Definition
Data Exclusivity is a form of regulatory protection that prevents FDA from relying on the innovator’s clinical data to approve generic, 505(b)(2), or biosimilar applications. It protects the investment in generating safety and efficacy data.
How Data Exclusivity Works
During the exclusivity period, FDA cannot reference the innovator’s clinical data package to approve competing products. Competitors must generate their own data or wait for exclusivity to expire.
Types of Data Exclusivity
| Type | Duration | Trigger |
|---|---|---|
| NCE (Small Molecule) | 5 years | New chemical entity |
| New Clinical Studies | 3 years | Studies essential for approval |
| Biologic Reference Product | 12 years | Original BLA approval |
| Biosimilar Filing Allowed | 4 years | From reference product approval |
Data Exclusivity vs Patents
| Aspect | Data Exclusivity | Patents |
|---|---|---|
| Granted By | FDA | USPTO |
| Protects | Clinical data use | Inventions |
| Duration | Fixed (5/12 years) | 20 years from filing |
| Challenge | Cannot be challenged | Paragraph IV litigation |
Why BD Teams Track Data Exclusivity
For business development professionals, data exclusivity defines competitive windows:
- Deal Implication: 12-year biologic exclusivity significantly impacts valuation and deal terms
- Due Diligence Focus: Calculate exclusivity expiry and biosimilar competition timeline
- Opportunity Signal: Assets approaching data exclusivity expiry may need lifecycle strategies