ANDA Litigation Settlements

Winter 2016

GENERICally Speaking: A Hatch Waxman Litigation Bulletin
Case Name Drug Patent No(s). Publicly Available Terms
Novartis Pharms. Corp. v. Amneal Pharms. LLC, 15-1025 (D. Del.) Exelon® Patch (rivastigmine transdermal system)
6,316,023
6,335,031
N/A.
AstraZeneca AB v. Micro Labs USA, Inc., 15-3376, 15-7921 (D.N.J.) Daliresp® (roflumilast tablets)
5,712,298
8,431,154
8,604,064
8,618,142
8,536,206
N/A
Warner Chilcott (US), LLC v. Zydus Pharms. (USA), Inc., 16-0323 (E.D. Tex.) Delzicol® (mesalamine delayed-release capsules)
6,649,180
Zydus and Cadila may market a generic version of Delzicol in the US starting on March 1, 2020, pending FDA approval, or earlier under certain circumstances.

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