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ANDA Litigation Settlements
Summer 2014
![GENERICally Speaking: A Hatch Waxman Litigation Bulletin](/-/media/images/newsletters/generically-speaking-social-graphics/generically-speaking-nwsltr-badge.jpg?la=en&h=160&w=390&la=en&hash=314B8432ED62E0647D7FC4565EC18B79)
Case Name | Drug | Patent No(s). | Publicly Available Terms |
---|---|---|---|
Depomed Inc. v. Actavis Elizabeth LLC, 12-1358 (D.N.J.) Depomed Inc. v. Zydus Pharms USA Inc., 12-2813 (D.N.J.) |
Gralise® (gabapentin tablets) |
6,340,475 |
Incepta Pharms. |
Warner-Chilcott Co., LLC v. Mylan Inc., 11-6844 (D.N.J.) |
Generess® FE (norethindrone / ethinyl estradiol / ferrous fumarate chewable tablets) |
6,667,050 |
Mylan may begin to sell its ANDA product on April 1, 2015, or earlier under certain circumstances, and upon receiving final FDA approval. |
Endo Pharms. Inc. v. Noven Pharms. Inc., 12-0831 (D. Del.) |
Lidoderm® (lidocaine patch) |
5,827,529 |
Settlement agreement grants Noven a nonexclusive license under patent-in-suit to manufacture and sell its ANDA product on undisclosed date. |
G.D. Searle LLC v. Lupin Pharms. Inc., 13-0121 (E.D. Va.) |
Celebrex® (celecoxib) |
RE44,048 |
Teva receives a royalty-bearing license under Pfizer's patent to sell its ANDA product in 50-, 100-, 200-, and 400-milligram capsules in the US beginning in December 2014, or earlier if certain conditions are met. |
Dow Pharm. Sciences, Inc. v. Actavis, Inc., 13-6401 (D.N.J.) |
Acanya® (lincosamide / clindamycin phosphate) |
8,288,434 |
Valeant grants Actavis a license to market its ANDA product beginning July 1, 2018, or possibly earlie runder certain conditions. |
Teva Branded Pharm. Products R&D, Inc. v. Perrigo Pharms. Co., 12-1101 (D. Del.) Teva Branded Pharm. Products R&D, Inc. v. Perrigo Pharms. Co., 13-1441 (D. Del.) |
ProAir® HFA (albuterol sulfate inhalation aerosol) |
7,105,152 |
Perrigo and Catalent receive a license to sell limited units of Perrigo's ANDA product for an initial period beginning Dec. 19, 2016 and lasting until June 2018, when the limits will no longer apply. |
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