ANDA Sponsors Swarm On Vimpat Blockbuster As Protection Expires

Amneal, Glenmark, and Sun Pharma Among Firms With ANDA Approvals

UCB’s Vimpat blockbuster has finally fallen to generic competition in the US, after its intellectual property was skewered by ANDA sponsors as part of a failed challenge before the US Supreme Court in 2018 and 2019.

green light
Generic lacosamide has the green light • Source: Alamy

Multiple generic versions of UCB’s €1.13bn ($1.25bn) Vimpat (lacosamide) tablets have been approved by the US Food and Drug Administration in all four strengths after the sole patent shielding the branded treatment of seizures expired.

The end of US reissued patent RE38,551’s term on 17 March has resulted in eight simultaneous ANDA approvals for lacosamide...

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