Pediatric Exclusivity
A six-month extension of all existing marketing exclusivities and patent protections granted to a drug sponsor that completes pediatric studies requested by the FDA. Established under the FDA Modernization Act and extended by the Best Pharmaceuticals for Children Act (BPCA). Applies to all formulations and indications of the active moiety, not just the pediatric product.
Örnekler
- Lipitor (atorvastatin) pediatric exclusivity worth ~$1B
- Strattera (atomoxetine) for pediatric ADHD
- Norvasc (amlodipine) pediatric hypertension studies
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A six-month extension of all existing marketing exclusivities and patent protections granted to a drug sponsor that completes pediatric studies requested by the FDA. Established under the FDA Modernization Act …