Santarus 8-K 2009
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 30, 2009
(Exact Name of Registrant as Specified in Its Charter)
3721 Valley Centre Drive, Suite 400, San Diego, California 92130
(Address of Principal Executive Offices) (Zip Code)
(Registrants Telephone Number, Including Area Code)
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
TABLE OF CONTENTS
Item 8.01. Other Events
Santarus, Inc. (Santarus) was notified by Depomed, Inc. (Depomed) that Depomed has filed a lawsuit in the United States District Court for the Northern District of California against Lupin Limited and its wholly-owned subsidiary, Lupin Pharmaceuticals, Inc., for infringement of the patents listed in the Orange Book for GLUMETZA® (metformin hydrochloride extended release tablets). 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.
The lawsuit is in response to an Abbreviated New Drug Application (ANDA) filed by Lupin with the U.S. Food and Drug Administration (FDA) regarding Lupins intent to market generic versions of 500mg and 1000mg dosage strengths of GLUMETZA prior to the expiration of the four listed patents (U.S. Patent Nos. 6,340,475; 6,488,962; 6,635,280; and 6,723,340).
Depomed has commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving Lupins ANDA for 30 months or until a district court decision that is adverse to the patents, whichever may occur earlier.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.