Item 8.01. Other Events

On July 6, 2012, Santarus, Inc. ("Santarus") received a Paragraph IV Certification Notice from Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. (collectively, "Dr. Reddy's") 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.

Dr. Reddy's notice letter alleges 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, are invalid, unenforceable, and/or will not be infringed by Dr. Reddy's manufacture, use, sale, offer to sell in the United States or importation into the United States of the products for which the ANDA was 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 is evaluating its options in response to Dr. Reddy's notice letter.

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