Microproduct data guideintermediate

FDA Orange Book

Approved drug products with therapeutic-equivalence, patent, and exclusivity dates for building generic-entry and substitution-research tools.

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At a glance

Difficulty
Intermediate — some data preparation helps
Size
Tiny · ≤0.05 GB
Formats
TXT, CSV
Access
Download
API key
Not required
Provider
U.S. Food and Drug Administration
Updates
Monthly
Data terms
U.S. Government public data / federal copyright guidance

From source to product signal

Test a product idea in four steps

The Orange Book lists FDA-approved products with therapeutic-equivalence codes, patents, and exclusivity. Start with products.txt from the published zip. Exclusivity dates are not a guaranteed generic-entry day, and omitted patents can still block substitution.

1

Check the setup

  • Python 3.10 or newer
  • A notebook environment such as Jupyter or Google Colab
  • An internet connection
2

Access the data

  1. 1.Open the Orange Book data-files page and the federal public-data copyright page.
  2. 2.Download the published zip and read products.txt with the documented tilde delimiter.
  3. 3.Keep application number, trade name, and therapeutic-equivalence code.
Open official source
3

Run the Python example

Install the packages, then run the notebook cell.

python -m pip install pandas requests

import io
import zipfile

import pandas as pd
import requests

response = requests.get(
    "https://www.fda.gov/media/76860/download",
    timeout=30,
)
response.raise_for_status()
with zipfile.ZipFile(io.BytesIO(response.content)) as archive:
    products = pd.read_csv(archive.open("products.txt"), sep="~")
sample = products[products["Trade_Name"].str.upper() == "LIPITOR"]
print(sample[["Appl_No", "Trade_Name", "Ingredient", "TE_Code", "Approval_Date"]].head())
4

Test a useful signal

Inspect one brand's approved products and exclusivity

Test whether Orange Book fields can support a bounded generic-entry review.

  1. 01Keep application number, trade name, ingredient, and TE code for Lipitor.
  2. 02Join patent.txt or exclusivity.txt on application number only when those dates are present.
  3. 03Explain that remaining patents, litigation, and supply can move generic entry after an exclusivity date.

Dataset details

U.S. Food and Drug Administration is a government source. Last verified 2026-08-18. Temporal coverage: currently listed approved products.

Theme

Health, Food & Safety

Domains

PharmaceuticalsRegulationHealth Care

Data types

Registry DataTabular

Tasks

Market ResearchPatent ResearchProduct Lookup

Geography

United States

Formats

TXTCSV

Provider

U.S. Food and Drug Administration

Data terms

U.S. Government public data / federal copyright guidance