Exclusivity data from the US FDA Orange Book

The US Food and Drug Administration (FDA) publishes the “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations” in both an annual paper bound edition and web-based searchable database (available here). As part of a larger effort to expand access to government data, the FDA provides monthly updates of the underlying data here.

Note that not all drugs are included in the Orange Book. In particular, most biologic drugs and some antibiotics are not included in the Orange Book.

After downloading a version of the database on November 4, 2012, I ran a few queries relating to patents and non-patent drug exclusivity for the products listed in the Orange Book. Here are some basic statistics.


The Orange book lists 2,492 patents in force that are registered with the FDA has having some type of exclusivity on one or more drugs. These patents are associated with 1,068 products. Patents are associated with both new and old products, including in some cases, products first registered with the FDA in 1960 or 1961.

Eighty nine (89) products are listed as having one or more patents that have been extended six months for pediatric testing.

Non-patent exclusivity

Four hundred and eighty five (485) products have various non-patent exclusivity codes in force. These include such items as test data protection, orphan drug exclusivity, or the Orange Book 180 day patent challenge ANDA exclusivity.

Of the 485 products with non-patent exclusivity codes, 362 products also have one or more patents in force. 123 products have no patents listed in the Orange Book, but are subject to one or more non-patent exclusivity codes.

One hundred and twenty four (124) products have the five year test data exclusivity for new chemical entities (NCE) in force.

Sixty-six (66) products include a code for Orphan Drug Exclusivity (ODE) for one or more indications. The code in the Orange Book database means the exclusivity is currently in force. This period of exclusivity is seven years from the date the orphan indication is approved by the FDA. Some of these products have multiple orphan indications.

Forty-two (42) products have a code for Patent Challenge (PC), which grants the a generic company a 180 days exclusive rights to register a generic drug under an ANDA.