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8 December 2015Generics

Sandoz accused of infringing 11 AndroGel patents

Unimed Pharmaceuticals, a subsidiary of life sciences company AbbVie, has slammed generics maker Sandoz with a lawsuit alleging infringement of 11 of its patents.

The 11 pate nts cover Unimed’s AndroGel (testosterone gel) product, which is used to treat a deficiency of endogenous testosterone in men.

Unimed sued Sandoz following Sandoz’s submission of an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) to market a bioequivalent version of AndroGel.

Sandoz informed Unimed of its ANDA on October 20. It further argued that Unimed’s patents covering the product are invalid.

Unimed filed the lawsuit on Thursday, December 3, at the US District Court for the District of Delaware.

Unimed alleges that Sandoz’s infringement of each patent is “wilful” and that the case is “exceptional”.

“The submission of the ANDA to the FDA constitutes infringement by Sandoz of the patents-in-suit ... [and] any commercial manufacture, use, sale, offer for sale, or importation of Sandoz’s generic AndroGel would infringe the patents-in-suit,” Unimed said.

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