Mylan N.V issued the following announcement on Sept. 21.
Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced the U.S. launch of 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," said Mylan CEO Heather Bresch. "Mylan offers 100 products in the area of CNS alone, including 20 of the top CNS products dispensed in the U.S."
U.S. sales for Dalfampridine Extended-Release Tablets, 10 mg, were approximately $553 million for the 12 months ending June 30, 2018, according to IQVIA.
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