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ANDA Litigation Settlements

Case Name Drug Patent No(s). Publicly Available Terms
Sumitomo Dainippon Pharma Co. Ltd. v. MSN Labs. Private Ltd., 17-1010 (D.N.J.) Latuda® (lurasidone HCl tablets) 5,532,372 MSN Labs. would amend its ANDA to include a Paragraph III certification notice.
AstraZeneca AB v. Mylan Pharms. Inc., 17-1778 (Fed. Cir.) Omidria® (phenylephrine / ketorolac for injection) 8,173,707
8,586,633
9,066,856
9,278,101
9,399,040
9,486,406
9,855,246
Sandoz would amend its ANDA to include a Paragraph III certification notice and not seek approval until the last of of Omeros’ seven patents expire in July 2033.
Salix Pharms. Ltd. v. Actavis Labs. FL Inc., 16-0188 (D. Del.) Xifaxan® (rifaximin tablets) 6,861,053
7,045,620
7,452,857
7,605,240
7,612,199
7,718,608
7,902,206
7,906,542
7,915,275
7,935,799
8,158,644
8,158,781
8,193,196
8,309,569
8,518,949
8,642,573
8,741,904
8,829,017
8,835,452
8,853,231
8,946,252
8,969,398
Actavis will have the ability in January 2028 to either market a royalty-free generic version of Xifaxan, should the FDA approve its ANDA, or to sell authorized generic versions of the drug, with the tablets supplied by Salix. Should Actavis opt for the authorized generic version of the drug, the volume will be dependent on “manufacturing and supply quantities” until the related patents expire at the end of 2029. Under this option, Bausch Health will also receive an unspecified percentage of Actavis’ sales of the drug.

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