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Mylan launches authorized generic Ampyra tablets

Mylan is introducing dalfampridine extended-release tablets, 10 mg, the authorized generic version of Acorda's Ampyra, which is indicated to improve walking in adult patients with multiple sclerosis.

The launch comes after 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: U.S. Patent Nos. 8,663,685, 8,007,826, 8,440,703, and 8,354,437. Acorda's U.S. Patent No. 5,540,938, previously upheld by the District Court, expired on July 30, 2018.

"The launch of dalfampridine extended-release tablets is yet another example of Mylan's continued commitment to providing access for patients living with multiple sclerosis, and adds to our portfolio of products indicated for the disease or its related conditions," Mylan CEO Heather Bresch said, in a press release statement. "Mylan offers 100 products in the area of CNS alone, including 20 of the top CNS products dispensed in the U.S."

Dalfampridine extended-release tablets, 10 mg, had a market value of approximately $553 million for the 12 months ended June 30, according to IQVIA.
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