U.S. District Court upholds validity of Tris Pharma’s Quillivant XR patents

Tris Pharma, a New Jersey-based specialty pharmaceutical company announced the decision by the U.S. District Court for the District of Delaware to uphold the validity of various patents relating to Quillivant XR (methylphenidate HCl).

The decision further holds that a generic methylphenidate product proposed by Actavis, incorporated in its ANDA will infringe the asserted Tris patents. In particular, the Court found that "all the asserted claims of the asserted patents before me on remand are not invalid and that defendants directly infringe, contributorily infringe, and induce the infringement of each of the asserted claims." 

The ruling prevents Activis from launching generic versions of Quillivant XR until the expiration of the patent portfolio providing exclusivity until February 2031.

"This is a huge win for Tris and provides for long exclusive life for a key portfolio product. We welcome this decision upholding the validity of the Quillivant XR patents, as it reflects the innovative nature of our LiquiXR technology which was used to develop Quillivant XR and our other branded ADHD medications," said Ketan Mehta, founder and CEO of Tris Pharma.  "Validation of our intellectual property permits Tris to continue investing in innovation to develop novel treatments that improve patients' lives."