Ultragenyx Pharmaceutical Inc. Settles DOJOLVI Suit; Generic Launch 2033

What Happened
Ultragenyx Pharmaceutical Inc. (with Baylor Research Institute) announced on an 8‑K that it entered a settlement with Esjay Pharma Private Limited and Esjay Pharma LLC on August 7, 2026, resolving patent litigation over DOJOLVI® (triheptanoin) oral liquid. The suit arose after Esjay submitted an Abbreviated New Drug Application (ANDA) seeking approval to market a generic DOJOLVI in the U.S. Under the agreement, Ultragenyx will grant Esjay a non‑exclusive, royalty‑free license to market its generic DOJOLVI beginning January 1, 2033; that start date would shift to July 1, 2033 if DOJOLVI is granted pediatric exclusivity. The settlement will be submitted to the U.S. Federal Trade Commission and Department of Justice for review. Related litigation against other ANDA filers remains pending in the U.S. District Court for the District of New Jersey.

Key Details

• Settlement executed: August 7, 2026; 8‑K filed August 11, 2026.
• License terms: non‑exclusive, royalty‑free marketing by Esjay starting Jan 1, 2033 (or July 1, 2033 if pediatric exclusivity is awarded).
• Origin: litigation followed Esjay’s ANDA seeking generic approval for DOJOLVI.
• Administrative review: agreement will be submitted to the U.S. FTC and DOJ; other DOJOLVI-related ANDA suits remain pending.

Why It Matters
This settlement sets a clear potential timeline for the first permitted generic version of DOJOLVI from Esjay, which could affect Ultragenyx’s market exclusivity and DOJOLVI revenue beginning in 2033 (or later if pediatric exclusivity applies). The license is non‑exclusive and royalty‑free, meaning Esjay would not pay royalties to Ultragenyx under this agreement. However, the company still has pending litigation against other ANDA filers, and the settlement is subject to regulatory review, so the ultimate competitive and financial impact depends on those outcomes and any future settlements or court decisions.