FDA Orange Book Archives

Approved Drug Products With Therapeutic Equivalance Evaluations

In addition to its deep database of global drug and patent information, DrugPatentWatch also has archives of the Food and Drug Administration (FDA) Orange Book, or Approved Drug Products With Therapeutic Equivalence Evaluationscatalogs.

The Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act. Each edition includes a list of unexpired patents covering drugs, as of the date of publication.

The history of the Orange Book traces back to 1978 when the FDA set out to compile a list of FDA approved drugs and their generic equivalents. By 1979 the list was completed, and the first edition of the Orange Book was published in 1980.

With the passage of the Hatch-Waxman Act in 1984 the Orange Book scope was expanded to include patents and regulatory exclusivity, helping provide a much-needed objective source of information on branded drugs, the patents covering them, and potential generic entry dates.

Archives of the FDA Orange Book archives are very potent tools for legal and scholarly research, but until now there has been no central source to get the complete set of archives.

DrugPatentWatch is proud to announce the availability of the complete archive of the FDA Orange Book dating back to 1980, in PDF form for immediate download.

► Instant Access (PDF download)


Looking for a browseable database?

The DrugPatentWatch database builds on the Orange Book by incorporating deep data on US and Global Patents, and broad details such as drug formulation, manufacturers, tentative approvals, clinical trials and more. For more details see the DrugPatentWatch Homepage and Subscription Plans

For information on biologics see DrugPatentWatch’s sister site, BiologicPatentWatch.com

Do you have needs beyond DrugPatentWatch’s current offerings? Please contact us.

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