On 27 August 2013, US generics maker Actavis announced that it had filed an abbreviated new drug application (ANDA) with FDA for approval of prednisone delayed-release tablets, 1, 2 and 5 mg, which are generic versions of Horizon Pharma’s Rayos.

On 26 August 2013, Horizon Pharma and Jagotec filed suit against Actavis in the US District Court of New Jersey seeking to prevent Actavis from commercializing its ANDA products prior to the expiration of certain US patents. The action results 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.

The patent on Rayos is not expected to expire in the US until 2024, therefore Actavis could be somewhat jumping the gun here. However, 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.

Rayos is indicated for certain allergic, dermatologic, gastrointestinal, haematologic, 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.

On 29 August 2013, the company also confirmed that all three leading independent proxy advisory firms – Institutional Shareholder Services (ISS), Glass Lewis and Egan-Jones – had recommended that Actavis shareholders vote in favour of adopting the transaction agreement in which Actavis will acquire Warner Chilcott through the formation of a new holding company incorporated in Ireland, expected to be named Actavis.

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