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Ranbaxy: Cefuroxime Axetil approval - Views on News from Equitymaster
 
 
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  • Feb 18, 2002

    Ranbaxy: Cefuroxime Axetil approval

    Ranbaxy has finally received FDA approval for marketing Cefuroxime Axetil tablets in the US markets. Ceftum (generic Cefuroxime) is a molecule with a market size of US $ 400 m and has already gone off patent in 2000. It may be recalled that Ranbaxy’s application to market generic version of Ceftum (Cefuroxime Axetil) was caught in a long legal tangle.

    We expect Ranbaxy to launch the drug immediately even though the lower court in the US is yet to provide a final ruling on the case. To recall, Glaxo, the original patent holder has obtained an injunction against Ranbaxy’s US subsidiary (RPI) with a US $ 10 m bond, barring the company’s subsidiary from selling generic version of the drug even if it gets the FDA approval. However, RPI had challenged this decision by filing an appeal against the injunction in a higher US Federal circuit court.

    The appeals court however, in its order has already said that Glaxo is not likely to succeed in its action against RPI. In case the court decision comes in favour of Ranbaxy, it would mean a compensation of US $ 10 m against Glaxo’s bond for potential losses due to the injunction.

    We feel that though this approval doesn’t ensure six-month marketing exclusivity, other generic competition for the drug is atleast 3-4 months away. We expect the company to mop a turnover of US $ 60- 80 m from this approval, with 40-50% profit margin.

     

     

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