Hyderabad: Dr Reddy’s Laboratories and Brisbane-based Alchemia Limited on Wednesday announced that the US Food and Drug Administration gave final approval for the launch of their Fondaparinux Sodium injection, a bioequivalent generic version of Arixtra, in the US market on 11 July.
The approval covers 2.5 mg/0.5 mL, 5.0 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL doses of the drug in pre-filled, color-coded, single-dose syringes with an automatic needle safety device.
Dr Reddy’s will manufacture Fondaparinux under a licence using a patented process developed by Alchemia, DRL said in a statement.
The US patents on Arixtra expired in 2002, the year before the drug was launched in the US.
Alchemia’s process for the synthesis of Fondaparinux is covered by a patent estate with two issued patents and two pending applications in the US.
The Arixtra brand had US sales of approximately $340 million (year-on-year growth of 16%) for the 12 months ending May 2011, according to IMS National Sales Perspectives.
“The Fondaparinux approval demonstrates the strong technical capabilities of the teams at Dr Reddy’s and Alchemia. Given that this is a complex generic molecule which is difficult to manufacture at scale, competition is likely to be limited for the foreseeable future,” Dr Reddy’s vice-chairman and CEO G. V. Prasad said.
“Accordingly, from a commercial perspective, Dr Reddy’s will promptly execute a phased launch that initially plays to our strengths in select wholesale and retail outlets and subsequently enhance share over time in the coming quarters to augment the growing annuity of upsides in our North America generics business,” he said.
Pete Smith, the CEO of Alchemia, said, “This collaboration has succeeded due to the expertise, dedication and close communication between the teams at both companies. This approval is a major milestone for Alchemia, Fondaparinux representing a significant source of potential future income for the company.”