U.S. Court of Appeals for the Federal Circuit affirms validity of Tris Pharma’s Quillivant XR patents
Tris Pharma recently announced that the U.S. Court of Appeals for the Federal Circuit issued its decision on July 7, 2022, upholding the validity and infringement of various patents relating to Quillivant XR (methylphenidate HCl).
In December 2020, the U.S. Federal District Court for the District of Delaware issued a favorable decision finding that the Quillivant XR patents were valid and that a generic methylphenidate product proposed by Actavis Laboratories, incorporated in its Abbreviated New Drug Application, would infringe the asserted patents.
[Read more: U.S. District Court upholds validity of Tris Pharma's Quillivant XR patents]
The CAFC decision confirms the lower court finding and prevents Actavis from launching a generic version of Quillivant XR until the expiration of the patent portfolio providing exclusivity in February 2031, Tris Pharma noted.
“We are very pleased with the ruling of the CAFC, which affirms the strength of our patents protecting Quillivant XR,” said Ketan Mehta, founder and CEO of Tris Pharma. “The decision validates Tris’s pioneering research to develop innovative new medicines that improve the lives of patients.”
[Read more: Tris Pharma taps Anthony Amato to lead generics business development]
Quillivant XR is approved for the treatment of ADHD in people 6 years old and older.