Depomed Receives Certification Notice (NASDAQ:DEPO)
Depomed, Inc (NASDAQ:DEPO) announced that they have received a Paragraph IV certification notice from Lupin Limited advising Depomed of the filing of an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration for a generic version of GLUMETZA (metformin hydrochloride extended release tablet) of 500 mg and 1000 mg strengths. Currently Depomed is evaluating the Paragraph IV certification notice and continues to have full confidence in the intellectual property protecting GLUMETZA. The Company is a specialty pharmaceutical company that formulates its products and product candidates with its approved Acuform drug delivery technology which is designed to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract.
At the moment, Depomed already has 2 product candidates in Phase 3 clinical development and two products already approved on the market while there are still many products in early stages which are in the pipeline. 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.
Depomed now 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.
