Generics
Mylan unveils authorised generic Ampyra Tablets for treating multiple sclerosis
24 September 2018 -

Pharmaceutical company Mylan NV (NASDAQ:MYL) reported on Friday the availability of Dalfampridine Extended-Release Tablets in 10 mg to improve walking in adult patients with multiple sclerosis in the US.

The Dalfampridine Extended-Release Tablets in 10 mg is the authorised generic version of Acorda's Ampyra, which is indicated to improve walking in adult patients with multiple sclerosis.

In conjunction, the launch follows the United States Court of Appeals for the Federal Circuit upheld the United States District Court for the District of Delaware's decision to invalidate four Ampyra patents: US Patent Nos. 8,663,685, 8,007,826, 8,440,703 and 8,354,437. The US Patent No. 5,540,938, previously upheld by the District Court, expired on 30 July 2018.

According to IQVIA, the US sales for Dalfampridine Extended-Release Tablets in 10 mg were approximately USD553m for the 12 months ending 30 June 2018.

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