ANDA vs NDA – Key Differences, Costs, Timelines & Regulatory Strategy

June 20, 2025 Admin

ANDA vs NDA: When it comes to launching a pharmaceutical product in the United States, choosing the correct regulatory submission pathway is critical.

The FDA provides two primary avenues for drug approvals — the New Drug Application (NDA) and the Abbreviated New Drug Application (ANDA).

Also Read: How to Register a Drug with USFDA – A Complete Submission Guide

Each route comes with its own set of requirements, timelines, and regulatory implications.

This detailed guide compares ANDA vs NDA, explains the key differences, and helps you determine the right submission strategy for your product.

Table of Contents

📘 What is an NDA (New Drug Application)?

An NDA is the regulatory submission made to the U.S. Food and Drug Administration (USFDA) when seeking approval to market a new drug in the United States.

This pathway is used when the drug:

Contains a new active ingredient (NCE)
Represents a new indication, dosage, or formulation
Is a new combination of previously approved drugs
Includes new delivery methods or labeling claims

📦 NDA Contents:

Section	Description
Administrative	FDA forms, cover letters
Quality Data	Chemistry, manufacturing, and control (CMC)
Non-Clinical	Animal pharmacology and toxicology
Clinical	Human safety and efficacy data
Labeling	Proposed package insert, carton

✅ NDAs are submitted in eCTD format and require full review of safety and efficacy.

📗 What is an ANDA (Abbreviated New Drug Application)?

An ANDA is a streamlined application submitted to the USFDA for approval of a generic version of a previously approved branded (reference) drug.

It does not require new clinical data, as it relies on:

Pharmaceutical equivalence
Bioequivalence (BE)
Same route of administration, strength, dosage form, and labeling

🔍 Key Characteristics of ANDA:

Must demonstrate bioequivalence to RLD (Reference Listed Drug)
No animal or human efficacy trials required
Abbreviated data requirement
Costs significantly less than an NDA

📊 Key Differences Between ANDA vs NDA

Feature	NDA	ANDA
Purpose	New drugs	Generics
Data Required	Full clinical and preclinical data	Only bioequivalence (BE) data
Cost	High (millions USD)	Low to moderate
Timeline	10–12 months (Standard)	8–10 months
Patent Certification	Not applicable at filing	Para IV/III/II/Certification needed
Exclusivity	5 years (NCE), 3 years (others)	180-day exclusivity (Para IV)

🔬 Clinical Trial Requirements

NDA:

Requires full Phase I to III clinical trials
Must submit data showing safety and efficacy in humans

ANDA:

Requires bioequivalence (BE) study only
Clinical trials are not needed if BE is demonstrated

💰 Cost Considerations

Item	NDA	ANDA
Development Cost	$50M–$2B	$1M–$5M
USFDA Application Fee (2025)	~$4,000,000	~$250,000
User Fees (GDUFA III)	Additional per site	ANDA-specific facility fees

ANDA vs NDA cost difference is one of the key reasons why generic manufacturers prefer the abbreviated route.

🕒 Approval Timelines

NDA (Standard Review): 10–12 months
NDA (Priority Review): 6 months
ANDA: ~10 months (can be longer under GDUFA backlog)

🧩 ANDA Filing Requirements

Reference Listed Drug (RLD) selection
Comparative dissolution profile
In vitro and in vivo bioequivalence studies
Stability data for 6 months (accelerated) and 3 months (long-term)
DMFs (Drug Master Files) for APIs

📜 NDA Filing Requirements

IND (Investigational New Drug) approval before trials
Complete CMC documentation
Pre-clinical animal study reports
Full clinical trial data
Proposed REMS (if applicable)

🔍 ANDA Paragraph Certifications

Under Hatch-Waxman Act, ANDA filers must certify one of the following:

Para I: No patent listed
Para II: Patent expired
Para III: Will wait for patent expiry
Para IV: Patent is invalid or will not be infringed (can lead to 180-day exclusivity)

🧠 When Should You File an NDA?

✅ Use the NDA route if:

The drug is new to the U.S. market
You have innovative delivery or formulation
Your product needs new safety/efficacy evaluation

💡 When Should You File an ANDA?

✅ Use the ANDA route if:

Your drug is a generic of an already approved NDA
You can prove bioequivalence
Your product uses the same API, route, strength, and dosage form

🔁 What is a 505(b)(2) NDA?

It’s a hybrid application that relies partly on published literature or previously approved products.

Used when:

You’re changing dosage form
Adding new route of administration
Reformulating or combining known drugs

It blends NDA and ANDA characteristics.

❓ FAQs – ANDA vs NDA

Q1. Can a company file both NDA and ANDA?
Yes, depending on the drug type. Companies often have both innovative and generic divisions.

Q2. Is ANDA only for oral solids?
No. ANDA can be used for injectables, creams, inhalers—if BE can be demonstrated.

Q3. Can ANDA be converted into NDA later?
No. They are structurally different filings. However, a 505(b)(2) can be considered as a bridge.

Q4. Is exclusivity possible for ANDA?
Yes. Para IV ANDA filers get 180-day exclusivity if they are the first to challenge a patent.

✅ Conclusion – ANDA vs NDA

Choosing between ANDA vs NDA depends entirely on the nature of your product, regulatory history, and strategic goals. NDAs offer innovation and exclusivity but come with high costs and complex data needs.

ANDAs provide a faster, cost-effective route but are limited to generics that closely match the reference drug.

Careful evaluation of your formulation, IP strategy, and clinical data is essential to choose the right FDA pathway and avoid regulatory delays.