Abbreviated New Drug Application (ANDA)

Key facts

Legal basis

Section 505(j) of the Federal Food, Drug, and Cosmetic Act

Created by

Drug Price Competition and Patent Term Restoration Act of 1984

Regulations

21 CFR Part 314

Reviewed by

Office of Generic Drugs, within CDER

Core requirement

Sameness to the reference listed drug plus bioequivalence

What is an ANDA?

An ANDA is abbreviated because it does not include new preclinical or clinical studies to prove safety and effectiveness. Instead, the applicant shows its product matches a Reference Listed Drug (RLD) in the ways that matter and delivers the active ingredient to the body at the same rate and extent.

Before 1984 there was no general abbreviated pathway for drugs approved after 1962, so makers of copies often had to repeat safety and effectiveness studies. The Hatch-Waxman Act created the ANDA pathway in Section 505(j), balanced by patent term restoration and new exclusivities for brand companies.

The first applicant to submit a substantially complete ANDA with a Paragraph IV patent certification can earn 180 days of generic exclusivity.

What an ANDA must show

Compared with its reference listed drug, a generic approved through an ANDA must generally have:

• The same active ingredient, strength, dosage form and route of administration.
• The same conditions of use and essentially the same labeling, with permitted differences such as carved-out patented indications.
• Bioequivalence, usually shown in pharmacokinetic studies comparing drug levels in the blood.
• Manufacturing that meets current good manufacturing practice (CGMP) requirements.
• A certification or statement for each patent listed in the Orange Book for the reference drug.

Why ANDAs matter

ANDA approvals are the leading indicator of price erosion for small-molecule drugs. When patents and exclusivities end, the first generics typically enter at a discount, and prices tend to fall further as more ANDA holders launch. Pharmacy acquisition cost benchmarks such as NADAC capture that decline.

Not every approval means a launch. The FDA grants tentative approval when a generic meets all scientific requirements but is still blocked by patents or exclusivity, and some fully approved ANDAs are never marketed. Confirm launch status through NDC listings or claims data rather than approval dates alone.