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What is the FDA Orange Book?

Method · December 2022

DOI: 10.13140/RG.2.2.27115.82721

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Pranita Dharmadhikari
Case Western Reserve University
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What is the FDA Orange Book?

https://www.accessdata.fda.gov/

The FDA Orange Book is a publication by the United States Food and
Drug Administration (FDA) that lists all the drugs approved for use in
the country. It includes brand-name and generic drugs and any
therapeutic equivalents that the FDA has approved.

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The Orange Book is officially called the “Approved Drug Products

with Therapeutic Equivalence Evaluations” and is named after its
orange cover. It was first published in 1980 and is updated regularly
to reflect new approvals and changes to existing drugs.

The Orange Book is an essential resource for healthcare

professionals, as it provides information on the safety and
effectiveness of approved drugs. It also helps doctors and
pharmaceutical professionals determine which drugs can be
substituted for each other based on their therapeutic equivalence.
This can be useful in cases where a patient may need to switch to a
different drug due to cost or availability.

In addition to listing approved drugs, the Orange Book also includes

information on patents or exclusivity granted for each drug. This is
important for drug manufacturers, as it helps them protect their
investments and maintain market exclusivity for better competition
in the market.

The FDA Orange Book is divided into four main sections:

1. Approved Drug Products: This section lists all the drugs

approved by the FDA, their active ingredients, dosage forms,
and strengths. It also includes any therapeutic equivalents that
have been approved, as well as any changes or updates to the
drug’s labeling or manufacturing processes.

2. Therapeutic Equivalence Evaluations: This section provides

information on the therapeutic equivalence of different drugs.

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It includes both “A” and “B” ratings, with “A” ratings indicating
that two drugs are considered therapeutically equivalent and
can be substituted for each other and “B” ratings indicating that
the drugs may not be regarded as interchangeable.

3. Reference Listed Drugs (RLDs): This section lists the “reference

listed drugs” for each approved drug product and the drugs used
as the basis for the FDA’s approval. This information helps
determine the therapeutic equivalence of different medications.

4. Patents and Exclusivity: This section includes information on

patents or exclusivity periods for each approved drug. This can
be useful for drug manufacturers, as it helps them protect their
investments and maintain market exclusivity.

In addition to its use in the healthcare industry, the Orange Book is

also a valuable resource for researchers and policymakers. It
provides essential information on the safety and effectiveness of
approved drugs and can be used to help identify areas for further
research or potential changes to drug regulation.

Follow me to learn more.

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