DepoMed Inc. (DEPO) said that it has received a Paragraph IV certification notice from Lupin Ltd. advising Depomed of the filing of an Abbreviated New Drug Application with the FDA for a generic version of Glumetza, 500 mg and 1000 mg strengths.
Lupin's certification notice alleges that Depomed's patents 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.
Depomed said it is evaluating the Paragraph IV certification and continues to have full confidence in the intellectual property protecting Glumetza.
Depomed has 45 days 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.
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