(By Balaseshan) Cadence Pharmaceuticals Inc. (NASDAQ: CADX) said it has agreed to resolve pending Ofirmev (acetaminophen) injection patent litigation with Perrigo Co. (NASDAQ: PRGO).
Cadence has entered into settlement and license agreements with Perrigo and its subsidiary, Paddock Laboratories LLC,. The settlement agreement includes a stipulation by the parties requesting dismissal with prejudice of the lawsuit filed by Cadence in the U.S. District Court for the District of Delaware.
The lawsuit relates to the Abbreviated New Drug Application, or ANDA, filed by Paddock with the U.S. Food and Drug Administration for a generic version of Ofirmev (acetaminophen) injection. Litigation remains ongoing against Exela Pharma Sciences LLC, Exela PharmaSci Inc. and Exela Holdings Inc.
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Under the license agreement, Perrigo has been granted the exclusive right of first refusal to negotiate an agreement with Cadence to market an authorized generic version of Ofirmev (i.e., a generic version marketed under Cadence's New Drug Application) in the U.S., in the event that Cadence elects to launch an authorized generic version of the product.
Additionally, Cadence has granted Perrigo the non-exclusive right to market a generic intravenous acetaminophen product in the U.S. under Perrigo's ANDA, after December 6, 2020, or earlier under certain circumstances.
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Currently, Cadence has listed two Orange Book patents covering OFIRMEV, the last of which, U.S. Patent No. 6,992,218, will expire on June 6, 2021, or December 6, 2021, if pediatric exclusivity is granted.
The license agreement also provides that, if the parties enter into an agreement for Perrigo to market an authorized generic version of OFIRMEV, during the license period, Perrigo would purchase the product exclusively from Cadence.
Cadence would receive product costs plus an administrative fee, as well as a royalty payment based on the net profits achieved by Perrigo from the sale of the authorized generic product. Other details of the settlement are confidential, and the agreements are subject to submission to the Federal Trade Commission and the U.S. Department of Justice.
The settlement and license agreements will become effective upon the entry by the U.S. District Court for the District of Delaware of an order dismissing with prejudice the litigation with respect to Perrigo.
PRGO closed Tuesday's regular session down 0.37% at $102.20, while CADX ended up 0.53% at $3.77.