Dalfampridine Extended-release tablets are indicated to help improve walking in adult patients with multiple sclerosis as demonstrated by an increase in walking speed.
In September 2018, 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 all remaining Ampyra patents.
Hikma was one of the first ANDA applicants to submit an ANDA with a Paragraph IV certification challenging the validity of patents listed for Ampyra tablets, 10 mg, and therefore is eligible for 180 days of generic drug exclusivity.
Of the 10 first-filers, Hikma was one of two generic manufacturers who did not settle with Acorda Therapeutics.
In its 2017 annual report, Acorda Therapeutics reported that US sales of Ampyra were approximately $543 million in 2017, 10% higher than 2016.
Brian Hoffmann, President, Generics Division, said: “We are very pleased to be launching Dalfampridine Extended-release tablets, a life-enhancing medicine for people with multiple sclerosis. This product highlights our ability to successfully litigate patent-protected Paragraph IV products, improving patient access to high-quality, affordable medicines.”
