Definition
505(b)(1) is the FDA’s traditional New Drug Application pathway requiring sponsors to submit full reports of safety and effectiveness investigations conducted by or for the applicant. This pathway applies to new molecular entities (NMEs) and drugs where no prior approved product can serve as a reference.
How 505(b)(1) Works
The 505(b)(1) pathway requires sponsors to conduct and submit complete preclinical and clinical data packages. All safety and efficacy evidence must come from studies the sponsor conducted, commissioned, or has rights to reference.
Key Requirements
- Complete preclinical pharmacology and toxicology studies
- Phase 1, 2, and 3 clinical trials
- Full chemistry, manufacturing, and controls (CMC) package
- Comprehensive safety database
- Proposed labeling with full prescribing information
Benefits of 505(b)(1)
Despite higher costs and longer timelines, 505(b)(1) offers advantages:
- 5-Year NCE Exclusivity: New Chemical Entities receive maximum market protection
- Full Data Ownership: Complete control over safety and efficacy data
- No RLD Dependency: Not tied to another product’s regulatory fate
- Strongest IP Position: Comprehensive patent portfolio development opportunity
- Premium Pricing: Novel drugs command higher prices
505(b)(1) vs 505(b)(2)
| Aspect | 505(b)(1) | 505(b)(2) |
|---|---|---|
| Data Source | All sponsor-generated | Own + referenced data |
| Timeline | 10-12 years | 3-5 years |
| Cost | $1-2 billion average | $100-500 million |
| Exclusivity | 5 years NCE | 3 years clinical |
| Best For | New molecules | Modified products |
Why BD Teams Track 505(b)(1)
For business development professionals, 505(b)(1) programs represent significant investment and partnership opportunities:
- Deal Implication: 505(b)(1) programs require substantial capital, making them prime candidates for co-development deals or licensing agreements
- Due Diligence Focus: Evaluate Phase 2/3 data strength, IP runway, and competitive landscape for the indication
- Opportunity Signal: Companies with multiple 505(b)(1) programs often need partners for late-stage development or commercialization