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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 |
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 |
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. |
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