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| Edited By: KV Ramana |Source: DNA |Updated: Mar 18, 2018, 05:19 AM IST
Dr Reddy’s Laboratories is gearing up to take its blockbuster generic Arixtra (containing fondaparinux sodium) to Europe.
The company has already filed a marketing authorisation application with the European Medicine Authority seeking approval to do so.
“We had filed an application in the last week of March. We will wait for a formal approval to take the product to the market,” a Reddy’s spokesman told DNA.
While the company officials refused to put a timeline to the launch, sources said that it would take about 12-18 months for a company to launch its products in the European market following the approvals from the regulator.
According to sources, fondaparinux notches up sales of $140 million and the product manufactured by Reddy’s would be the only authorised generic to hit the market.
Reddy’s, along with the Brisbane, Australia-based Alchemia has already launched the anti coagulant used in the treatment of deep vein thrombosis in the US market in July 2011.
While company officials have declined to provide the details of the fondaparinux sales details in the US, sources said revenues are at about $1.4 million per week and the generic has garnered a market share of about 18%.
The branded sales market of Arixtra was estimated to be at about $340 million by May 2011 and the product was seen having a growth of about 16%. However, the price erosion following the launch of generic version of Arixtra is not known.
A drug marketed by GlaxoSmithKline, Arixtra has been off-patent since 2002. However, Alchemia was granted a US patent covering a manufacturing method involving synthesis of fondaparinux sodium from monosaccharide building blocks.
Pending the approval by the European regulator, Reddy’s is expected to market the drug in a select few key markets of Europe and a decision on selecting the key markets is still being worked out.
