Indian drugmaker Dr Reddy’s Labs (DRL) along with Australian biopharma company Alchemia said

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that the US Food and Drug Administration has approved the launch of their generic version of Glaxo’s patented drug containing Fondapar-inux Sodium, used to treat blood clots.

DRL would now manufacture the injectable drug under license using a patented process developed by 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,” said G V Prasad, vice-chairman and chief executive officer of DRL.

“From a commercial perspective, Dr Reddy’s will 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.

“This approval is a major milestone for Alchemia, fondaparinux representing a significant source of potential future income for the company,” added Pete Smith, CEO of Alchemia.

Pharma analysts believe that this may well raise the profit base for the company. “Fonda is an interesting limited period/limited competition opportunity for Dr Reddy’s. For FY12E/FY13E, we estimate revenues of $21milion/51million,” according to Religare analysts.

It also says Dr Reddy’s has paid a milestone income of $1.6 million to Alchemia and is its sole marketing partner for Fonda.

Once the drug is launched, Dr Reddy’s will first recoup around $20 million incurred on development costs.