Ready-to-use CARDENE® I.V. Premixed Injection is indicated for the short-term treatment of hypertension and is the only available FDA-approved premixed formulation of nicardipine hydrochloride. Chiesi USA, Inc. owns four patents listed in the FDA’s Orange Book as covering CARDENE® I.V. Premixed Injection—U.S. Patent Nos. 7,612,102, 7,659,291, 8,455,524, and 7,659,290.
On March 23, 2015, District Judge Charlene Honeywell from the U.S. Middle District of Florida in Tampa issued a favorable claim construction ruling for FLH client Shire Pharmaceuticals in one of the Lialda® Hatch-Waxman cases against defendant Mylan Pharmaceuticals.