FDA Orange Book: search approved drugs, generics, patents, and exclusivity

The FDA Orange Book, officially "Approved Drug Products with Therapeutic Equivalence Evaluations", is the FDA’s public list of every small-molecule drug product approved under the Federal Food, Drug, and Cosmetic Act. It records brand products approved by New Drug Application (NDA) and generics approved by Abbreviated New Drug Application (ANDA), assigns each multisource product a therapeutic-equivalence (TE) code, and lists the patents and marketing-exclusivity periods that protect it. This tool is a fast, source-linked interface over the official Orange Book data file.

An NDA is a brand (originator) application that carries the full clinical evidence of safety and effectiveness; an ANDA is a generic application that relies on FDA’s prior finding for a reference-listed drug (RLD) instead of repeating the clinical program. The Orange Book ties them together: each generic references the brand it copies, and the TE code tells you whether they are substitutable. Search by ingredient, brand, applicant, or application number, or filter to brand-only or generic-only above.

TE codes tell you whether a generic can be substituted for the brand. Codes starting with "A" (AA, AB) mean FDA considers the product therapeutically equivalent and substitutable; "AB" specifically means bioequivalence questions have been resolved with adequate evidence. Codes starting with "B" (e.g. BX) mean FDA does not consider the product therapeutically equivalent at this time. The trailing number (AB1, AB2) groups products equivalent to each other but not across groups.

Orange Book patents are those an NDA holder submits under 21 U.S.C. 355, each with an expiration date and drug-substance / drug-product / method-of-use flags. Marketing exclusivity is separate: NCE (5-year), ODE (7-year orphan), and pediatric (+6 months) are common. A brand loses protection when its last patent or exclusivity lapses; see the drug patent cliffs report for the loss-of-exclusivity timeline computed from this data, and use the Timeline view above to spot a single product’s cliffs.

A product’s marketing status is Prescription (Rx), Over-the-counter (OTC), or Discontinued, meaning it is no longer marketed and FDA has moved it to the Discontinued Drug Product List. Filter by marketing status to list discontinued products. For biologics (monoclonal antibodies, insulins, and other large molecules) and biosimilars, use the FDA Purple Book instead; the Orange Book covers small-molecule drugs only.