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ANDA Litigation Settlements

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
6,488,962
6,635,280
3,723,340
7,438,927
7,731,989
8,192,756
8,252,332
8,333,992

Incepta Pharms.
Ltd and Zydus Pharms. USA Inc. may begin selling generic product on Jan. 1, 2024, or earlier under certain conditions.

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.
Alternatively, Mylan will be permitted to launch an authorized generic version of Actavis' product beginning on October 1, 2015.

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.
Actavis 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.
Actavis receives a royalty-bearing license under Pfizer's patent to sell its ANDA product in 50-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
7,566,445
6,446,627
8,132,712

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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