IPData Lab - Data collections: Orange Book

Comprehensive data for all FDA-approved biological drugs

IPDataLab understands the significance of data quality to our customers in the pharmaceutical industry. Thus, our PurpleBook patent database is manually curated by domain experts and measured via 4 key criteria: reliability, accuracy, depth, granularity.

RELIABLE
Each patent in our database was either actively disclosed by the owner or the subject of a term extension application, plus we also include related patents (continuation, divisional, and continuation-in-part applications) thereof, i.e., all directly linked to a drug. This supports focused research about a drug by avoiding search noise. Our data supports efficient Freedom to Operate analysis by providing convenient access to key patent information about each drug.

ACCURATE
Patent expiry date is of ultimate importance for pharmaceutical companies because it determines the generic entry date of a drug. In our data system, a sophisticated algorithm produces the most accurate patent expiry date possible, taking into consideration patent term extension (PTE), patent term adjustment (PTA), terminal disclaimers, maintenance fee payment status, etc.

IN-DEPTH
New metadata fields not available in the standard PurpleBook are provided. This metadata conveniently enables search across all fields, which in turn supports deep analytical insights. For example, we extract biological target and indication from drug label documents, and for each extended patent, not only applied extension days but also granted extension days are provided.

GRANULAR
Both approved drugs and patents are linked in our system on the most granular level. New indications of an existing drug can be found via the new indication-approval date mapping, which offers a quick overview of drug development trends. For extended patents, specific claims are identified, and a claims-product mapping explains why the claims read on the drug product, thereby enabling a quick drill down to the most critical information.

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.

Orange Book Patent Data

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

123,456

40 Million+

99.9%

Comprehensive data for all FDA-approved biological drugs

Data Overview

Backfile and Updates

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