Ultragenyx Settles DOJOLVI Patent Suit, Licensing Navinta's Generic From January 1, 2033
The license is royalty-free and moves to July 1, 2033 if pediatric exclusivity is granted; other generic-filer suits remain pending.
Ultragenyx and Baylor Research Institute settled their patent litigation with Navinta LLC over the rare-disease drug DOJOLVI, according to an 8-K filed Monday. Navinta gets a license to sell a generic version starting January 1, 2033.
What the 8-K says
The agreement is dated Monday and covers patents on DOJOLVI (triheptanoin) oral liquid. Ultragenyx will grant Navinta a non-exclusive, royalty-free license to market its generic, beginning January 1, 2033.
That date would slide to July 1, 2033 if pediatric exclusivity is granted for DOJOLVI. The license is subject to conditions and exceptions the filing calls customary for agreements of this type.
The suit was filed in the U.S. District Court for the District of New Jersey. It followed Navinta's submission of an Abbreviated New Drug Application, the filing a generic maker sends the FDA to seek approval of a copy of an approved drug.
What it changes
One generic challenger now has a fixed entry date rather than a court fight. Because the license is non-exclusive, the filing does not give Navinta sole rights.
The 8-K says similar suits Ultragenyx brought against other generic filers over DOJOLVI remain pending in the same New Jersey court. Those cases are not resolved by this deal.
In market data, RARE closed at $14.54 at Friday's close, down 4.15% on the session from $15.17. The filing became public Monday at 9:00 a.m. ET, after that close.
What to watch
As required by law, the settlement agreement will be submitted to the Federal Trade Commission and the Justice Department. The remaining New Jersey cases against other generic filers continue.
The filing itself notes that its description of the agreement "does not purport to be complete."
