Definition
ANDA (Abbreviated New Drug Application) is the FDA pathway under Section 505(j) for approving generic versions of previously approved drugs. ANDAs demonstrate that the generic is bioequivalent to the Reference Listed Drug (RLD) without requiring independent clinical trials for safety and efficacy.
How ANDA Works
The ANDA process allows generic manufacturers to rely on the FDA’s prior finding that the brand-name drug is safe and effective. Instead of clinical trials, sponsors submit bioequivalence studies showing the generic performs identically to the RLD.
Key Requirements
- Bioequivalence studies demonstrating same rate and extent of absorption
- Chemistry, manufacturing, and controls (CMC) documentation
- Labeling identical to the RLD (with certain permitted differences)
- Patent certifications (Paragraphs I, II, III, or IV)
- Facility compliance with current Good Manufacturing Practice (cGMP)
Benefits of ANDA
The abbreviated pathway offers significant advantages:
- No Clinical Trials: Rely on RLD’s established safety and efficacy
- Faster Development: 2-3 year timeline vs 10+ years for NDA
- Lower Costs: $2-5 million vs $1+ billion for new drugs
- 180-Day Exclusivity: First Paragraph IV filer receives market protection
- Established Market: Clear demand for lower-cost alternatives
ANDA vs 505(b)(2)
| Aspect | ANDA | 505(b)(2) |
|---|---|---|
| Product Type | Exact generic copy | Modified product |
| Clinical Data | Bioequivalence only | May require clinical studies |
| Exclusivity | 180-day (first filer) | 3-year for new clinical data |
| Labeling | Same as RLD | Can differ from RLD |
| Best For | Identical generics | New formulations, combinations |
Recent ANDA Trends
The FDA approved over 900 ANDAs in 2024, with generic competition driving down drug costs. Key trends include:
- Complex generics (inhalers, injectables) receiving increased attention
- ANDA Prioritization Pilot for US-manufactured generics
- Focus on reducing drug shortages through expedited ANDA review
Why BD Teams Track ANDA
For business development professionals, ANDA filings signal competitive dynamics:
- Deal Implication: Paragraph IV ANDA filings trigger patent litigation and potential settlements, creating licensing opportunities
- Due Diligence Focus: Track ANDA submissions against your portfolio’s key products to anticipate generic entry
- Opportunity Signal: Companies with ANDA capabilities are valuable partners for authorized generic strategies