NDA vs ANDA vs 505(b)(1) vs 505(b)(2) vs Orphan Drug in USFDA
NDA vs ANDA vs Orphan Drugs: Understanding which USFDA drug application pathway best fits your product is key to market success. This article compares NDA (505(b)(1)), ANDA, 505(b)(2), and Orphan Drug Designation, with examples of real-world formulations and clarification on PDUFA vs GDUFA fees.
1. NDA (505(b)(1)) – New Drug Application
The 505(b)(1) route requires full submission of preclinical and clinical data for novel molecules.
💰 Fee Type: PDUFA
Subject to PDUFA (Prescription Drug User Fee Act) fees. Estimated cost in FY2025 is ~$4 million for applications requiring clinical data.
| Drug | Brand | Company | Formulation | Indication |
|---|---|---|---|---|
| Osimertinib | Tagrisso | AstraZeneca | Oral Tablet | NSCLC |
| Upadacitinib | Rinvoq | AbbVie | ER Tablet | Rheumatoid Arthritis |
| Lurasidone | Latuda | Sumitomo Pharma | Film-coated Tab | Schizophrenia |
2. ANDA – Abbreviated New Drug Application
Used for generic versions of approved drugs demonstrating bioequivalence.
💰 Fee Type: GDUFA
Subject to GDUFA (Generic Drug User Fee Amendments) fees. FY2025 filing fee is approximately $240,000.
| Generic Drug | Brand (RLD) | Company | Formulation |
|---|---|---|---|
| Atorvastatin | Lipitor | Teva, Aurobindo | Oral Tablet |
| Metformin | Glucophage | Sun Pharma | Oral Tablet |
| Omeprazole | Prilosec | Dr. Reddy’s | Delayed-release Capsule |
3. 505(b)(2) – Hybrid NDA
Used when sponsors rely partly on published data or previous approvals, plus new bridging studies.
💰 Fee Type: PDUFA
Same fee structure as 505(b)(1), governed by PDUFA.
| Drug | Brand | Company | Modification |
|---|---|---|---|
| Treximet | Treximet | Pernix Therapeutics | Combo of Sumatriptan + Naproxen |
| Dextenza | Dextenza | Ocular Therapeutix | New ophthalmic insert |
| DepoSubQ Provera | Depo-SubQ | Pfizer | New route: SC injection |
4. Orphan Drug Designation
A special status granted for drugs treating rare diseases (≤200,000 patients/year in the U.S.). Applied alongside NDA or 505(b)(2).
💰 Fee Type: PDUFA (Often Waived)
PDUFA fees are waived if the sponsor qualifies. Includes 7 years exclusivity and clinical tax credits.
| Drug | Brand | Company | Indication |
|---|---|---|---|
| Spinraza | Spinraza | Biogen | Spinal muscular atrophy |
| Zolgensma | Zolgensma | Novartis | Gene therapy for SMA |
| Trikafta | Trikafta | Vertex | Cystic Fibrosis (CFTR mutation) |
🔍 Comparison Table with Fee Type
| Feature | NDA 505(b)(1) | ANDA | 505(b)(2) | Orphan Drug |
|---|---|---|---|---|
| Drug Type | New entity | Generic copy | Modified or repurposed | Rare disease drug |
| Clinical Trials | Full (Phases I–III) | No | Partial | Varies |
| Fee Type | PDUFA | GDUFA | PDUFA | PDUFA (waived) |
| Market Exclusivity | 5 years | 180 days (first) | 3–5 years | 7 years |
| Cost & Time | High | Low | Medium | Medium to High |
Keywords:
- FDA PDUFA vs GDUFA
- 505(b)(1) vs 505(b)(2) difference
- Orphan drug designation benefits FDA
- ANDA vs NDA FDA approval
- Difference between NDA vs ANDA vs Orphan Drugs
- USFDA drug approval process chart
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