Horizon Pharma in settlement agreement with Lupin

On June 27, a subsidiary of Horizon Pharma entered into a Settlement and License Agreement with Lupin and Lupin Pharmaceuticals relating to RAVICTI Oral Liquid, 1.1 gm/mL. Specifically, the Settlement Agreement pertains to on-going patent infringement litigation against Lupin in the U.S. District Court for the District of New Jersey, petitions for Inter Partes Review with the Patent Trial and Appeal Board with respect to certain U.S. patents covering RAVICTI and an appeal to the Court of Appeals for the Federal Circuit of a prior finding of the Patent Trial and Appeal Board. In the Litigation, the Horizon Subsidiary has alleged that a generic version of RAVICTI, for which Lupin is seeking approval to market in the United States pursuant to an Abbreviated New Drug Application, infringes certain U.S. patents that are owned by the Horizon Subsidiary. The parties have agreed to file stipulations of dismissal with the court regarding the Litigation and a joint request for termination in the IPRs. Lupin has further agreed to withdraw from the Appeal. The Settlement Agreement also provides for a full settlement and release by each party of all claims that relate to Lupin’s generic version of RAVICTI or the Litigation, the IPRs or the Appeal.Under the Settlement Agreement, the Horizon Subsidiary granted Lupin a non-exclusive, perpetual, royalty-free license to manufacture and commercialize Lupin’s generic version of RAVICTI Oral Liquid in the United States after the License Effective Date and to take steps necessary to develop inventory of, and prepare to commercialize, Lupin’s generic version of RAVICTI during certain limited periods prior to the License Effective Date.Under the Settlement Agreement, the License Effective Date is July 1, 2026; however, Lupin may be able to enter the market earlier in certain circumstances.

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