When does fycompa go generic?

Why Is Fycompa's Patent Still in Effect?

Fycompa (perampanel), an antiepileptic medication developed by Eisai, is protected by U.S. Patent No. 8,663,704, which expires on December 26, 2024 [1]. This patent covers the active ingredient perampanel.

What's Causing Delays in Generic Availability?

Eisai has filed several extension patents to extend the exclusivity of Fycompa. These include U.S. Patent No. 9,514,914, which expires on December 26, 2033 [2], and U.S. Patent No. 11,174,113, issued on April 27, 2022 [3]. These patents cover various aspects of the Fycompa formulation and its manufacturing process.

Will Fycompa Go Generic Before Patent Expiry?

Despite the ongoing patent disputes, generic versions of Fycompa are expected to enter the market after the last patent expires in 2033. Generic companies, however, may attempt to challenge the patent validity or seek approval through the abbreviated new drug application (ANDA) pathway, which allows for generic drug approval before the innovator's patent expires.

References

[1] www.druga-patent-watch.com/perampanel (U.S. Patent No. 8,663,704)

[2] www.druga-patent-watch.com/perampanel (U.S. Patent No. 9,514,914)

[3] www.druga-patent-watch.com/perampanel (U.S. Patent No. 11,174,113)

Sources:

DrugPatentWatch.com (www.drugpatentwatch.com) - patent data and analytics.