Definition
Regulatory Exclusivity is a period of market protection granted by FDA that prevents approval of generic, biosimilar, or 505(b)(2) applications. Unlike patents, exclusivity is granted by FDA as an incentive for innovation and cannot be challenged in court.
Types of Regulatory Exclusivity
| Exclusivity Type | Duration | Statutory Basis |
|---|---|---|
| New Chemical Entity | 5 years | FD&C Act 505(c)(3)(E) |
| Orphan Drug | 7 years | Orphan Drug Act |
| New Clinical Studies | 3 years | FD&C Act 505(c)(3)(E) |
| Pediatric | +6 months | BPCA |
| Biologic (BPCIA) | 12 years | BPCIA |
| QIDP | +5 years | GAIN Act |
Exclusivity vs Patents
| Feature | Exclusivity | Patents |
|---|---|---|
| Granting Authority | FDA | USPTO |
| Basis | Regulatory incentive | Invention |
| Duration | Fixed by type | 20 years from filing |
| Challengeable | No | Yes (litigation) |
| Geographic Scope | US only | US only |
Why BD Teams Track Regulatory Exclusivity
For business development professionals, exclusivity determines market protection:
- Deal Implication: Exclusivity provides guaranteed protection; patents can be challenged
- Due Diligence Focus: Map all applicable exclusivities and calculate combined protection period
- Opportunity Signal: Multiple overlapping exclusivities enhance asset value