Ultragenyx has settled with one generic filer on DOJOLVI, and the copy waits an extra six months if the company wins paediatric exclusivity
A generic DOJOLVI may go on sale in the United States on 1 January 2033. Unless Ultragenyx wins paediatric exclusivity, in which case it waits until 1 July.
The company told the Securities and Exchange Commission on Tuesday that it and Baylor Research Institute signed a settlement on 7 August with Esjay Pharma Private Limited and Esjay Pharma LLC, ending patent litigation over triheptanoin oral liquid, sold as DOJOLVI. The case began the way most generic drug cases do. Esjay filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval for a copy, and the patent holder sued in the District of New Jersey.
Under the agreement, Ultragenyx grants Esjay a non-exclusive, royalty-free licence from the 2033 date, subject to conditions the filing describes only as customary.
Royalty-free, and what that leaves out
No money changes hands on the face of this document. There is no payment, no milestone and no royalty disclosed, which is worth noting because settlements between a branded manufacturer and a generic applicant are required by law to be filed with the Federal Trade Commission and the Department of Justice. The 8-K says this one will be. It says nothing about what either agency may make of it, and neither does this brief.
The filing also declines to be a full account of itself. The description of the settlement agreement, it says, does not purport to be complete.
One filer, not the product
The clause that changes how the whole thing reads is near the end.
Similar patent litigation against other ANDA filers on DOJOLVI remains pending in the same court. So Tuesday's disclosure fixes a date for one applicant and leaves the field open. How many others there are, and who, the filing does not say.
The six-month step is the tidy part. Paediatric exclusivity is an add-on the FDA grants for studying a drug in children, and the parties wrote it into the licence rather than leaving it to be argued about later. If it is granted, Esjay waits. If it is not, 1 January 2033 stands.
