Ultragenyx settles DOJOLVI patent suit with Navinta; generic entry set for Jan 1, 2033

Ultragenyx Pharmaceutical Inc.

• Settlement among Ultragenyx, Baylor Research Institute and Navinta LLC resolves ANDA patent litigation in the U.S. District Court for the District of New Jersey over DOJOLVI (triheptanoin).
• Navinta receives a non-exclusive, royalty-free license to market its generic DOJOLVI beginning January 1, 2033, extending to July 1, 2033 if pediatric exclusivity is granted.
• Litigation against other ANDA filers seeking generic DOJOLVI approval remains pending in the U.S. District Court for the District of New Jersey.
• No financial terms or payments disclosed; the settlement will be submitted to the U.S. FTC and Department of Justice as required by law.