to the patents-in-suit. The 30-month stay with respect to the approval of the Mylan’s ANDA is hereby terminated.
Mylan is entitled to pursue and obtain FDA approval for Mylan’s AND product prior to the expiration of the patents-in-suit.
Keryx Biopharmaceuticals, Inc. v. Chemo Research S.L., 19-0220 (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, counterclaims, 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.
Silvergate Pharms., Inc. v. CMP Development LLC, 20-0161 (D. Del.) Qbrelis® (Lisinopril oral solution) 9,463,183 9,616,096 9,814,751 10,039,800 10,265,370 10,406,199 N/A
Eagle Pharms., Inc. v. Accord Healthcare, Inc., 19-9031 (D.N.J.) Argatroban Injections 7,589,106 7,687,516 All claims and affirmative defenses are dismissed with prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Allergan Pharms. Int’l Ltd. v. Sun Pharm. Indus. Ltd., 20-10176 (D.N.J.) Asacol® (mesalamine delayed-release tablets) 9,089,492 The filing of Sun’s ANDA was a technical act of infringement of the ’492 patent. All other claims, defenses, and counterclaims asserted by the parties are dismissed without prejudice.
Unless otherwise agreed to by the Parties, Sun is enjoined from infringing the ’492 patent for the life of the patent, unless all of the claims of the ’492 patent 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.
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.
Parties’ claims are dismissed without prejudice.
Novo Nordisk Inc. v. Mylan Institutional LLC, 19-1551 (D. Del.) Victoza® (liraglutide recombinant solution for injection) 6,268,343 7,762,994 8,114,833 8,579,869 8,846,618 9,265,893 RE41,956 The parties dismiss all claims, counterclaims, and defenses asserted in this action without prejudice.
Each party will bear its own attorneys’ fees and costs

Oren D. Langer

Partner

Assistant Managing Partner, New York Office
Member of Executive Board

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