Corcept Therapeutics (CORT) Settles Patent Litigation with Hikma Pharmaceuticals

Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, today announced that it has entered into an agreement with Hikma Pharmaceuticals USA Inc. ("Hikma") resolving patent litigation related to Korlym®, Corcept’s medication for the treatment of patients with Cushing’s syndrome. The litigation has been pending in the United States District Court for the District of New Jersey since 2021, shortly after Hikma notified Corcept that it had submitted an Abbreviated New Drug Application (ANDA) to the United States Food and Drug Administration (FDA) seeking approval to market a generic version of Korlym.

In connection with the settlement, Corcept has granted Hikma the right to sell a generic version of Korlym in the United States beginning October 1, 2034 or earlier under circumstances customary for settlement agreements of this type.

“It is gratifying to put an end to this litigation,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “Lawsuits are time-consuming diversions from efforts to grow our Korlym business and develop our portfolio of proprietary cortisol modulators, which we have advanced to the clinic as possible treatments for patients with hypercortisolism, solid tumors (including ovarian, adrenocortical and prostate cancer), non-alcoholic steatohepatitis (NASH), antipsychotic-induced weight gain and amyotrophic lateral sclerosis (ALS).”

The settlement agreement is subject to entry by the Court of a consent judgment related to the litigation. As required by law, Corcept and Hikma will submit the agreement to the United States Federal Trade Commission (FTC) and the United States Department of Justice (DOJ) for review. Similar patent litigation brought by Corcept against Teva Pharmaceuticals USA, Inc. remains pending.

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