ANDA Litigation Settlements

Fall 2015

Case Name	Drug	Patent No(s).	Publicly Available Terms
Forest Labs., Inc. v. Amneal Pharms. LLC, 15-0508 (D. Del.)	Namenda XR® (memantine hydrochloride)	5,061,703 8,039,009 8,168,209 8,173,708 8,283,379 8,329,752 8,362,085 8,598,233	Subject to FTC review, plaintiffs will grant Amneal a license to market generic versions of Namenda XR beginning on Jan. 31, 2020, following receipt by Amneal of final approval from the FDA. Alternatively, under certain circumstances, Amneal has an option to launch an authorized generic version of Namenda XR beginning on Jan. 31, 2021.
United Therapeutics Corp. v. Sandoz Inc., 12-1617, 13-0316 (D.N.J.)	Remodulin® (treprostinil sodium injection)	6,765,117 7,999,007	United Therapeutics Corp. grants Sandoz a non-exclusive license to manufacture and sell generic Remodulin starting June 26, 2018, and perhaps sooner under certain circumstances. Both parties drop their respective pending appeals and a separate patent lawsuit over the process for preparing treprostinil sodium. The FTC and U.S. DOJ will review the agreement.

Case Name

Drug

Patent No(s).

Publicly Available Terms

Forest Labs., Inc. v. Amneal Pharms. LLC, 15-0508 (D. Del.)

Namenda XR® (memantine hydrochloride)

5,061,703
8,039,009
8,168,209
8,173,708
8,283,379
8,329,752
8,362,085
8,598,233

Subject to FTC review, plaintiffs will grant Amneal a license to market generic versions of Namenda XR beginning on Jan. 31, 2020, following receipt by Amneal of final approval from the FDA.

Alternatively, under certain circumstances, Amneal has an option to launch an authorized generic version of Namenda XR beginning on Jan. 31, 2021.

United Therapeutics Corp. v. Sandoz Inc., 12-1617, 13-0316 (D.N.J.)

Remodulin® (treprostinil sodium injection)

6,765,117
7,999,007

United Therapeutics Corp. grants Sandoz a non-exclusive license to manufacture and sell generic Remodulin starting June 26, 2018, and perhaps sooner under certain circumstances. Both parties drop their respective pending appeals and a separate patent lawsuit over the process for preparing treprostinil sodium. The FTC and U.S. DOJ will review the agreement.