ANDA Litigation Settlements

Summer 2016

GENERICally Speaking: A Hatch Waxman Litigation Bulletin
Case Name Drug Patent No(s). Publicly Available Terms

Jazz Pharms. Inc. v. Amneal Pharms. LLC, 13-0391 (D.N.J.)

Xyrem®
(sodium oxybate oral solution)

6,472,431
6,780,889
7,262,219
7,851,506
7,895,059
8,263,650
8,324,275

Ranbaxy, Sun, and Ohm Labs. stipulate that their respective ANDA products infringe the patents-in-suit. Ranbaxy, Sun and Ohm agree not to manufacture or to sell the generic drug during the life of the patents. The parties entered into a May 9 licensing agreement.

AstraZeneca Pharms. LP v. Teva Pharms. USA Inc., 14-1478 (D. Del.) Teva Pharms. USA Inc. v. AstraZeneca Pharms. LP, 15-0050 (D. Del.)

Byetta®
(exenatide)

6,858,576
6,872,700
6,956,026
7,297,761
6,902,744
7,521,423
7,741,269

Teva agrees not to market its generic product until October 15, 2017, or earlier if authorized by AstraZeneca.

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