Line design
GENERICally Speaking: A Hatch Waxman Litigation Bulletin
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.


Related Services

Jump to Page

Robins Kaplan LLP Cookie Preference Center

Your Privacy

When you visit our website, we use cookies on your browser to collect information. The information collected might relate to you, your preferences, or your device, and is mostly used to make the site work as you expect it to and to provide a more personalized web experience. For more information about how we use Cookies, please see our Privacy Policy.

Strictly Necessary Cookies

Always Active

Necessary cookies enable core functionality such as security, network management, and accessibility. These cookies may only be disabled by changing your browser settings, but this may affect how the website functions.

Functional Cookies

Always Active

Some functions of the site require remembering user choices, for example your cookie preference, or keyword search highlighting. These do not store any personal information.

Form Submissions

Always Active

When submitting your data, for example on a contact form or event registration, a cookie might be used to monitor the state of your submission across pages.

Performance Cookies

Performance cookies help us improve our website by collecting and reporting information on its usage. We access and process information from these cookies at an aggregate level.

Powered by Firmseek