Item 8.01. Other Events.
On December 19, 2012, Santarus, Inc. ("Santarus") received a Paragraph IV
Certification Notice from Mylan Pharmaceuticals Inc. ("Mylan") advising of the
submission to the U.S. Food and Drug Administration ("FDA") of an Abbreviated
New Drug Application ("ANDA") for a generic version of Fenoglide ® (fenofibrate)
tablets, 40 mg and 120 mg. Mylan's notice letter alleges invalidity,
unenforceability and/or non-infringement of U.S. Patent Nos. 7,658,944 and
8,124,125, which are listed in the FDA Orange Book for Fenoglide tablets.
Santarus is evaluating its options in response to Mylan's notice letter.
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