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Trade Name Drug Strength Company Expiry Exclusivity

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What is a FDA Market Exclusivity?

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?

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?

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.

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