Daytrana is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder.
As part of the deal, Noven will grant Actavis a non-exclusive, royalty-bearing license to market its generic Daytrana starting from 01 September 2015, or earlier under certain circumstances.
The firms have not disclosed other details of the settlement.
Launch of Actavis’ product is contingent upon Actavis receiving final approval from the US Food and Drug Administration (FDA) on its abbreviated new drug application (ANDA) for generic Daytrana.
Based on available information, Actavis believes it may be a first applicant to file an ANDA for the generic version of Daytrana and if approved, it may be entitled to 180 days of generic market exclusivity.
Actavis is focused in the development and manufacturing of generic, brand, branded generic, legacy brands and over-the-counter (OTC) pharmaceutical products and has commercial operations in about 60 countries.