Paddock Laboratories, LLC. a pharmaceutical company, engages in the manufacture, distribution, and marketing of bioequivalent generic pharmaceuticals. The company also provides contract manufacturing services for over the counter and prescription pharmaceutical products in various dosage forms, such as compounding, ophthalmic/OTICS, topical, indictable, liquids/solids, orals, semi-solids, powders, tablets, capsules, enemas, and suppositories. In addition, it offers primary and secondary packaging services and controlled substances, as well as various support services. The company markets its products through distribution partners to retail pharmacies, as well as to institutional customers in...
3940 Quebec Avenue North
Minneapolis, MN 55427
Founded in 1977
Cadence Pharmaceuticals Inc. Announces Settlement of OFIRMEV(R) (Acetaminophen) Injection Patent Litigation with Perrigo Co
Nov 28 12
Cadence Pharmaceuticals Inc. announced that it has entered into settlement and license agreements with Perrigo Co., and its subsidiary, Paddock Laboratories, LLC, to resolve pending patent litigation involving OFIRMEV(R) (acetaminophen) injection. 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 relating 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(R) (acetaminophen) injection. Litigation remains ongoing against Exela Pharma Sciences, LLC, Exela PharmaSci Inc. and Exela Holdings Inc. 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. 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.