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| DEPO > SEC Filings for DEPO > Form 8-K on 10-Nov-2009 | All Recent SEC Filings |
10-Nov-2009
Other Events, Financial Statements and Exhibits
On November 9, 2009, Depomed, Inc. (the "Company") received a Paragraph IV Certification Notice in accordance with 21 U.S.C. § 355(j)(5)(B) from Lupin Limited ("Lupin") advising the Company of the filing of an Abbreviated New Drug Application ("ANDA") with the U.S. Food and Drug Administration (the "FDA") for a generic version of GLUMETZAŽ (metformin hydrochloride extended release tablets), 500 mg and 1000 mg.
Lupin's certification notice sets forth allegations that U.S. Patent Nos. 6,340,475; 6,488,962; 6,635,280; and 6,723,340; each of which is listed in the Patent and Exclusivity Information Addendum of the FDA's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the "Orange Book"), are invalid and/or will not be infringed by Lupin's commercial manufacture, use or sale of the drug products described in Lupin's ANDA.
U.S. Patent No. 6,340,475 will expire in 2016, U.S. Patent No. 6,488,962 will expire in 2020, U.S. Patent No. 6,635,280 will expire in 2016 and U.S. Patent No. 6,723,340 will expire in 2021.
The Company is evaluating the Paragraph IV Certification Notice received from Lupin. The Company 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.
On November 10, 2009, the Company issued a press release announcing its receipt of the Paragraph IV Certification Notice from Lupin. The press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
(d) Exhibits
99.1 Depomed, Inc. Press Release issued on November 10, 2009
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