Tuesday, December 11, 2012

USFDA once again denies Teva petition to preset ANDA requirements for Copaxone generics

For the fourth time Teva's petition to  to the USFDA claiming that generic Copaxone should be approved only if it meets preset criteria has been rejected. According to Teva, Copaxone is a complicated drug to copy. In Teva's latest petition to the FDA a new claims was introduced claiming that Teva is a colloidal substance, a chemical mixture with specific properties and thus competitors must prove bioequivalence and that absorption into the body of patients is similar to the branded version. 

Teve is desperately attempting to delay generic competition to its flagship branded drug Copaxone for the treatment of multiple sclerosis. Sandoz/Momenta and Mylan/Natco have an ANDA  In the event generic companies are foreced to conduct clinical trials, Teva would get a couple of more years in market exclusivity.  Teva's dependence on Copaxone is immense. Sales in the first nine months of 2012 of the injectable treatment reached $2.94 billion, mainly in the US. The net profit margins from Copaxone sales could be as high as 75 percent. 
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