Lupin issues notice to Depomed Inc relating to Glumetza patent

Lupin Ltd, a Rs 3,775 crore fifth largest Indian pharma major, has issued a Paragraph IV certification notice to Depomed, Inc regarding filing of an ANDA with the US FDA for a generic version of Glumetza (metformin hydrochloride extended release tablets), 500 mg and 1000 mg strengths. 

Lupin’s certification notice alleges that Depomed’s US Patents (Nos. 6,340,475; 6,488,962; 6,635,280; and 6,723,340) listed in the FDA Orange Book for Glumetza are invalid and/or will not be infringed by Lupin’s commercial manufacture, use or sale of the products described in Lupin’s ANDA.

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