Item 8.01. Other Events
Santarus, Inc. ("Santarus") was notified by Depomed, Inc. ("Depomed") that on November 9, 2009 Depomed received a Paragraph IV Certification Notice in accordance with 21 U.S.C. § 355(j)(5)(B) from Lupin Limited ("Lupin") advising Depomed 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. Santarus promotes GLUMETZA prescription products in the U.S., under the terms of an exclusive promotion agreement that Santarus entered into with Depomed in July 2008. Santarus began its promotion of the GLUMETZA products in October 2008.
Lupin's certification notice sets forth allegations that the 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.
Santarus has been informed by Depomed that it is evaluating the Paragraph IV Certification Notice received from Lupin. 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 Depomed, whichever is earlier.

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