FDA Generic Drug Approvals (Trailing 12 Months)

## What this measures

The number of generic drug applications FDA approved for the first time in the 12 months ending with each month.

## Why it matters

A rolling year shows the pace of generic competition without waiting for the calendar year to close.

## How to read it

The peak was 985 in the 12 months to May 2019. In the 12 months to September 2026 FDA approved 700.

## What it does not say

Counts applications, not distinct medicines. Tentative approvals are not counted.

## Source

U.S. Food and Drug Administration, Drugs@FDA, read from the openFDA bulk download. Public domain.