Tris Pharma announced the decision by the US District Court for the District of New Jersey to uphold the validity of various patents relating to QuilliChew ER® (methylphenidate hydrochloride) extended-release chewable tablets, for oral use.
The decision further holds that a generic methylphenidate product proposed by Teva Pharmaceuticals USA, Inc., incorporated in its Abbreviated New Drug Application (ANDA) will infringe the asserted Tris patents. In particular, the court found that "Tris has shown by a preponderance of the evidence that all valid asserted claims … were infringed by Teva's ANDA product". The ruling prevents Teva from launching generic versions of QuilliChew ER until the expiration of Tris's patent portfolio, which provides exclusivity until August 2033.
QuilliChew ER is approved for treatment of ADHD in people 6 years and older.