Benzinga | Jul 15, 2020 05:07PM EDT

Intercept Pharma 8-K Shows Co. Received Paragraph IV Certification Notice From Apotex Indicated Apotex Submitted To FDA Abbreviated New Drug Application Seeking Approval To Manufacture, Sell Generic Version Of Co.'s Ocaliva

On July 13, 2020, Intercept Pharmaceuticals, Inc. (the "Company") received a paragraph IV certification notice (the "PIV Notice") from Apotex Inc. ("Apotex") indicating that Apotex has submitted to the U.S. Food and Drug Administration an Abbreviated New Drug Application ("ANDA") seeking approval to manufacture and sell a generic version of the Company's 5 mg and 10 mg dosage strengths of Ocaliva(r) (obeticholic acid) for primary biliary cholangitis prior to the expiration of the Company's U.S. Patents Nos. 9,238,673, 10,047,117, 10,052,337, and 10,174,073 (collectively, the "Challenged Patents"), which are listed for Ocaliva in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (referred to as the "Orange Book"). The PIV Notice alleges that the Challenged Patents, which expire between June 2033 and April 2036, are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic products described in Apotex's ANDA. Apotex did not make a paragraph IV certification against the Company's U.S. Patents Nos. 7,138,390, 8,058,267 or 8,377,916, which are also listed for Ocaliva in the Orange Book. The Company may receive additional paragraph IV certification notices in the future from ANDA filers seeking approval of a generic version of Ocaliva.