Orange Book Patent Data
IPData Lab

Accurate, and easy access to patent information for FDA-approved chemical drugs

IPDataLab’s Orange Book patent database links FDA-approved chemical drug and patent data, offered as a combo with the Purple Book patent database, thereby allowing searching drugs and patents across both databases.

IPData Lab

IPData Lab Data Overview

Application Number The FDA assigned number to the application.
Product The trade name of the product as shown on the labeling.
Applicant Short Name The firm name holding legal responsibility for the new drug application. The firm name is condensed to a maximum twenty character unique string.
Applicant The full name of the firm holding legal responsibility for the new drug application.
Active Ingredient The active ingredient(s) for the product. Multiple ingredients are in alphabetical order, separated by a semicolon
Type The type of new drug application approval. New Drug Applications (NDA or innovator) are ”N”. Abbreviated New Drug Applications (ANDA or generic) are “A”.
Strength The potency of the active ingredient. May repeat for multiple part products.
Dosage Form The physical form that delivers a dose of the drug.
Route of Administration A way of administering a drug to a site in a patient.
Status The group or category of approved drugs. Format is RX, OTC, DISCN.
Approval Date The date the product was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".
Ref. Product The Reference Listed Drug (RLD) is a drug product approved under section 505(c) of the FD&C Act for which FDA has made a finding of safety and effectiveness.
RS A reference standard (RS) is the drug product selected by FDA that an applicant seeking approval of an ANDA must use in conducting an in vivo bioequivalence study required for approval of an ANDA.
TE Code The therapeutic Equivalence (TE) Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Product Number The FDA assigned number to identify the application products. Each strength is a separate product. May repeat for multiple part products.
Exclusivity Code Code to designate exclusivity granted by the FDA to a drug product.
Exclusivity Date The date the exclusivity expires. Format is MMM DD, YYYY.
Patent Number Patent numbers as submitted by the applicant holder for patents covered by the statutory provisions. May repeat for multiple applications and multiple products. Includes pediatric exclusivity granted by the agency.
Expire Date The date the patent expires as submitted by the applicant holder including applicable extensions. The format is MMM DD, YYYY.
Drug Substance Flag Patents submitted on FDA Form 3542 and listed after August 18, 2003 may have a drug substance flag indicating the sponsor submitted the patent as claiming the drug substance. Format is Y or null.
Drug Product Flag Patents submitted on FDA Form 3542 and listed after August 18, 2003 may have a drug product flag indicating the sponsor submitted the patent as claiming the drug product. Format is Y or null.
Patent Use Code Code to designate a use patent that covers the approved indication or use of a drug product. May repeat for multiple applications, multiple products and multiple patents.
Submission Date The date on which the FDA receives patent information from the new drug application (NDA) holder. Format is Mmm d, yyyy.
Patent Delist Request Flag Applicant has requested patent be delisted.
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