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| Item 8.01. | Other Events. |
On February 3, 2021, Corcept Therapeutics Incorporated (the “Company”) announced that it has received a Paragraph IV Notice Letter advising that Hikma Pharmaceuticals USA Inc. (“Hikma”) 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 Company’s 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); 10,231,983 (exp. 2038); 10,314,850 (exp. 2038); 10,495,650 (exp. 2036); 10,500,216 (exp. 2033); 10,660,904 (exp. 2036); 10,780,097 (exp. 2038); 10,842,800 (exp. 2037); and 10,842,801 (exp. 2032) (collectively, the “Korlym Patents”), which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluation (“Orange Book”).
The Notice Letter alleges that the Korlym Patents will not be infringed by Hikma’s proposed product, are invalid and/or are unenforceable. The Company intends to vigorously defend its intellectual property rights related to Korlym.
SIGNATURE
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 | ||||||
| Date: February 3, 2021 | By: | /s/ Charles Robb | ||||
| Name: Charles Robb | ||||||
| Title: Chief Financial Officer and Secretary | ||||||