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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