Definition
Orange Book is FDA’s official publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations.” It lists all drugs approved under the FD&C Act, their therapeutic equivalence ratings, patent information, and exclusivity status.
How the Orange Book Works
The Orange Book serves multiple purposes in the pharmaceutical ecosystem, providing transparency on approved products and enabling generic development.
Key Information Included
- All FDA-approved drug products
- Therapeutic equivalence codes
- Patent listings and expiration dates
- Exclusivity periods and types
- Reference Listed Drug designations
Therapeutic Equivalence Codes
| Code | Meaning |
|---|---|
| AA | No bioequivalence problems |
| AB | Bioequivalence demonstrated |
| AN | Aerosol products |
| AT | Topical products |
| BC | Extended-release dosage forms |
| BN | Nebulizer products |
| BX | Insufficient data |
Why BD Teams Track Orange Book
For business development professionals, Orange Book data is essential:
- Deal Implication: Patent and exclusivity listings determine generic entry timing and licensing opportunities
- Due Diligence Focus: Verify all relevant patents are listed and assess Paragraph IV exposure
- Opportunity Signal: Products approaching patent expiry create authorized generic partnership opportunities