Ultragenyx Settles DOJOLVI® Patent Litigation, Allows Generic Entry in 2033

Ultragenyx Pharmaceutical Inc. has entered into a settlement agreement with Esjay Pharma to resolve patent litigation related to its drug, DOJOLVI® (triheptanoin). The litigation stemmed from Esjay's filing of an Abbreviated New Drug Application (ANDA) to market a generic version of DOJOLVI in the United States. The settlement permits a future market entry for Esjay's generic product.

Key Details

• License Terms: Ultragenyx will grant Esjay a non-exclusive, royalty-free license to market its generic version of DOJOLVI.
• Generic Entry Date: Esjay can launch its generic product beginning January 1, 2033. This date may be extended to July 1, 2033, if pediatric exclusivity is granted for DOJOLVI.
• Pending Litigation: The company noted that similar patent litigation against other generic drug filers for DOJOLVI remains ongoing.