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Mylan’s Recently Launched Generic Version of Ampyra

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Mylan launches a generic version of Acorda’s Ampyra

On September 21, Mylan (MYL) launched its authorized generic version of Acorda Therapeutics’ (ACOR) Ampyra (dalfampridine), which is used for improvement in walking for adults who have multiple sclerosis. Mylan’s dalfampridine extended-release tablets are available in 10 mg tablets, similar to Acorda’s Ampyra. On September 21, MYL stock rose ~2.2% before closing up ~0.67% over the previous day’s closing price.

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According to IQVIA, dalfampridine extended-release tablets (10 mg) generated sales of $553.0 million in the United States during the 12 months ended June 30. During the first half of 2018, Acorda Therapeutics generated Ampyra sales of $253.0 million. Some of the benefits of the drug are shown in the chart above.

Ampyra’s competition dynamics

Acorda Therapeutics’ (ACOR) Ampyra was approved by the FDA in 2010. However, a number of patents held by the company for Ampyra expired in 2018. In August, Mylan and several other players developing generic Ampyra—including Teva Pharmaceuticals (TEVA) and Hikma Pharmaceuticals (HKMPF)—entered into an agreement with Acorda Therapeutics to hold off their generic launches for several more years under certain circumstances.

On September 10, the Court of Appeals for the Federal Circuit supported the decision of the U.S. District Court for the District of Delaware, which had invalidated four Ampyra patents in March 2017. One of the Ampyra patents upheld by the District Court had expired on July 30.

In the next article, we’ll discuss the recent approval of Mylan’s Humira biosimilar in Europe.

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