ANDA Litigation Settlements

Winter 2017

GENERICally Speaking
Case Name Drug Patent No(s). Publicly Available Terms
Amgen v. Hetero USA Inc., 16-0928 (D. Del.) Sensipar® (cinacalcet HCl tablets) 9,375,405 N/A
AstraZeneca AB v. MSN Labs. Private Ltd., 15-3383 (D.N.J.) Daliresp® (roflumilast tablets) 8,536,206
8,604,064
8,618,142
N/A
Allergan, Inc. v. Innopharma, Inc., 15-1504 (E.D. Tex.) Restasis® (cyclosporine ophthalmic emulsion) 8,629,111
8,633,162
8,642,556
8,648,048
8,685,930
9,248,191
InnoPharma will be allowed to market its generic version of Restasis in February 2024 or possibly earlier. InnoPharma may also be allowed to launch an authorized generic version of the drug with Allergan as the supplier in August 2024.
Janssen Pharmaceutica, N.V. v. Mylan Pharms., Inc. 15-0760 (D. Del.) Complera® (emtricitabine, rilpivirine, and tenofovir) 8,841,310
7,125,879
8,101,629
8,080,551
7,399,856
7,563,922
8,101,752
8,618,291
Mylan may enter the market with its generic equivalent at some undisclosed date under a license agreement entered into by the parties.
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