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Perrigo submits patent challenge for generic version of Aveed injection

Perrigo Company has submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for Aveed (testosterone undecanoate) injection.

The company has also notified the owner of the Reference Listed Drug of its filing.

In November, Endo Pharmaceuticals Solutions, Bayer Intellectual Property and Bayer Pharma filed suit against Perrigo in the US District Court for the District of Delaware, alleging patent infringement.

The company said that this action formally starts the process under the Hatch-Waxman Act.

Aveed is a schedule II controlled substance indicated for testosterone replacement therapy in adult males for the conditions associated with a deficiency or absence of endogenous testosterone of primary hypogonadism or hypogonadotropic hypogonadism.

Perrigo chairman, president and CEO Joseph Papa said: "This filing highlights our continued investment in bringing new products to market.

"Perrigo is committed to making quality healthcare more affordable for consumers around the world."

The company develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, nutritional products and active pharmaceutical ingredients (API), and receives royalties from multiple sclerosis drug Tysabri.