ANDA Litigation Settlements

Fall 2017

GENERICally Speaking: A Hatch Waxman Litigation Bulletin
Case Name Drug Patent No(s). Publicly Available Terms
Vivus Inc. v. Actavis Labs. FL Inc., 14-3786 (D.N.J.) Qsymia® (phentermine / topiramate) 7,056,890
7,553,818
7,659,256
7,674,776
8,580,298
8,580,299
Actavis to start selling its generic product on Dec. 1, 2024, or earlier “under certain circumstances.” Should Actavis begin selling a generic before its 2024 deadline, Vivus will collect royalties.
Eli Lilly and Co. v. Actavis Labs. UT Inc., 16-1119 (E.D. Va.) Cialis® (tadalafil tablets) 6,943,166 Eli Lilly retains exclusivity over Cialis market until at least Sept. 27, 2018. Eli Lilly and generic defendants entered into a royalty-bearing license agreement.  
Purdue Pharma L.P. v. Mylan Pharms. Inc., 15-1155 (D. Del.) OxyContin® (oxycodone HCl extended-release tablets) 9,073,933 N/A
Amgen v. Apotex Inc., 16-0926 (D. Del.) Sensipar® (cinacalcet tablets) 9,375,405 N/A
Amgen Inc. v. Micro Labs Ltd., 16-0854 (D. Del.) Sensipar® (cinacalcet tablets) 9,375,405 N/A
AstraZeneca Pharms. LP v. Amneal Pharms. LLC, 15-1139 (D. Del.) Byetta® (exenatide for injection) 6,872,700
6,902,744
N/A
AstraZeneca AB v. Torrent Pharma Inc., 15-3375 (D.N.J.) Daliresp® (roflumilast tablets) 5,712,298
8,536,206
8,604,064
8,618,142
N/A

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