Dr. Reddy's Receives FDA Approval of Fondaparinux Sodium Injection

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 Laboratories and Alchemia Limited, Brisbane, Australia announced yesterday that Dr. Reddy's has received final approval of Dr. Reddy's ANDA for Fondaparinux Sodium Injection, a bioequivalent generic version of Arixtra?, in the US market on July 11, 2011 by the USFDA.

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.

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 pendin