Aurobindo gains tentative US FDA approval for generic Vimpat

21 March 2015

Indian drugmaker Aurobindo Pharma (BSE: 524804) has received tentative approval from the US Food and Drug Administration for generic lacosamide tablets 50mg, 100mg, 150mg and 200mg. Notwithstanding the news, the firm’s shares closed 5.55% lower at 1,157.85 rupees on Friday.

Lacosamide is the active ingredient of Belgian drugmaker UCB’s (Euronext Brussels: UCB) Vimpat and is used in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older with a market size of around $593 Million for the 12 months ending January 2015, according to IMS figures quoted by Aurobindo.

ANDA subject of litigation

The company’s Abbreviated New Drug Application contains a Paragraph IV certification and is currently under litigation in the US District Court for the District of Delaware [UCB Inc, UCB Pharma GMBH Research Corporation Technologies Inc and Harris FRC Corporation v Aurobindo Pharma Ltd and Aurobindo Pharma USA Inc, Civil Action No 1:13-cv-01210-UNA].

Aurobindo (including Aurolife) now has a total of 193 ANDA approvals (165 final approvals and 28 tentative approvals) from USFDA. -

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