EKR Therapeutics, Inc., a specialty pharmaceutical company focused on commercializing acute-care hospital products, today announced that the US Patent and Trademark Office has issued two new patents covering methods of treatment and methods of preparation for the Company’s Ready-to-Use (RTU) Cardene® I.V. (nicardipine hydrochloride) Premixed Injection.
“The active ingredient in Cardene is the antihypertensive agent nicardipine hydrochloride”
Previously, EKR was granted patent protection covering pharmaceutical formulations of its RTU Cardene I.V. bags, a specialty product line currently marketed in four different preparations for treating acute hypertension in emergency and critical-care settings. All three patents – formulation, method of treatment, and method of preparation - are effective through 2027 and, collectively, provide broad patent protection against generic or other similar formulations of EKR’s RTU Cardene I.V.
“The active ingredient in Cardene is the antihypertensive agent nicardipine hydrochloride,” said Howard Weisman, EKR’s CEO & President. “We have pursued and have now successfully secured exceptionally strong intellectual property protection to this key antihypertensive in the ready to use dosage form. These two new patents coupled with our previously issued formulation patent create significant barriers to generic entry and will enable EKR to continue to expand its Cardene franchise well into the future.”
EKR noted that it has already filed the previously issued formulation patent for RTU Cardene I.V. with the U.S. Food and Drug Administration (FDA) for publication in the agency’s Orange Book. The now approved method of treatment patent is also eligible for listing in the Orange Book and EKR will immediately proceed with the necessary filing. Listing in the FDA Orange Book provides additional protection under Hatch Waxman relative to EKR’s intellectual property rights and proprietary ownership of RTU Cardene I.V. The Company has also filed for intellectual property protection for RTU Cardene I.V. in other countries.