Mylan Launches Authorized Generic of Ampyra® Tablets

Mylan's Dalfampridine Extended-Release Tablets, 10 mg, are indicated for patients with multiple sclerosis.


HERTFORDSHIRE, England and PITTSBURGH /PRNewswire/ -- 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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Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time.