ANDA Litigation Settlements

Reported settlements in federal district court cases

First 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
Novo Nordisk Inc. v. Alvogen, Inc., MDL 22-MD-3038, 22-0294, 22-0299 (D. Del.)	Ozempic® (semaglutide injection)	9,132,239 9,687,611 10,220,155 11,097,063 RE46,363	All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. The parties waive any right to appeal.
Vifor Fresenius Medical Care Renal Pharma Ltd. v. Aurobindo Pharma Ltd., 23-0877 (D. Del.)	Velphoro® (sucroferric oxyhydroxide tablets)	9,561,251 10,624,855 10,682,376 10,695,367 10,925,896 10,925,897 10,933,090 11,013,761 11,013,762 11,234,938 11,446,252	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.
Vertex Pharms. Inc. v. Sun Pharm. Indus. Ltd., 20-0988, 23-0666 (D. Del.)	Kalydeco® (ivacaftor tablets)	10,646,481 11,564,916	The parties have entered into a settlement and license agreement with respect to Vertex’s claims. Sun will not make, have made, use, offer for sale, or sell the Sun product in the US except as provided for in the parties’ settlement and license agreement. All claims, counterclaims, and defenses are dismissed without prejudice and without costs or attorneys’ fees to any party.
Avion Pharms., LLC v. Lupin Ltd., 22-0729 (D. Del.)	Balcoltra® (levonorgestrel ethinyl estradiol / ferrous bisglycinate tablets)	7,838,042	All claims and defenses asserted by the parties are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 23-0926, 23-6667 (D.N.J.)	Yupelri® (revefenacin inhalation solution)	8,541,451 9,765,028 10,550,081 11,008,289 11,484,531 11,691,948 10,100,013 11,649,209 8,017,783 9,249,099	All claims, counterclaims, and affirmative defenses between Plaintiffs and Accord/Medichem are dismissed without prejudice. Accord and Medichem, except as licensed by Plaintiffs, will be enjoined until expiration of the patents-in-suit from infringing the patents-in-suit. Nothing shall prevent FDA from granting final approval to Accord’s ANDA. Each party will bear its own attorneys’ fees and costs.
Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 23-0926, 23-6667 (D.N.J.)	Yupelri® (revefenacin inhalation solution)	8,541,451 9,765,028 10,550,081 11,008,289 11,484,531 11,691,948 10,100,013 11,649,209 8,017,783 9,249,099	All claims, counterclaims, and affirmative defenses between Plaintiffs and Orbicular are dismissed without prejudice. Orbicular, except as licensed by Plaintiffs, will be enjoined until expiration of the patents-in-suit from infringing the patents-in-suit. Nothing shall prevent FDA from granting final approval to Orbicular’s ANDA. Each party will bear its own attorneys’ fees and costs.
Supernus Pharms., Inc. v. Ajanta Pharma Ltd., 22-1431 (D. Del.)	Oxtellar XR® (oxcarbazepine extended-release tablets)	7,722,898 7,910,131 8,617,600 8,821,930 9,119,791 9,351,975 9,370,525 9,855,278 10,220,042 11,166,960	All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Adverio Pharma GmbH v. Alembic Pharms. Ltd., 22-6104, 23-1285 (D.N.J.)	Adempas® (riociguat tablets)	7,173,037 10,662,188 11,203,593	All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Veloxis Pharms., Inc. v. Accord Healthcare, Inc., 22-0909 (D. Del.)	Envarsus XR® (tacrolimus extended-release tablets)	8,685,998 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, Accord is enjoined from infringing the patents-in-suit, unless specifically authorized by Veloxis. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Accord from maintaining a “Paragraph IV Certification” with respect to the patents-in-suit. Nothing restricts FDA from approving Accord’s ANDA.
Novartis Pharms. Corp. v. Accord Healthcare Inc., 22-0744 (D. Del.)	Rydapt® (midostaurin capsules)	7,973,031	All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. The parties waive any right to appeal. Nothing restricts FDA from approving Accord’s ANDA.
Bayer Pharma AG v. Macleods Pharms. Ltd., 23-0665 (D. Del.)	Xarelto® (rivaroxaban tablets)	10,828,310	All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
AbbVie Inc. v. Alkem Labs. Ltd., 22-1423 (D. Del.)	Orilissa® (elagolix sodium tablets)	10,537,572 10,682,351 11,344,551 11,542,239	The filing of Alkem’s ANDA was an act of infringement of each of the patents-in-suit. All other claims, counterclaims, and defenses are dismissed without prejudice. Absent a license or authorization by AbbVie, Alkem is enjoined from infringing the patents-in-suit during the life of the patents-in-suit. The parties waive any right to appeal. Nothing prohibits Alkem from maintaining a Paragraph IV Certification with respect to the patents-in-suit. Each party will bear its own attorneys’ fees and costs. The stipulation and order is without prejudice to any claim, defense, or counterclaim in any possible future action between Alkem and AbbVie regarding any of the patents-in-suit and a product other than Alkem’s ANDA product.
AbbVie Inc. v. Sandoz, Inc., 23-1212 (D. Del.)	Orilissa® (elagolix sodium tablets)	11,542,239 11,690,845 11,690,854 11,707,464	The filing of Sandoz’s ANDA was an act of infringement of each of the patents-in-suit. All other claims, counterclaims, and defenses are dismissed without prejudice. Sandoz is enjoined from infringing the patents-in-suit during the life of the patents-in-suit absent a license agreement or other authorization by AbbVie. The parties waive any right to appeal. The stipulation is without prejudice to any claim, defense, or counterclaim in any possible future action between Sandoz and AbbVie regarding the patents-in-suit and a product other than Sandoz’s ANDA product. Nothing prohibits Sandoz from maintaining a Paragraph IV certification to the patents-in-suit in its ANDA and nothing prevents FDA from granting approval of Sandoz’s ANDA. The 30-month stay is terminated as of the date of this stipulation and order.
Indivior Inc. v. Teva Pharms. USA, Inc., 17-7115, 18-1777, 18-5300 (D.N.J.)	Suboxone® (buprenorphine HCl / naloxone HCl sublingual film)	9,687,454 9,855,221 9,931,305	All claims, counterclaims, and affirmative defenses are dismissed with prejudice, and without costs or attorneys’ fees to the parties.
Azurity Pharms., Inc. v. Alkem Labs. Ltd., 22-0940 (D. Del.)	Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets)	7,157,584 7,572,920 9,066,936 9,169,238 9,387,249	All claims, counterclaims, and defenses are dismissed without prejudice. The parties shall bear their own attorney fees and costs.
Azurity Pharms., Inc. v. Saba Ilac Sanayii Ve Ticaret AS, 22-0353 (D. Del.)	Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets)	7,157,584 7,572,920 9,066,936	All claims, counterclaims, and defenses are dismissed without prejudice. The parties shall bear their own attorney fees and costs.
ZS Pharma, Inc. v. Alkem Labs. Ltd., 22-1096, 23-1187 (D. Del.)	Lokelma® (sodium zirconium cyclosilicate for oral suspension)	8,877,255 9,592,253 9,913,860 10,300,087 10,695,365 11,738,044	Unless specifically authorized pursuant to 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.
Aerie Pharms., Inc. v. Micro Labs Ltd., 22-1365 (D.N.J.)	Rhopressa® (netarsudil ophthalmic solution)	8,394,826 10,174,017 10,654,844 11,028,081 9,415,043 9,931,336 11,185,538 10,588,901 9,993,470 11,197,853	All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Arbor Pharms., LLC v. Saba Ilac Sanayi ve Ticaret AS, 22-0353 (D. Del.)	Edarbi® (azilsartan medoxomil tablets)	7,157,584 7,572,920 9,066,936	All claims, counterclaims, and defenses are dismissed without prejudice. The parties shall bear their own attorney fees and costs.
Novartis Pharms. Corp. v. Alembic Global Holding SA, Ltd., 19-2021, 20-0074, 22-1395 (D. Del.)	Entresto® (sacubitril / valsartan tablets)	8,101,659 8,877,938 9,388,134 11,058,667 11,096,918	Sealed.
Celgene Corp. v. Amneal Pharms. of NY, LLC, 24-0500 (D.N.J.)	Revlimid® (lenalidomide capsules)	7,465,800 7,855,217	Until expiration of the patents-in-suit, Amneal is enjoined from infringing the patents-in-suit, unless 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 Amneal from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing prohibits Amneal from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts FDA from approving Amneal’s ANDA.
Chemo Research SL v. Encube Ethicals Private, Ltd., 22-0854 (D. Del.)	Nuvessa® (metronidazole vaginal gel)	7,893,097 8,658,678 8,877,792 8,946,276 9,198,858 10,238,634 10,596,155	Encube is enjoined from infringing the patents-in-suit. The patents-in-suit are valid and enforceable, and Encube waives all right to challenge the validity and enforceability of such claims with respect to its ANDA product. In the absence of a license, Encube would infringe the patents-in-suit. Judgment on the basis of infringement by Encube of the patents-in-suit with is entered in favor of Plaintiffs. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Encube is entitled to maintain its Paragraph IV certifications to the asserted patents.
Bayer Healthcare LLC v. Padagis Israel Pharms. Ltd., 23-1148 (D. Del.)	Astepro® (azelastine HCl nasal spray)	8,071,073 8,518,919 9,919,050	All claims and defenses are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Novo Nordisk Inc. v. ScinoPharm Taiwan Ltd., 23-20935 (D.N.J.)	Victoza® (liraglutide recombinant solution injection)	8,114,833 9,265,893	The parties have resolved the action. All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Nothing prohibits ScinoPharm from maintaining a Paragraph IV certification to the patents-at-issue in the ScinoPharm ANDA or prevents FDA from granting final approval of the ScinoPharm ANDA. Each party will bear its own attorneys’ fees and costs.
Actelion Pharms. US, Inc. v. Lupin Ltd., 23-0150 (D. Del.)	Uptravi® (selexipag for injection)	8,791,122 9,284,280	Lupin agrees the patents-in-suit are valid and enforceable. Unless authorized by Plaintiffs, Lupin is enjoined from infringing the patents-in-suit until and after the expiration of the patents-in-suit. Parties waive all right to appeal. All claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees.
AstraZeneca AB v. ScieGen Pharms., Inc., 23-1457 (D. Del.)	Brilinta® (ticagrelor tablets)	10,300,065	Unless specifically authorized, ScieGen 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.
Bayer Intellectual Property GmbH v. Indoco Remedies Ltd., 23-0690 (D. Del.)	Xarelto® (rivaroxaban tablets)	9,539,218 10,828,310	All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Bayer Intellectual Property GmbH v. Apotex Inc., 23-0327 (D. Del.)	Xarelto® (rivaroxaban tablets)	9,539,218	All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Celgene Corp. v. MSN Labs. Private Ltd., 23-0699 (D. Del.)	Onureg® (azacitidine tablets)	8,846,628 11,571,436	Until expiration of the patents-in-suit, MSN is enjoined from infringing the patents-in-suit, unless specifically authorized by Plaintiffs. All claims, counterclaims, affirmative defenses, motions, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits MSN from maintaining any Paragraph IV Certifications with respect to the patents-in-suit or any other patent. Nothing restricts FDA from approving MSN’s ANDA. Nothing prohibits MSN from engaging in any activity permitted under 35 U.S.C. § 271(e)(1).
Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialities Ltd., 23-0926, 23-6667, 24-0150 (D.N.J.)	Yupelri® (revefenacin inhalation solution)	8,541,451 9,765,028 10,550,081 11,008,289 11,484,531 11,691,948 8,017,783 9,249,099 10,100,013 11,649,209 11,858,898	The parties agree that all claims, counterclaims, and affirmative defenses are dismissed without prejudice. Lupin, except as expressly licensed by Plaintiffs, is enjoined until expiration of the patents-in-suit from infringing the patents-in-suit. Nothing shall prevent FDA from granting final approval to Lupin’s ANDA at any time. Each party will bear its own attorneys’ fees and costs.
Novartis Pharms. Corp. v. Novugen Oncology Sdn. Bhd., 23-1449 (D. Del.)	Mekinist® (trametinib dimethyl sulfoxide tablets)	7,378,423 8,580,304 9,155,706 9,271,94 9,399,021	Plaintiffs dismiss the action without prejudice.
Intercept Pharms., Inc. v. Zenara Pharma Private Ltd., 22-1215 (D. Del.)	Ocaliva® (obeticholic acid tablets)	9,238,673 10,047,117 10,052,337 10,174,073 10,751,349 10,758,549	Except as specifically authorized pursuant to the settlement agreement, Zenara is enjoined from infringing the patents-in-suit. Nothing prevents FDA from granting final approval to Zenara’s ANDA. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Fresenius Kabi USA, LLC v. Caplin Steriles Ltd., 23-1144 (D. Del.)	Naropin® (ropivacaine HCl injection)	7,828,787 7,857,802	Plaintiffs dismiss the complaint.
Bristol-Myers Squibb Co. v. Zydus Pharms. (USA) Inc., 23-21098 (D.N.J.)	Sprycel® (dasatinib tablets)	7,491,725 8,680,103	All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Azurity Pharms., Inc. v. Cosette Pharms., Inc., 23-3830 (D.N.J.)	Firvanq® (vancomycin HCl oral solution)	11,638,692	All claims and counterclaims are dismissed without prejudice. The parties shall bear their own fees and costs.
Acerta Pharma B.V. v. Sandoz Inc., 22-0164 (D. Del.)	Calquence® (acalabrutinib capsules)	9,290,504 9,758,524 10,239,883 9,796,721 10,167,291 10,272,083	Except as specifically authorized pursuant to the settlement agreement, Sandoz is enjoined from infringing the patents-in-suit. All claims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees. The parties agree that the 30-month stay with respect to the approval of the Sandoz ANDA is terminated. Nothing prohibits Sandoz from maintaining a Paragraph IV Certification with respect to the Sandoz ANDA products. Nothing restricts FDA from approving the Sandoz ANDA.
Impact Biomedicines, Inc. v. Teva Pharms., Inc., 23-21385 (D.N.J.)	Inrebic® (fedratinib capsules)	10,391,094 11,400,092	Until expiration of the patents-in-suit, Teva is enjoined from infringing the patents-in-suit, except as specifically authorized by Impact. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorney fees to either party. Nothing prohibits Teva from maintainng any Paragraph IV Certification with respect to the patents-in-suit. Nothing restricts FDA from approving Teva’s ANDA.
Novo Nordisk Inc. v. Biocon Pharma Ltd., 22-0937 (D. Del.)	Saxenda® (liraglutide recombinant solution injection)	8,920,383 9,265,893 9,775,953	The parties have agreed a negotiated settlement. All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Nothing prohibits Biocon from maintaining or filing a Paragraph IV certification in the Biocon ANDA and from serving the required notice letters for the purposes of receiving or maintaining final approval of the Biocon ANDA, or prevents FDA from granting final approval of the Biocon ANDA. Each party will bear its own attorneys’ fees and costs.
Novo Nordisk Inc. v. Dr. Reddy’s Labs., Ltd., 23-22112 (D.N.J.)	Victoza® (liraglutide recombinant solution injection)	8,114,833 9,265,893	All claims, counterclaims, and affirmative defenses between the parties concerning the patents-in-suit are dismissed without prejudice. Nothing prohibits DRL from maintaining a Paragraph IV certification to the patents-in-suit in the DRL ANDA for the purposes of receiving or maintaining final approval of the DRL ANDA, or prevents FDA from granting final approval of the DRL ANDA. Each party will bear its own attorneys’ fees and costs.
Taiho Pharm. Co., Ltd. v. Accord Healthcare Inc., 19-2321, 21-0838 (D. Del.)	Lonsurf® (tipiracil HCl / trifluridine tablets)	10,960,004 RE46,284 9,527,833 10,457,666	All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
AbbVie Inc. v. Sun Pharm. Indus. Ltd., 22-1423, 24-0153 (D. Del.)	Orilissa® (elagolix sodium tablets)	7,419,983 10,537,572 10,682,351 11,542,239 11,690,845 11,690,854	The filing of Sun’s ANDA was a technical act of infringement of each of the ’572, ’351, ’854, ’845, and ’239 patents. All other claims and defenses are dismissed without prejudice. Sun is enjoined from infringing the patents-in-suit absent a license agreement or other authorization by AbbVie, unless all of the claims of the ’983 Patent, the ’572 Patent, the ’351 Patent, and the ’239 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. This order is without prejudice to any claim, defense, or counterclaim in any possible future action between Sun and AbbVie regarding any of the patents-in-suit and a product other than Sun’s ANDA.
Galderma Labs., L.P. v. Teva Pharms., Inc., 24-0197 (D.N.J.)	Aklief® (trifarotene cream)	9,084,778 9,498,465	The patents-in-suit are valid and enforceable. All affirmative defenses, claims, and counterclaims, are dismissed with prejudice. In the absence of a license, Teva would infringe the patents-in-suit. Except as otherwise authorized or licensed by Plaintiffs, Teva is enjoined from infringing the patents-in-suit until the expiration of the patents-in-suit, except as otherwise authorized or licensed by Plaintiffs. Any Protective Order entered by the Court in this action shall remain in full force and effect. The parties waive all right to appeal. Each party is to bear its own costs, expenses, and attorneys’ fees. The 30-month stay is terminated. Nothing prohibits Teva from maintaining Paragraph IV certifications in Teva’s ANDA and nothing prohibits FDA from finally approving Teva’s ANDA.
Novo Nordisk Inc. v. Lupin Ltd., 23-4027 (D.N.J.)	Victoza® (liraglutide recombinant solution injection)	8,114,833 9,265,893	All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Nothing prohibits Lupin from maintaining a Paragraph IV certification to the patents-at-issue in the Lupin ANDA for the purposes of receiving final approval of the Lupin ANDA, or prevents FDA from granting final approval of the Lupin ANDA. Each party will bear its own attorneys’ fees and costs.
Bayer Intellectual Property GmbH v. Umedica Labs. Pvt. Ltd., 23-1456 (D. Del.)	Xarelto® (rivaroxaban tablets)	9,539,218 10,828,310	All claims and defenses asserted by the parties are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Galderma Labs., L.P. v. Apotex Inc., 22-0724 (D. Del.)	Oracea® (doxycycline capsules)	7,749,532 8,206,740	All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.