Dr Reddy's launches first generic fondaparinux outside USA; debuts Reclast copy in USA

Australian drug developer Alchemia (ASX: ACL) says its commercialization partner, India’s Dr Reddy’s Laboratories (NYSE: RDY) has launched Alchemia’s US Food and Drug Administration-approved generic anti-coagulant fondaparinux in India. This is the first time fondaparinux has been made available outside the USA since the product was launched in July 2011.

Alchemia’s injectable fondaparinux formulation is a bioequivalent generic version of UK pharma giant GlaxoSmithKline’s (LSE) GSK) Arixtra. It will be sold and marketed in India by Dr Reddy’s as a branded generic under the name Fondared to prevent and treat deep vein thrombosis (DVT). Fondared will be available in pre-filled color-coded single dose syringes (2.5mg/0.5mL).

The Arixtra brand achieved Indian sales of about $2.7 million for the year ended December 31, 2012. Alchemia expects to receive 25% of all profits from sales in India, with the same economics from sales to any further territories outside the USA.