Definition
Pediatric Exclusivity is an additional 6-month period added to all existing patents and exclusivity for a drug when sponsors complete FDA-requested pediatric studies. It rewards companies for studying drugs in children.
How Pediatric Exclusivity Works
FDA issues a Written Request specifying pediatric studies needed. If sponsors complete the studies and submit data, 6 months is added to all existing patents and exclusivity for that drug.
Key Features
- Extends existing protection by 6 months
- Requires completing FDA Written Request
- Applies to all patents and exclusivity for the drug
- Studies must be submitted before patent/exclusivity expiry
- Independent incentive from pediatric drug requirements
Pediatric Exclusivity Value
| Drug Revenue | 6-Month Value |
|---|---|
| $1 billion/year | ~$500 million |
| $5 billion/year | ~$2.5 billion |
| $10 billion/year | ~$5 billion |
Why BD Teams Track Pediatric Exclusivity
For business development professionals, pediatric exclusivity has substantial value:
- Deal Implication: Pending pediatric studies can add significant value if completed before patent expiry
- Due Diligence Focus: Verify Written Request status and timeline for pediatric study completion
- Opportunity Signal: Companies may seek partners to fund or conduct required pediatric studies