Actavis confirms Rayos patent challenge and Warner Chilcott acquisition

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Actavis confirms Rayos patent challenge and Warner Chilcott acquisition

Genéricos/Novedades | Posted 13/09/2013 0 Post your comment

Actavis has filed for US approval for a generic version of the anti-inflammatory or immunosuppressive agent Rayos (prednisone). The company also confirmed its proposed acquisition of Warner Chilcott.

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.

Related articles

Actavis submits ANDAs for two more generics

Actavis makes definitive agreement with Warner Chilcott

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Actavis