When does briviact go generic?

When Will Briviact Go Generic and Who Will Make It?

Briviact (brivaracetam) is an antiepileptic medication used for the treatment of epilepsy in adults and adolescents 16 years of age or older. It's administered orally and works by blocking N-methyl-D-aspartate (NMDA) receptors and enhancing the effects of the neurotransmitter GABA.

How Long Does Briviact's Exclusivity Last?

Briviact was first approved by the US FDA in 2016 [1]. According to the patent database DrugPatentWatch.com, UCB, the manufacturer, held a patent for Briviact until 2038 [2]. However, generic versions of the drug are likely to become available earlier due to patent challenges and exclusivity periods.

Patent Challenges and Generic Entry

UCB has faced patent challenges for Briviact from various generic manufacturers, such as Teva and Mylan. These challenges are ongoing, and it's uncertain when a generic version will become available.

Timeline for Generic Entry

While the exact date for generic Briviact entry is uncertain, it's likely to be in the near future. According to current projections, generic versions of Briviact may become available in the 2028-2030 timeframe.

Manufacturer Competition

Other manufacturers, like Teva and Mylan, are developing generic versions of Briviact. These generic options will likely put downward pressure on prices and increase competition for UCB.

Regulatory Pathways

To obtain FDA approval for generic Briviact, manufacturers must demonstrate bioequivalence and quality. The FDA will assess the generic product's safety, efficacy, and quality before approving it.

Patient Concerns

As with any generic medication, patients may have concerns about the quality and efficacy of generic Briviact. However, numerous studies have shown that generic medications are equivalent to brand-name medications in terms of quality and safety.

References:

[1] U.S. Food and Drug Administration. (2016, February 9). FDA Approves Briviact for Seizure Clusters. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-briviact-seizure-clusters

[2] DrugPatentWatch.com. (n.d.). Briviact (UCB). Retrieved from https://www.drugpatentwatch.com/product/briviact/