SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): June 11, 2019
Corcept Therapeutics Incorporated
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction
149 Commonwealth Drive
Menlo Park, CA 94025
(Address of principal executive offices, with zip code)
(Registrants telephone number, including area code)
(Former name or former, address, if changed since last report)
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Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange
on which registered
|Common Stock, $0.001 par value||CORT||The Nasdaq Capital Market|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
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|Item 8.01|| |
On June 11, 2019, Corcept Therapeutics Incorporated (the Company) announced that it has received a Paragraph IV Notice Letter advising that Sun Pharmaceutical Industries Limited (Sun) submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking authorization from the FDA to manufacture, use or sell a generic version of KORLYM® Mifepristone Tablets, 300 mg (Korlym) in the United States.
The Notice Letter contains Paragraph IV certifications against certain of the Companys patents related to Korlym, specifically U.S. Patent Nos. 8,921,348 (exp. 2028); 9,829,495 (exp. 2036); 10,006,924 (exp. 2036); 9,943,526 (exp. 2036); 10,151,763 (exp. 2028); 10,166,242 (exp. 2036); 10,166,243 (exp. 2036); 10,195,214 (exp. 2037) and 10,231,983 (exp. 2038) (collectively, the Korlym Patents), which are listed in the FDAs Approved Drug Products with Therapeutic Equivalence Evaluation (Orange Book).
The Notice Letter alleges that the Korlym Patents will not be infringed by Suns proposed product, are invalid and/or are unenforceable. The Company intends to vigorously defend its intellectual property rights related to Korlym.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|CORCEPT THERAPEUTICS INCORPORATED|
|Name:||G. Charles Robb|
|Title:||Chief Financial Officer and Secretary|
Date: June 11, 2019