Friday, May 24, 2013

Generic Isotretinoin market likely to get crowded as more players are eying a pie

Pierre Fabre  the third largest French pharmaceutical company,  has initiated a bio equivalence study comparing V0057 Versus a Reference Formulation of isotretinoin. The study is expected to complete in June 2013 and an ANDA filing can  be expected soon. In the last 18 months, we have seen three new entrants in the generic istotretinoin space. The most recent entrant being India based Dr. Reddy. Prior to Dr. Reddy, Ranbaxy and Douglas pharma have entered the market. 
Ranbaxy holds a unique advantage over other generic competitors as it has been able to develop a superior formulation which allows the drug to be taken with any diet, unlike generic isotretinoin which needs to be taken with a high fat diet to ensure better bioavailability.

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