This chart shows the companies which have received the most pediatric exclusivities in the past five years.
Pediatric exclusivity is granted to drug companies for conducting pediatric studies on their drugs, following a FDA request to do so.
A unique aspect of pediatric exclusivity, relative to the other FDA-granted exclusivities, is that the term
of pediatric exclusivity starts when patents expire. Accordingly, unlike other regulatory exclusivities which tend to run concurrent with patents and expire before patents,
pediatric exclusivity provides protection beyond the patent-protected period.
The companies with the most pediatric exclusivities are:
- Novartis
- Allergan
- Bristol Myers Squibb
- Takeda
- Alcon Labs Inc
- Biomarin Pharm
- Currax
- Gilead Sciences Inc
- Helsinn
- Hoffmann La Roche
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