secwatch.observer — SEC 8-K summary
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Issuer:     Ultragenyx Pharmaceutical Inc. (RARE)
CIK:        0001515673
Form:       8-K
Filed at:   2026-10-19T13:00:13+00:00
Accession:  0001193125-26-424739
Event type: litigation
Sentiment:  positive
Materiality: 0.45
Item codes: 8.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1515673/000119312526424739/0001193125-26-424739-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1515673/000119312526424739/rare-20261019.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-424739

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