Approved Drug Products with Therapeutic Equivalence Exclusivity

$716 / year

This dataset is also called Orange Book. The dataset contains application type, exclusivity code, exclusivity date etc for approved drug products with therapeutic equivalence.


The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).
The Approved Drug Products list first appeared as a print publication in October 1980. With the 25th edition (2005), Portable Document Format (PDF) versions of the Annual Edition and the Cumulative Supplement became available.
The Orange Book Search was added to the FDA website October 31, 1997.

Date Created


Last Modified




Update Frequency


Temporal Coverage

1981 to 2019-05

Spatial Coverage

United States


John Snow Labs; U.S. Food and Drug Administration;

Source License URL

Source License Requirements


Source Citation



Approved Drug, Therapeutic Equivalence, Drug Exclusivity, Drug Book, Orange Book, Generic Drug Products, Drugs List, FDA Approved Drug Products

Other Titles

Exclusivity of Newly Approved Drug, Exclusivity of Approved Drug Product, Exclusivity of Drugs with Therapeutic Equivalence, Drug Book Products with Therapeutic Equivalence Evaluations Exclusivity, Drug Products with Therapeutic Equivalence Evaluations Exclusivity Orange Book, Generic Drug Products with Therapeutic Equivalence

Application_TypeThe type of new drug application approval. New Drug Applications (NDA or innovator) or Abbreviated New Drug Applications (ANDA or generic).stringrequired : 1
Application_Noo New Drug Application (NDA) Number. The FDA assigned number to the application.integerrequired : 1 level : Nominal
Product_NoThe FDA assigned number to identify the application products. Each strength is a separate product. May repeat for multiple part products.integerrequired : 1 level : Nominal
Exclusivity_CodeCode to designate exclusivity granted by the FDA to a drug product.stringrequired : 1
Exclusivity_DateThe date the exclusivity expires. Format is YYYY-MM-DD.daterequired : 1
New Drug Applications (NDA or innovator)221283NS2019-11-04
New Drug Applications (NDA or innovator)221284NS2019-11-04
New Drug Applications (NDA or innovator)221282NS2019-11-04
New Drug Applications (NDA or innovator)221281NS2019-11-04
New Drug Applications (NDA or innovator)221452NS2020-05-26
New Drug Applications (NDA or innovator)225222NS2021-01-23
New Drug Applications (NDA or innovator)225272NS2021-05-11
New Drug Applications (NDA or innovator)220631NP2020-06-20
New Drug Applications (NDA or innovator)220632NP2020-06-20
New Drug Applications (NDA or innovator)220633NP2020-06-20