Centaur Pharma Launches New Generic Cardiac Drug Ivabradine Hydrochloride in US
Overview
Centaur Pharmaceuticals, which ranks among India’s few, fully integrated pharmaceutical firms with proficiencies across the pharmaceutical value chain, has launched its generic version of Corlanor (ivabradine hydrochloride) tablets, 5mg and 7.5mg in the United States (US) through its marketing partner Ingenus Pharmaceuticals.
Ivabradine Hydrochloride: Indication
The ANDA ivabradine hydrochloride tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction.
Annual sale: -Corlanor had annual sales of USD 149 million as of MAT May 2024, according to IQVIA data.
ANDA for Ivabradine Hydrochloride
The ANDA for this ivabradine hydrochloride tablets product received 180-day exclusivity according to the Hatch-Waxman Act from the US Food and Drug Administration (FDA), a status that applies to a first-generic applicant.
Centaur has highlighted that this product is a day one launch, entering the market as a generic equivalent to Corlanor tablets.
Centaur Specialities
Centaur specializes across the pharmaceutical value chain including API, formulations, contract research and manufacturing services, clinical research, R&D, regulatory and marketing. Centaur currently has several products in its active development pipeline.
Centaur Pharmaceuticals
Headquartered in Mumbai, Centaur Pharmaceuticals commenced pharmaceutical manufacturing operations in 1978.
It has now evolved into a vertically integrated pharmaceutical company.
Centaur has a strong matrix of capabilities across the pharmaceutical value chain including API, formulations, contract research and manufacturing services, clinical research, R&D, regulatory and marketing.
With 42 percent of its sales accruing from international markets, Centaur exports to 96 countries across five continents.
With world-class infrastructure and key initiatives across people, processes and practices, Centaur is poised to leverage synergies across the pharmaceutical spectrum and provide end-to-end solutions to prestigious pharmaceutical partners.
Centaur has set growth plans which it hopes to achieve by leveraging integration synergies, sharpening international focus, entering into strategic alliances and In-licensing molecules.