ANDA Litigation Settlements

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
American Regent, Inc. v. Steriscience Pte. Ltd., 24-7809 (D.N.J.)	Selenious Acid	11,998,565	Unless otherwise authorized, Steriscience is enjoined from infringing the ’565 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall preclude FDA from granting final approval to Steriscience’s ANDA.
ZS Pharma, Inc. v. Sandoz Inc., 22-1101, 23-1191 (D. Del.)	Lokelma® (sodium zirconium cyclosilicate for oral suspension)	8,802,152 8,808,750 8,877,255 9,592,253 9,844,567 9,861,658 9,913,860 10,300,087 10,335,432 10,398,730 10,413,569 10,695,365 11,406,662 11,738,044	Unless otherwise authorized pursuant to the settlement agreement, Sandoz 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.
ZS Pharma, Inc. v. Ascent Pharms. Inc., 22-1099, 23-1188 (D. Del.)	Lokelma® (sodium zirconium cyclosilicate oral suspension)	8,802,152 8,808,750 8,877,255 9,592,253 9,844,567 9,861,658 9,913,860 10,300,087 10,335,432 10,398,730 10,413,569 10,695,365 11,738,044	Unless otherwise authorized pursuant to the settlement agreement, Ascent 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.
Novo Nordisk Inc. v. Rio Biopharmaceuticals, Inc., 24-0688 (D.N.J.)	Saxenda® (liraglutide injection solution)	8,114,833 8,684,969 8,920,383 9,108,002 9,132,239 9,457,154 9,616,180 9,687,611 9,775,953 9,861,757 10,220,155 10,357,616 10,376,652 11,097,063 11,311,679 11,446,443 RE46,363	All claims, counterclaims, and affirmative defenses between Novo Nordisk and Rio concerning the patents-in-suit are dismissed without prejudice. Nothing prohibits Rio from maintaining a Paragraph IV certification to the patents-in-suit in the Rio ANDA for the purposes of receiving or maintaining final approval of the Rio ANDA, or prevents FDA from granting final approval of the Rio ANDA. Each party will bear its own attorneys’ fees and costs.
Fresenius Kabi USA, LLC v. Accord Healthcare Inc., 24-5674 (D.N.J.)	levothyroxine sodium injection	10,398,669 11,135,190	Fresenius dismissed the case against Accord.
AbbVie Inc. v. Alembic Pharms. Ltd., 20-1009 (D. Del.)	Venclexta® (venetoclax tablets)	10,993,942 11,110,087 11,369,599 11,590,128	Alembic admits that the patents-in-suit are enforceable, valid, and would be infringed by Alembic’s ANDA product. The submission of Alembic’s ANDA was an act of infringement under 35 U.S.C. § 271(e)(2)(A). All other claims, counterclaims, and defenses are dismissed without prejudice. Alembic is enjoined from infringing the patents-in-suit during the life of the patents-in-suit including any extensions and pediatric exclusivities thereof, absent a license agreement or other authorization by Plaintiffs. The parties waive any right to appeal. The dismissal is without prejudice to any claim, defense, or counterclaim in any possible future action between Alembic and any of the Plaintiffs regarding the patents-in-suit and a product other than the Alembic ANDA product.
Otsuka Pharm. Co., Ltd. v. Teva Pharms. Inc., 22-0513 (D. Del.)	Jynarque® (tolvaptan tablets)	8,501,730 10,905,694	All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Each party will bear its own attorneys’ fees and costs.
Eisai R&D Management Co., Ltd. v. Dr. Reddy’s Labs., Inc., 24-6765 (D.N.J.)	Lenvima® (lenvatinib mesylate capsules)	7,612,208	The filing of DRL’s ANDA does not and will not infringe the ’208 patent. DRL’s ANDA product does not infringe the ’208 patent. All claims, counterclaims, affirmative defenses, and demands regarding the ’208 patent are dismissed with prejudice, and, upon entry, this consent judgment will be a final judgment of non-infringement in accordance with Fed R. Civ. P. 54(b). No claims, counterclaims, affirmative defenses, or demands other than those with respect to the ’208 patent shall be affected by this consent judgment. Each party shall bear its own costs and expenses, including attorneys’ fees.
Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 22-0296 (D. Del.)	Ozempic® (semaglutide injection)	8,129,343	Sun stipulates that the Sun ANDA infringes the ’343 patent, except as to any asserted claim found invalid and/or unenforceable. Novo agrees that if it withdraws its assertion of any of the asserted claims of the ’343 patent against Sun, then this stipulation of infringement will not apply to any of the withdrawn claims. Nothing limits Sun’s rights under 35 U.S.C. § 271(e)(1) or Novo’s rights under 35 U.S.C. § 271(e)(4). Each party to bear its own costs, expenses, and attorneys’ fees.
Salix Pharms., Inc. v. Carnegie Pharms., LLC, 24-7531 (D.N.J.)	Colazal® (balsalazide disodium capsules)	7,452,872 7,625,884	All claims, defenses, and counterclaims are dismissed with prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses.
Galderma Labs., L.P. v. Taro Pharms. Inc., 24-0333 (D.N.J.)	Aklief® (trifarotene cream)	9,084,778 9,498,465	Patents-in-suit are valid and enforceable with respect to Taro’s ANDA product. All claims, affirmative defenses, and counterclaims are dismissed with prejudice. Nothing shall prevent Taro from challenging the patents-in-suit in proceedings involving products other than the Taro ANDA product. Except as authorized by Galderma, Taro is enjoined from infringing the patents-in-suit and from challenging their validity or enforceability. All protective orders in this action remain in full furce. Parties waive right to appeal. Each party to bear its own costs, expenses, and attorneys’ fees. Nothing shall prohibit Taro from maintaining its Paragraph IV Certification notice to the patents-in-suit or prohibit FDA from granting Taro’s ANDA product final approval. The 30-month stay is terminated.
Novartis Pharms. Corp. v. Torrent Pharma Inc., 19-1979, 21-1330, 21-1794 (D. Del.)	Entresto® (sacubitril / valsartan tablets)	8,101,659 8,796,331 8,877,938 9,388,134 11,058,667 11,096,918	Sealed.
Acerta Pharma B.V. v. MSN Pharms. Inc., 22-0163 (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 suthorized by the settlement agreement, MSN is enjoined from infringing the patents-in-suit. The 30-month stay is terminated. Nothing prohibits MSN from maintaining a Paragraph IV certification with respect to MSN’s ANDA products. All claims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees.
Actelion Pharms. US, Inc. v. Alembic Pharms. Ltd., 23-0383 (D. Del.)	Uptravi® (selexipag tablets))	7,205,302	Alembic agrees the ’302 patent is valid and enforceable. Unless otherwise authorized by Plaintiffs, Alembic is enjoined from infringing the ’302 patent until the later of October 31, 2026 or the last day of pediatric exclusivity associated with the ’302 patent. Complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
Par Pharm., Inc. v. Long Grove Pharms., LLC, 23-1412 (D. Del.)	Vasostrict® (vasopressin injection)	9,993,520 11,207,372	All claims and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Upsher-Smith Labs., LLC v. AMTA Labs Ltd., 24-0058 (D. Del.)	Qudexy® XR (topiramate extended-release capsules)	10,363,224	Parties’ claims and counterclaims are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Chiesi Farmaceutici S.p.A. v. Teva Pharms., Inc., 24-0441 (D. Del.)	Mycapssa® (octreotide capsules)	8,329,198 8,535,695 9,265,812 9,566,246 10,238,709 10,695,397 11,052,126 11,141,457 11,338,011 11,510,963 11,857,595 11,890,316	Until expiration of the patents-in-suit, Teva is enjoined from infringing the patents-in-suit, except as specifically authorized by Chiesi. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or atttorneys’ fees to any party. Nothing prohibits Teva from maintaining a Paragraph IV certification with respect to the patents-in-suit. Nothing restricts FDA from approvaing Teva’s ANDA.
Merck Sharp & Dohme LLC v. Azurity Pharms., Inc., 24-0545 (D. Del.)	Januvia® (sitagliptin phosphate oral solution)	7,326,708	All claims and counterclaims are dismissed without prejudice, and further, that all defenses to such claims and counterclaims are hereby dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Upsher-Smith Labs., LLC v. Xiamen LP Pharm. Co., Ltd., 23-0199 (D. Del.)	Qudexy® XR (topiramate extended-release capsules)	8,889,190 9,101,545 9,555,005 10,363,224	The parties’ claims and counterclaims are dismissed without prejudice and without costs, disbursements, or atorneys’ fees to any party.
Novo Nordisk Inc. v. Rio Biopharms., Inc., 24-0330 (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 Rio from maintaining a Paragraph IV certification to the patents-at-issue in the Rio ANDA for the purposes of receiving or maintaining final approval of the Rio ANDA, or prevents FDA from granting final approval of the Rio ANDA. Each party will bear its own attorneys’ fees and costs.
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. Granules India Ltd., 24-0081 (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.
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. Sun Pharm. Indus., Inc., 23-0295 (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.
Catalyst Pharms., Inc. v. Inventia Healthcare Ltd., 23-22461 (D.N.J.)	Firdapse® (amifampridine tablets)	10,626,088 10,793,893 11,060,128 11,268,128 11,274,331 11,274,332	Unless specifically authorized by Catalyst and SERB or by 35 U.S.C. § 271(e)(1), Inventia is enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall prohibit FDA from granting final approval to Inventia’s ANDA.
Actelion Pharms. US, Inc. v. Cipla Ltd., 23-0389 (D. Del.)	Uptravi® (selexipag tablets))	8,791,122 9,284,280	Cipla agrees the patents-in-suit are valid and enforceable. Unless otherwise authorized by Plaintiffs, Cipla is enjoined from infringing the patents-in-suit until the expiration of the patents-in-suit or the last day of pediatric exclusivity associated with the patents-in-suit. Parties waive righ to appeal. Complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
UCB, Inc. v. Mylan Technologies Inc., 22-0216 (D. Vt.)	Neupro® (rotigotine transdermal system)	8,246,979 8,246,980 10,130,589 10,350,174	Except pursuant to the settlement agreement or prior license agreements, Mylan is enjoined from infringing the patents-in-suit until the expiration of such patents. Nothing prevents FDA from granting final approval to Mylan’s ANDA. The consent judgment may not be asserted by the parties with respect to any cause of action regarding any product other than the Mylan Product and shall not have preclusive effect with respect to any cause of action regarding any product other than the Mylan Product. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Aragon Pharms., Inc. v. Sandoz Inc., 22-3044 (D.N.J.)	Erleada® (apalutamide tablets)	8,445,507 8,802,689 9,388,159 9,987,261	Sandoz admits that the claims of the patents-in-suit are not invalid and not unenforceable, and that the claims of the patents-in-suit would be infringed by the unlicensed manufacture and sale of the Sandoz ANDA product. Sandoz is enjoined from infringing the patents-in-suit until the expiration of the patents-in-suit, including exclisivities and adjustments, other than asauthorized by Plaintiffs. Sandoz may contest infringement, validity, and/or enforceability of the patents-in-suit concerning any product not the Sandoz ANDA. All affirmative defenses, claims, and counterlcaims are dismissed without prejudice. Parties shall bear their own costs and fees, including attorneys’ fees. Parties waive right to appeal. Nothing prohibits Sandoz from maintian its PIV Certification to the patents-in-suit or prohibits FDA from approval Sandoz’s ANDA. The 30-month stay is termianted.
Beigene USA, Inc. v. Sandoz Inc., 24-1972 (D.N.J.)	Brukinsa® (zanubrutinib capsules)	10,927,117 11,591,340	Parties stipulate to dismiss all claims and counterclaims without prejudice. Each party to bear its own costs, expenses, and attorneys’ fees.
Merck Sharp & Dohme LLC v. Hetero USA Inc., 23-22954 (D.N.J.)	Isentress HD® (raltegravir tablets)	7,169,780 7,754,731 8,771,733 9,649,311 10,772,888	The Hetero product infringes the patents-in-suit. Unless authorized pursuant to the settlement agreement, Hetero, is enjoined from infringing the patents-in-suit. The consent judgment has no effect outside of the US. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Axsome Malta Ltd. v. Sandoz Inc., 24-0860 (D.N.J.)	Sunosi® (solriamfetol tablets)	11,771,666 11,771,667 11,779,554 11,793,776 11,839,598 11,839,599 11,850,226 11,850,227 11,850,228	Having withdrawn its ANDA, Sandoz, along with Plaintiffs stipulate to dismiss without prejudice all claims, counterclaims, and affirmative defenses without costs or attorneys’ fees.
Pfizer Inc. v. Biocon Ltd., 24-0757 (D. Del.)	Xeljanz® XR (tofacitinib citrate extended-release tablets)	RE41,783	All claims dismissed without prejudice.
Jazz Pharms. Research UK Ltd. v. Apotex Inc., 23-0018, 23-3914, 23-23141, 24-7550 (D.N.J.)	Epidiolex® (cannabidiol oral solution)	9,949,937 9,956,183 9,956,184 9,956,185 9,956,186 10,092,525 10,111,840 10,137,095 10,603,288 10,709,671 10,709,673 10,709,674 10,849,860 10,918,608 10,966,939 11,065,209 11,096,905 11,154,516 11,160,795 11,207,292 11,311,498 11,357,741 11,400,055 11,406,623 11,446,258 11,633,369 11,701,330 11,766,411 11,963,937	Plaintiffs’ and Lupin’s claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to the parties. Jazz’s dismissal of these matters with respect to Lupin shall not result in the dismissal of any claims, defenses, and/or counterclaims with respect to any other defendant.