MENLO PARK, CA - Depomed Inc. announced in a press release that it has received a Paragraph IV certification notice from Lupin Limited advising Depomed of the filing of an Abbreviated New Drug Application (ANDA) with the 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.
US Patent No. 6,340,475 will expire in 2016, US Patent No. 6,488,962 will expire in 2020, US Patent No. 6,635,280 will expire in 2016 and US Patent No. 6,723,340 will expire in 2021.
Depomed is evaluating the Paragraph IV certification and continues to have full confidence in the Intellectual Property protecting GLUMETZA.
Depomed has 45 days from the receipt of the Paragraph IV certification to commence a patent infringement lawsuit against Lupin that would automatically stay, or bar, the FDA from approving Lupin’s ANDA for 30 months or until a district court decision that is adverse to the company, whichever is earlier.
