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Colorcon
McKesson
Dow
Merck
McKinsey
Mallinckrodt

Last Updated: August 9, 2020

Free DrugPatentWatch Orange Book PDF Library

Approved Drug Products with Therapeutic Equivalence Evaluations

Historical copies of the FDA Orange Book (formally known as Approved Drug Products with Therapeutic Equivalence Evaluations) are potent tools for scholarly research and for litigation support, but until now there has been no central source to get the complete set of archives.

In response to client requests, DrugPatentWatch issued Freedom-of-Information requests to the Food and Drug Administration and also obtained copies of the Orange Book from libraries around the world. The team at DrugPatentWatch is proud to make this resource freely available.

A comprehensive business intelligence tool

In addition to the comprehensive downloadable Orange Book library, DrugPatentWatch also extends the Orange Book with its dynamic platform of international business intelligence on biologic and small-molecule drugs. The business intelligence platform is revised daily and enables complex searches, email updates, and information in litigation, drug prices, and more.

The DrugPatentWatch database builds on the Orange Book by incorporating deep data on US and Global Patents, and broad details such as abandoned and pending patent applications, drug formulation, manufacturers and suppliers, tentative approvals, clinical trials and more. For more details see the DrugPatentWatch homepage and flexible subscription options

Orange Book Annual Editions 

Orange Book Monthly Supplements 

6th edition (1985)
7th edition (1987)
8th edition (1988)
9th edition (1989)
10th edition (1990)
11th edition (1991)
12th edition (1992)
13th edition (1993)
14th edition (1994)
15th edition (1995)
16th edition (1996)
17th edition (1997)
18th edition (1998)
19th edition (1999)
20th edition (2000)
21st edition (2001)
22nd edition (2002)
23rd edition (2003)
24th edition (2004)

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
McKesson
Colorcon
Baxter
Mallinckrodt

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