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Re: DewDiligence post# 59415

Friday, 02/22/2008 3:27:24 PM

Friday, February 22, 2008 3:27:24 PM

Post# of 257257
Upon U.S. approval, Copaxone was granted Hatch-Waxman exclusivity (5 years) and Orphan Drug status (7 years). Those expired on 2001 and 2003 respectively.
Generic manufacturers were allowed to file a Paragraph IV at year 4 of the exclusivity period. So Copaxone generics could technically be file back in 2000.
I think there's more than one reason why it was not challenged yet.

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