Drug companies seek to block generic version of ulcerative colitis therapy

Generics/News | Posted 13/03/2015 post-comment0 Post your comment

The patent holder and manufacturer of Uceris (budesonide), a treatment for ulcerative colitis, have sued generics company Actavis for infringing their drug’s patents. Actavis recently filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Budesonide extended-release tablets, 9 mg.

Patent 2 V13E31

Santarus, a wholly-owned subsidiary of Salix Pharmaceuticals, launched Uceris in February 2013, a month after getting FDA approval. The therapy brings in an estimated US$144 million in annual sales, according to the US Securities and Exchange Commission.

New drug application holder Santarus and patent owner Cosmo wish to bar Actavis from marketing a generic version of their drug until all six of its patents expire – the last one (‘064) does not expire until 2031.

A statement from Actavis says that the lawsuit was filed according to the Hatch-Waxman Act, meaning that FDA approval of Actavis' ANDA might be delayed for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter, whichever happens first.

Actavis believes it may be a ‘first applicant’ to file an ANDA for the generic version of Uceris. If its ANDA is approved, Actavis could be entitled to 180 days of generics market exclusivity. 

FDA released 31 new draft guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients, including Budesonide extended-release tablets, 9 mg, in December 2014 [1].

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1.    GaBI Online - Generics and Biosimilars Initiative. FDA releases 53 new and revised bioequivalence guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 13]. Available from: www.gabionline.net/Guidelines/FDA-releases-53-new-and-revised-bioequivalence-guidelines-for-generics 

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