TIEFENBACHER PHARMACEUTICALS: Launch generic version of Teriflunomide, Multiple Sclerosis (MS)

Tiefenbacher Pharmaceuticals has successfully developed a global dossier for a generic version of Teriflunomide 7 mg and 14 mgfilm-coated tablets. Generics are therapeutically equivalent to their branded counterparts with a lower price due to losing patent protection. Teriflunomide is an important part of the therapy of Multiple Sclerosis (MS) and the global roll-out of the product in more than 40 countries will make this therapy more affordable and better available for the over 2,8 million patients worldwide.

The product was developed and is commercially produced at our Indian manufacturing site TIEFENBACHER LABORATORIES in Hyderabad and at Combino Pharm Ltd. The formulation has successfully passed four bioequivalence studies against reference products from three different markets. The product is already approved in Australia, Canada, New Zealand, and the US – all with strict US Food and Drug Administration (FDA) standards. Additional filings in Europe, South America and South Africa are under preparation and will take place this year in line with data exclusivity expiry.
Disclaimer: Teriflunomide, which is subject to patent prosecution, is currently not offered or made available in countries where patents are in force.