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FDA Market Exclusivity
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Search FDA Drug and Market Exclusivity

Over 1,900 SKUs with FDA market exclusivity

FDA Market Exclusivity Over 1,900 records on market exclusivity

FDA data updated weekly
Application Trade Name Drug Strength Company Expiry Exclusivity

Search FDA Market Exclusivity

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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Data Sources 200,000 records

Dailymed - Continuously Updates
OpenFDA - Continuous Updates
Federal Supply Schedule Pricing - Daily
Drugs@FDA - Weekly
Orange Book - Weekly
483s - Weekly
Warning Letters - Weekly
Drug Patents - Weekly
FDA Inspections - Weekly
DMF files - Quarterly
Data dependant on timing of updates to source data. WIZMED nor any of its agencies, contractors, subcontractors or employees does not make any warranties, expressed or implied, with respect to data contained in these databases or files, and, furthermore, assume no liability for any party's use, or the results of such use, of any part of the database or files.