Dr. Reddy's has received final approval from the United States Food and Drug Administration (USFDA) for Dr. Reddy's ANDA for Fondaparinux Sodium Injection, a bioequivalent generic version of Arixtra, in the US market. This announcement was made by Dr. Reddy's Laboratories and Australia's Alchemia Limited.
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 prefilled color-coded, single-dose syringes with automatic needle safety device. Dr. Reddy's will manufacture fondaparinux under license using a patented process developed by Alchemia.
Commenting on the approval, G.V. Prasad, Vice-Chairman and CEO of Dr. Reddy's said: "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. 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."
Pete Smith, 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."
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.
Arixtra brand had U.S. sales of approximately 340 million dollars (year-on-year growth of 16 percent) for the 12 months ending May 2011.