Dr Reddy’s Laboratories Ltd succeeded in getting US Food and Drug Administration approval for the launch of fondaparinux, meeting one of its key valuation triggers for 2011-12. Its stock price rose 3.3% on Wednesday as shareholders priced in a bump-up in earnings per share.

Dr Reddy’s had forecast, at the time of its 2010-11 results, that it expects its US generics business to provide a big boost to growth in the current fiscal, which was contingent upon a few key product launches and supplies from US-based facilities. Fondaparinux, or the generic version of GlaxoSmithKline Plc’s (GSK) Arixtra—a blood thinning drug—was one of those product launches.

Dr Reddy’s US generics business contributed about 35% to the company’s 2010-11 global generics revenue of 5,334 crore.

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In 2010, GSK’s US-market sales of Arixtra were £177 million (around 1,260 crore today) and rose 25% in constant currency terms. In the March quarter, sales were up 15% year-on-year.

Dr Reddy’s will be marketing the only generic copy of the drug. That provides a buffer against any price erosion that occurs when a generic drug enters the market. The technology for making this drug is expected to be a significant barrier to the entry of other generics. An authorized generic from GSK will, of course, take the total number of products to three.

Dr Reddy’s has a licence from Australian pharmaceutical firm Alchemia Ltd to make and sell this drug. In return, it will share about 50-60% of its US-market operating profits from selling this drug. In addition, it has a separate agreement with Alchemia for Europe, where a launch is expected after 2012, which is royalty-based.

Dr Reddy’s has said it will start introducing the drug in a phased manner in the US market. Thus, the full impact will be visible from the December quarter onwards.

Profit will get a boost, assuming a 30% US market share, which is conservative, and there is minimal price erosion. Considering its 2010-11 adjusted earnings before interest, tax, depreciation and amortization of 1,642 crore, the incremental impact may not be dramatic. But no generic competition is expected for a few years, and the market for this drug is growing, making it a valuable win.

Thus, fondaparinux can provide a steady and profitable revenue stream to Dr Reddy’s for a number of years, compared with other generic launches, where a number of generic players enter the market after the six-month exclusivity period ends. The launch also sets the stage for good growth in Dr Reddy’s main US generics market segment, as it has also got recent approvals and launches for other drugs.

Graphics by Yogesh Kumar/Mint

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