Search FDA Drug and Market Exclusivity

What is a FDA Market Exclusivity?

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FDA market exclusivity is an incentive granted by the FDA and differs from patent exclusivity


What are the market exclusvities and how long do they last?

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Drug exclusivities include, Orphan Drug Exclusivity (ODE) – 7 years, New Chemical Entity Exclusivity (NCE) – 5 years, Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities, New Clinical Investigation Exclusivity – 3 years, Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity, Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only), Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only)


What is pediatric exclusivity?

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Often there is the option for patent holders to seek pediatric exclusivity which often requires additional work. In return for the pediatric work 6 months exclusivity is added to the all existing patents on that product.