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.
The product 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.

For further information please contact: info@aet.eu

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