Santarus 8-K 2011
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 15, 2011
(Exact Name of Registrant as Specified in Its Charter)
(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:
Item 8.01. Other Events
On November 15, 2011, Santarus, Inc. (Santarus) received a Paragraph IV Certification Notice from Zydus Pharmaceuticals USA, Inc. (Zydus) advising of the submission to the U.S. Food and Drug Administration (FDA) of an Abbreviated New Drug Application (ANDA) for the prescription product omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg and 40 mg/1100 mg. Also on November 15, 2011, MSD Consumer Products, Inc., a subsidiary of Merck & Co., Inc. (Merck), received a Paragraph IV Certification Notice from Zydus advising of the submission to the FDA of an ANDA for the over-the-counter (OTC) product omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg.
Zydus notice letters allege that U.S. Patent Nos. 6,645,988; 6,489,346; 6,699,885; and 7,399,772; each of which is listed in the Orange Book for Zegerid® Capsules and Zegerid OTC®, are invalid and/or will not be infringed by Zydus manufacture, use, or sale of the products for which the ANDAs were submitted.
In connection with ongoing litigation relating to Zegerid prescription products, the U.S. District Court for the District of Delaware ruled in April 2010 that these patents were invalid due to obviousness. Santarus filed an appeal of that decision in May 2010, and the appeal is pending.
Santarus entered into an OTC license agreement with Merck in October 2006, granting Merck exclusive rights to develop, manufacture, market and sell Zegerid® brand omeprazole products for the OTC market in the U.S. and Canada.
Santarus and Merck are evaluating their options in response to Zydus notice letters.
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.