The more traditional types of exclusivity being applied to generics involve change in dosage form, strength and route of administrations. Any unique change to a brand product that requires a clinical study means that it is subject to the availability of exclusivity.
FDA has expanded on this concept in the pediatric area. The goal is to provide an incentive for the brand companies to continue to look into existing products to determine if they can work for the pediatric population. Pediatric exclusivity is granted for 6 months and applies to all applications held by the NDA holder for that active moiety. FDA will push back against the generic industry to allow the brand companies extra protection.
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Topic: page 6 of 6 (Lesson: page 9 of 39)