TIEFENBACHER PHARMACEUTICALS announces global launch of Rivaroxaban – an anticoagulant medication (blood thinner)

Tiefenbacher Pharmaceuticals, part of Tiefenbacher Group, is pleased to announce the availability of a registration dossier for the generic of Rivaroxaban 2.5 mg, 10 mg, 15 mg and 20 mg film-coated tablets. Generics are therapeutically equivalent to their branded counterparts with a lower price due to losing patent protection. The low cost of generic medications promotes patient affordability and contributes to lower per capita healthcare spending.

Rivaroxaban, an anticoagulant medication (blood thinner), was developed at TIEFENBACHER LABORATORIES, Hyderabad. Commercial production for early markets is conducted outside of Europe. For European markets, the product will be manufactured at TIEFENBACHER GROUP facility on Cyprus. The formulation has successfully passed fifteen global bioequivalence studies and six additional pivotal studies are currently under preparation. The registration dossier is currently approved in several EU markets via DCP and via national applications in CIS countries and in Canada. The product has already been successfully launched in early markets and further markets will follow during the course of this year. The registration dossier is under filing in several additional international markets with a global roll out to follow in more than sixty markets throughout the world. The market exclusivity and basic patent have already expired, while the SPC will expire in September 2023 in Europe.

Disclaimer: Rivaroxaban, which is subject to patent prosecution, is currently not offered or made available in countries where patents are in force.

TIEFENBACHER PHARMACEUTICALS, a part of Tiefenbacher Group, develops and commercializes generic, value added, and innovative pharmaceuticals as well as medical devices worldwide. We provide over 180+ pharmaceutical products across various therapeutic categories in 10+ dosage forms. With our in-house product development and manufacturing, we can address specific therapeutic needs in unique formulations of prescription drugs (Rx) and over-the-counter (OTC) medicines for global markets (including highly potent drugs).  

For more information about our finished dosage forms and healthcare solutions, please contact Tiefenbacher Pharmaceuticals: info@tiefenbacher.com or please visit us on: www.tiefenbacher-pharmaceuticals.com

About Tiefenbacher Group – Pioneering Healthcare since 1963

Tiefenbacher Group is a purpose-driven and 100% family-owned healthcare company providing best-in-class solutions along the entire pharmaceutical value chain. From the initial idea to market access of high-quality medicines around the world: We distribute APIs and develop, produce, and register finished dosage forms (FDFs) including highly potent drugs as well as medical devices. Our purpose is to improve people’s lives by making pharmaceuticals more affordable, more available, and better than ever before.

For further information about TIEFENBACHER GROUP and our solutions for better healthcare and our in-house capabilities to develop and commercialize pharmaceutical products for global markets (including highly potent drugs) please contact us by email at info@tiefenbacher.com or visit us on:  www.tiefenbachergroup.com