ANDA Litigation Settlements

November 2019

Case Name	Drug	Patent No(s).	Publicly Available Terms
Ferring Pharms. Inc. v. Hetero USA Inc., 19-0634 (D. Del.)	Prepopik® (citric acid / magnesium oxide / sodium picosulfate oral solution)	8,450,338 8,481,083	N/A
Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., 17-6921 (D.N.J.)	Entereg® (alvimopan capsules)	6,469,030 8,946,262	N/A
Genentech, Inc. v. Granules Pharms., Inc., 19-0164 (D. Del.)	Esbriet® (pirfenidone tablets)	8,383,150 8,420,674 8,778,947	Granules is enjoined from making and selling its ANDA product on a date that is earlier than the expiration date of the last to expire of the Orange Book Patents and/or additional periods of exclusivity to which Plaintiffs are or become entitled. If Granules converts its “Paragraph III” certifications into “Paragraph IV” certifications, it shall notify plaintiffs within 10 business days. All claims and counterclaims are dismissed without prejudice. The parties shall bear their own costs and attorney fees.
Merck Sharp & Dohme Corp. v. Mylan Labs. Ltd., 18-0450 (D. Del.)	Noxafil® (posaconazole for injection)	9,023,790 9,358,297	Mylan is enjoined from infringing the patents-in-suit by making, using, or selling its ANDA product. Compliance with the Consent Judgment may be enforced by Merck and its successors in interest, or assigns, as permitted by the terms of the Settlement Agreement. The court retains jurisdiction to enforce or supervise performance under this Consent Judgment and the Settlement Agreement. All claims, counterclaims, affirmative defenses and demands in this action are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Kaleo, Inc. v. Adamis Pharms. Corp., 19-0917 (D. Del.)	Evzio® (naloxone HCl for injection)	9,022,022 10,143,792 10,238,806	Plaintiff dismisses action without prejudice. Defendant has not yet filed an answer or a motion for summary judgment.
Helsinn Healthcare S.A. v. Baxter Healthcare Corp., 18-1674 (D. Del.)	Aloxi® (palonosetron HCl for injection)	8,598,219 8,729,094	Helsinn’s claims are dismissed without prejudice. The court retains jurisdiction over Helsinn and Baxter for purposes of enforcing the Dismissal Order.
Valeant Pharms. Int’l v. Sun Pharm. Indus., Ltd., 18-17312 (D.N.J.)	Uceris® (budesonide tablets)	10,064,878	All claims and counterclaims, defenses, motions and petitions are dismissed without prejudice. Each party to bear its own costs and attorneys’ fees. The parties waive any right to appeal or otherwise move for relief. Court retains jurisdiction over the parties for purposes of enforcing the stipulation and order.
Adamis Pharms. Corp. v. Belcher Pharms., LLC, 18-2379 (M.D. Fla.)	Symjepi® (epinephrine for injection)	9,283,197 10,004,700	All claims and defenses in this action shall be dismissed with prejudice with all parties to bear their own fees and costs. The matters in controversy have been resolved pursuant to a mutual release and covenant not to sue, the terms of which have been mutually agreed-upon by the parties.
Eli Lilly and Co. v. Nang Kuang Pharm. Co. Ltd., 14-01647 (S.D. Ind.)	Alimta® (pemetrexed disodium for intravenous infusion)	5,344,932 7,772,209	All claims, affirmative defenses, and counterclaims between Lilly and Sandoz are dismissed without prejudice. Lilly and Sandoz will each bear their own costs and fees.
Shionogi Inc. v. Zydus Pharms. (USA) Inc., 18-12898 (D.N.J.)	Fortamet® (metformin HCl extended-release tablets)	6,790,459 6,866,866	All claims and counterclaims are dismissed with prejudice with each party bearing its own costs and fees.
Shionogi Inc. v. Amneal Pharms. LLC, 18-1564 (D. Del.)	Fortamet® (metformin HCl extended-release tablets)	6,790,459 6,866,866	All claims and counterclaims are dismissed with prejudice with each party bearing its own costs and fees.
Salix Pharms., Inc. v. Teva Pharms. USA, Inc., 17-0329 (D. Del.)	Apriso® (mesalamine extended-release capsules)	8,865,688	Absent a license, certain claims of the ’688 patent would be infringed by the ANDA product as defined in the parties’ settlement agreement. Teva is enjoined until the expiration of the ’688 patent from making and selling its ANDA product. Teva shall be entitled to contest the infringement, validity and/or enforceability of the ’688 patent pertaining to any product that is not the ANDA product and is not the subject of Tevas ANDA. Each party will bear its own attorneys’ fees and costs. Teva is entitled to maintain its Paragraph IV certification to the ’688 patent and each party acknowledges and agrees that the 30-month stay with respect to the approval of the Teva ANDA is hereby terminated.
Meda Pharms. Inc. v. Aurobindo Pharma Ltd., 19-5501 (D.N.J.)	Astepro® (azelastine HCl nasal spray)	8,071,073 8,518,919 9,919,050	All claims and counterclaims are dismissed with prejudice with each party bearing its own costs and fees.
Keryx Biopharms., Inc. v. Par Pharm., Inc., 19-0955 (D. Del.)	Auryxia® (ferric citrate tablets)	8,093,423 9,387,191	Plaintiffs and Defendant Par have reached an agreement to settle the claims and counterclaims asserted in the case. Litigation between the parties is stayed for 30 days to permit review of the settlement agreement by certain government authorities. If the parties have not filed a stipulation of dismissal within that time, they shall contact the Court to report on the status of the settlement.
Taro Pharms U.S.A., Inc. v. Lupin Ltd., 18-4225 (D.N.J.)	Topicort® (desoximetasone topical spray)	8,277,780 8,715,624	Taro and Lupin agree that all claims, counterclaims, and affirmative defenses are dismissed without prejudice with each party to bear its own costs and attorneys’ fees.
Valeant Pharms. North America LLC v. Apotex Inc., 18-14202, 19-5939 (D.N.J.)	Jublia® (efinaconazole topical solution)	10,105,444 7,214,506 8,039,494 8,486,978 9,302,009 9,566,272 9,662,394 9,861,698 9,877,955	All claims are dismissed without prejudice. The parties waive any right of appeal. Each party shall bear its own costs and fees.
Genentech, Inc. v. Torrent Pharms. Ltd., 19-0324 (D. Del.)	Esbriet® (pirfenidone tablets)	8,383,150 8,778,947	Torrent has not refiled its ANDA. In the event that Torrent refiles its ANDA, Torrent will provide written notice to Plaintiffs and consent to jurisdiction should Plaintiffs recommence suit. All claims and counterlaims are dismissed without prejudice. The parties shall bear their own costs and attorney fees.
Genentech, Inc. v. SciGen Pharms. Inc., 19-0131, 19-0132 (D. Del.)	Esbriet® (pirfenidone capsules and tablets)	9,561,217 8,383,150 8,420,674 7,767,225 7,988,994 8,753,679	Complaint and counterlcaims are dismissed without prejudice with each party to bear its own costs and fees.
Astellas Pharma Inc. v. Zydus Pharms. (USA), Inc., 16-0924 (D. Del.)	Myrbetriq® (mirabegron extended-release tablets)	7,342,117 7,982,049 8,835,474 RE44,872	N/A
Astellas Pharma Inc. v. Sawai Pharm. Co., Ltd., 16-0954 (D. Del.)	Myrbetriq® (mirabegron extended-release tablets)	6,346,532 7,342,117 7,982,049 8,835,474 RE44,872	N/A
Endo Pharms. Inc. v. Perrigo UK Finco Ltd., 19-0437 (D. Del.)	Nascobal® (cyanocobalamin nasal spray)	7,229,636 7,404,489 7,879,349 8,003,353 8,940,714 9,415,007	The patents-in-suit are valid and enforceable as it concerns the Perrigo ANDA product. Perrigo may challenge the validity, enforceability and/or infringement of the patents-in-suit in any action or proceeding involving any Perrigo products other than ANDA No. 212458. Perrigo’s ANDA product infringes the patents-in-suit and Perrigo is enjoined from making and selling its ANDA product until permitted to do so under the settlement agreement. All claims, counterclaims, affirmative defenses, and demands of the parties in this action are hereby dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any Party. The parties expressly waive any right to appeal from this Consent Judgment.
Actelion Pharms. Ltd. v. Sun Pharm. Indus., Inc., 17-5015 (D.N.J.)	Veletri® (epoprostenol sodium for injection)	8,598,227	Sun’s ANDA product infringes the patent-in-suit. The asserted claims are valid and enforceable as against Sun’s ANDA product. Sun is enjoined from making and selling its ANDA product until the expiration of the patent-in-suit other than as recognized by the parties. Nothing should prevent Sun from maintaining its Paragraph IV certification against the patent-in-suit or prevent the FDA from approvign Sun’s ANDA. The Feb. 15, 2019 Markman Order is vacated. All affirmative defenses, claims, and counterclaims are dismssed without prejudice with each party to bear its own fees and costs. No appeal from this judgment and order may be taken.
Medicure Int’l, Inc. v. Gland Pharma Ltd., 18-16246 (D.N.J.)	Aggrastat® (tirofiban HCl for injection)	6,770,660	Claims 1-5 of the patent-in-suit are valid and enforceable. All affirmative defenses, claims, and counterclaims are dismissed with prejudice. Defendant’s ANDA product infringes claims 1-5 of the patent-in-suit, and judgment of infringement is entered. Defendant is enjoined until the expiration of the patent-in-suit from making and selling its ANDA product during the term of the patent-in-suit. The parties waive all right to appeal. Each party to bear its own costs and fees. Nothing shall prohibit or restrict Defendant from maintaining or filing Paragraph IV certifications in Gland’s ANDA No. 206888 and nothing herein shall prohibit FDA from reviewing or approving Gland’s ANDA No. 206888.
Sun Pharm. Indus. Ltd. v. Vistapharm, Inc., 19-7536 (D.N.J.)	Riomet® (metformin HCl oral solution)	6,890,957	All claims, defenses, and counterclaims are dismissed without prejudice. Each party bears its own costs, expenses, and attorneys’ fees.
Eisai Co. v. Glenmark Pharms. Ltd., 19-1214 (D. Del.)	Banzel® (rufinamide oral suspension)	6,740,669	The patent-in-suit is valid and enforceable. All affirmative defenses, claims, and counterclaims are dismissed with prejudice and without costs, disbursements or, except as set forth in the settlement agreement, fees. Glenmark’s ANDA product infringes the patent-in-suit and it is enjoined from making and selling its ANDA product until the license contemplated by the Settleemnt Agreement becomes effective.
Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc., 17-0374 (D. Del.)	Eliquis® (apixaban tablets)	6,967,208 9,326,945	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 or otherwise move for relief from the stipulation and order.
Mallinckrodt Hospital Products IP Ltd. v. Altan Pharma Ltd., 19-0552 (D. Del.)	Ofirmev® (acetaminophen for injection)	9,399,012 9,610,265 9,987,238 6,992,218	Altan’s NDA product infringes the patents-in-suit. Unless otherwise permitted pursuant to the settlement agreements or authorized under 35 U.S.C. § 27l(e)(l), Altan is enjoined from making and selling its NDA product. All claims and demands for relief prayed for by the parties are deemed to be satisfied. In the event of any further action, the parties waive all defenses based on personal jurisdiction, subject matter jurisdiction, and venue. Each party shall bear its own costs, disbursements and attorneys' fees. The parties waive any right to appeal.
Celgene Corp. v. Glenmark Pharms. Ltd., 18-11158 (D.N.J.)	Otezla® (apremilast tablets)	6,962,940 7,208,516 7,427,638 7,659,302 7,893,101 8,455,536 8,802,717 9,018,243 9,872,854	Until the expiration of the patents-in-suit Glenmark is enjoined from making and selling its ANDA product. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs and attorneys’ fees.
Gilead Sciences, Inc. v. Zydus Pharms. (USA) Inc., 19-0529 (D.N.J.)	Truvada® (emtricitabine / tenofovir disoproxil fumarate tablets)	6,642,245 6,703,396 8,592,397 8,716,264 9,457,036 9,744,181	Either party may write to the Court to reopen and restore the docket within 60 days after discussions between the parties to cure any objections raised by the FTC and/or DOJ. All claims, counterclaims, affirmative defenses, and causes of action are dismissed with prejudice and without costs and attorneys’ fees.
Mylan Specialty L.P. v. Aurobindo Pharma USA Inc., 18-15190 (D.N.J.)	AccuNeb® (albuterol sulfate inhaler)	6,702,997	All claims, counterclaims, affirmative defenses, and causes of action are dismissed without prejudice and without costs and attorneys’ fees.
Astellas Pharma Inc. v. Eugia Pharma Specialties Ltd., 18-0757 (D. Del.)	Xtandi® (enzalutamide capsules)	7,709,517 8,183,274 9,126,941	Plaintiffs’ claims and Aurobindo’s counterclaims are dismissed with prejudice. Each party shall bear its own costs. Court retains jurisdiction to enforce the dismissal order and terms of parties’ settlement agreement.
Mitsubishi Tanabe Pharma Corp. v. Apotex, Inc., 17-5278 (D.N.J.)	Invokana® (canagliflozin tablets)	7,943,582 8,513,202	The submission of Apotex’s ANDA to the FDA for the purpose of obtaining regulatory approval to make and sell generic Invokana was a technical act of patent infringement. The asserted claims of each of the patents-in-suit are valid and enforceable. Apotex is enjoined from manufacturing, using, offering for sale, selling in the US, or into the US, the Apotex ANDA product until the expiration of the patents-in-suit. All affirmative defenses, claims and counterclaims are dismissed with prejudice. The parties shall bear their own fees and costs. The parties waive all right to appeal.
Arbor Pharms., LLC v. Teva Pharms. USA, Inc., 19-0053 (D. Del.)	Sklice® (ivermectin lotion)	8,791,153 8,927,595	The parties entered into a settlement agreement as of Sept. 5, 2019. All claims, counterclaims, and defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Millennium Pharms., Inc. v. Zydus Pharms. (USA) Inc., 17-0423 (D. Del.)	Velcade® (bortezomib for injection)	6,713,446 6,958,319	Absent a license or other authorization from Millennium, Zydus’s ANDA Product infringes claims 20, 31, 49, and 53 of the 446 patent. The asserted claims have not been found to be invalid or unenforceable. The effective date of any FDA approval of Zydus’s ANDA shall not be earlier than May 1, 2022. Defendants are enjoined enjoined from selling and making the ANDA product prior to January 25, 2022, and are further enjoined from engaging in the commercial sale of the ANDA product prior to May 1, 2022. The court will retain jurisdiction to modify the judgment in accordance with the parties’ related agreements resolving this case. The parties shall bear their own costs, expenses, and attorneys’ fees.
Astellas Pharma Inc. v. Actavis Elizabeth LLC, 16-0905 (D. Del.)	Myrbetriq® (mirabegron extended-release tablets)	6,346,532 7,342,117 7,982,049 8,835,474 RE44,872	All claims and counterclaims in this action between parties are dismissed without prejudice with each party to bear its own costs and attorneys’ fees. The court shall retain jurisdiction over the settlement agreement in this case.
Osi Pharms., LLC v. Zydus Pharms. (USA) Inc., 19-0741 (D. Del.)	Tarceva® (erlotinib HCl tablets)	6,900,221	The complaint is dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Mayne Pharma Int’l Pty Ltd. v. Prinston Pharm. Inc., 19-0549 (D. Del.)	Doryx® MPC (doxycycline hyclate delayed-release tablets)	9,295,652 9,446,057 9,511,031	Each asserted claim of each of the patents-in-suit is valid and enforceable, and would be infringed by Prinston’s ANDA product. Prinston is enjoined from making and selling its ANDA product unless otherwise authorized under the settlement agreement. Prinston shall be entitled to contest the infringement, validity and/or enforceability of the patents-in-suit in any future litigation pertaining to any product that is not the Prinston ANDA product. Prinston is entitled to maintain its Paragraph IV certification to the patents-in-suit. The thirty-month stay with respect to the approval of the Prinston ANDA is terminated. The stipulated consent judgment and injunction does not affect FDA’s ability to grant final approval of the Prinston ANDA product. All claims, counterclaims, affirmative defenses and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to either party.
Indivior Inc. v. Actavis Labs. UT, Inc., 18-0497, 18-0499 (D. Del.)	Suboxone® (buprenorphine HCl / naloxone HCl sublingual film)	9,931,305 9,687,454	All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. The parties each expressly waive any right to appeal or otherwise move for relief from the stipulation and order.
West-ward Pharms. Corp. v. Granules Pharms., Inc., 18-0085 (D. Del.)	Mitigare® (colchicine capsules)	8,927,607 9,399,036 9,555,029 9,675,613 9,789,108	All claims, counterclaims, and affirmative defenses are dismissed without prejudice, with each party to bear its own costs and attorneys’ fees.
Celgene Corp. v. West-ward Pharms. Int’l Ltd., 18-13477 (D.N.J.)	Thalomid® (thalidomide capsules)	6,315,720 6,561,977 6,755,784 6,869,399 7,141,018 7,230,012 7,959,566 8,315,886 8,626,531	All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Symed Labs Ltd. v. Hikma Pharms. USA, Inc., 15-8304 (D.N.J.)	Zyvox® (linezolid tablets)	7,714,128	The ’128 patent is valid and enforceable. All claims and counterclaims are dismissed with prejudice. Each party shall bear its own costs, expenses and attorneys’ fees. The court retains jurisdiction over the parties, and the interpretation of the settlement agreement as it pertains to this dismissal.
Cipla Ltd. v. AstraZeneca AB, 19-0733 (D. Del.)	Nexium® (esomeprazole magnesium delayed-release oral suspension)	6,428,810	N/A
Noven Pharms., Inc. v. Actavis Labs. UT, Inc., 18-0758 (D. Del.)	Minivelle® (estradiol transdermal system)	9,730,900 9,724,310 9,833,419	N/A