Pravachol Exclusivity Case Remanded To FDA By Appeals Court
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA needs to develop policy to determine whether a voluntary patent case dismissal triggers exclusivity, the court said.
You may also be interested in...
Teva’s Generic Pravachol Will Be Approved – With Exclusivity, FDA Decrees
FDA has determined that a court dismissal does not constitute a decision under the “court decision trigger” provision, although the agency’s stance must be affirmed by the D.C. district court.
Teva’s Generic Pravachol Will Be Approved – With Exclusivity, FDA Decrees
FDA has determined that a court dismissal does not constitute a decision under the “court decision trigger” provision, although the agency’s stance must be affirmed by the D.C. district court.
Teva Loses Pravachol Exclusivity Period; Multiple Generics To Launch In 2006
FDA tells Teva that the 180-day exclusivity period for three pravastatin doses expired in February. As a result, as many as six companies – including Teva – could be in a position to launch generic Pravachol when Bristol’s composition of matter patent expires in April 2006. Teva plans to sue FDA to reinstate its first-to-file exclusivity period.