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Last Updated: June 23, 2021

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Orange Book PDF for Edition 5, Supplement 9

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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

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Serving leading biopharmaceutical companies globally:

Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.