Horizon Pharma PLC and Lupin Ltd settled a patent infringement case regarding Horizon's drug Ravicti.
The settlement covers several legal actions, including an ongoing case against Lupin in the U.S. District Court for the District of New Jersey. In the litigation, a unit of Dublin-based Horizon alleged that Lupin's proposed generic version of Ravicti infringes on certain Horizon patents in the U.S.
The settlement also covers petitions for inter partes review with the Patent Trial and Appeal Board and an appeal to the Court of Appeals for the Federal Circuit of a prior finding of the Patent Trial and Appeal Board.
Under the agreement, Horizon granted the Indian drugmaker a nonexclusive, royalty-free license to make and sell a generic version of Ravicti oral liquid in the U.S. after July 1, 2026.
The companies also agreed to submit filings to dismiss the litigation and terminate the inter partes review. Lupin also agreed to withdraw the appeal.
Ravicti, or glycerol phenylbutyrate, is used to manage high levels of ammonia in the blood caused by a condition called a urea cycle disorder.