Actavis confirms generic Rayos patent challenge
Actavis, Inc. has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Prednisone delayed-release tablets, 1 mg, 2 mg and 5 mg.
Actavis’ ANDA products are generic versions of Horizon Pharma’s Rayos, which is approved for use as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation; for the treatment of certain endocrine conditions; and for palliation of certain neoplastic conditions.
Horizon Pharma AG and Jagotec AG filed suit against Actavis on August 26, 2013, in the US District Court for the District of New Jersey seeking to prevent Actavis from commercializing its ANDA products prior to the expiration certain of US patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Based on available information, Actavis believes it may be a “first applicant” to file an ANDA for the generic version of Rayos and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
Actavis Inc. is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.
