Briviact generic availability?

When will a generic version of Briviact be available?

Briviact, a medication used for the treatment of partial-onset seizures, is a brand name owned by UCB. According to DrugPatentWatch.com [1], the patent for Briviact (brivaracetam) is set to expire in 2027 in the United States.

However, as the patent expiration date nears, companies may start challenging the patent, which could lead to generic versions being approved by the FDA.

Can biosimilars enter before patent expiry?

In the United States, the Biologics Price Competition and Innovation Act (BPCIA) provides a pathway for biosimilars, biologically similar versions of branded products. If a company can demonstrate that a biosimilar meets the requirements, it can be approved by the FDA up to 9 months before the original product's patent expires. However, biosimilar applications submitted through this pathway must be made at least 180 days before approval. If no biosimilar applications are submitted, a generic drug manufacturer could potentially receive an approval from the FDA before the end of the patent term.

What is the current regulatory landscape?

As of now, no generic or biosimilar versions of Briviact have been approved by the FDA. UCB has a strong patent portfolio surrounding the product, which could complicate the introduction of generic or biosimilar versions. However, as the patent expiration date nears, the market is likely to become more competitive, with companies vying for a share of the market.

References:

[1] DrugPatentWatch.com - Brivaracetam Patented Products (Accessed 26 May 2026)

Sources:

[1] https://www.drugpatentwatch.com/drugs/brivaracetam