The FDA Orange Book lists approved drug products with their therapeutic equivalence ratings, patents and exclusivity periods. Here is how to search the Orange Book, what it can and cannot tell you about generic entry, and how ClinicaLister shows a drug's listed patents and exclusivity beside its trials and approvals.
The Orange Book — formally Approved Drug Products with Therapeutic Equivalence Evaluations — identifies drug products FDA has approved on the basis of safety and effectiveness. It is the reference pharmacists, generic manufacturers and payers use to decide which products can be substituted for one another.
For each product it gives the active ingredient, proprietary name, applicant, strength, dosage form, route and a therapeutic equivalence (TE) code — for example AB for a generic rated equivalent to its reference product. For new drug applications it also lists the patents the company has submitted to FDA and the exclusivity periods FDA has granted.
Those patent and exclusivity listings are what generic and competitive-intelligence teams read to estimate when a product could face generic competition, which is why the Orange Book is searched far beyond pharmacy.
The electronic Orange Book on accessdata.fda.gov has product, applicant and patent searches; the full data set can be downloaded as monthly files.
Enter a proprietary name, an active ingredient or an application number in the main search box. The results list every approved product for that ingredient with its applicant, strength, marketing status and TE code.
Use the applicant field to pick one or several companies, and the dosage form and route fields (for example TABLET, ORAL) to separate products that share an ingredient.
From a product, open its patent and exclusivity information to see each listed patent number, its expiration date, whether it claims the drug substance, the drug product or a method of use, and each exclusivity code with its expiry.
Use Find Patent Information to search by patent number, and check the Newly Added Patents and Delisted Patents lists to see recent changes.
The products, patent and exclusivity tables are published as downloadable files, updated monthly, for analysis in a spreadsheet or database.
Where FDA lists patents or exclusivity, they appear on the drug's record in ClinicaLister with expiry dates, next to its approvals, label, NDC listings and safety summary.
The same molecule view shows its clinical trials through verified molecule–trial links, so you can read a listed exclusivity date alongside what the sponsor is still developing.
Products are tied to their UNII substance code, so the brand and its generics roll up to one molecule instead of separate names.
Through the ClinicaLister MCP server, an assistant can pull a drug's listed patents and exclusivity together with its trials and approvals in one answer.
Daily
sync of FDA's Orange Book file
1,200+
FDA drug records with listed patents
500+
FDA drug records with exclusivity periods
ClinicaLister loads the full Orange Book file daily. Patents attach to about 4% of its Drugs@FDA product records and exclusivity to about 2%, mostly brand-name products — enough for a per-drug lookup, not for a complete loss-of-exclusivity calendar. Counts measured August 2026.
It is FDA's list of approved drug products with therapeutic equivalence evaluations, formally titled Approved Drug Products with Therapeutic Equivalence Evaluations. It also lists the patents and exclusivity periods that apply to brand-name drugs.
A TE code starting with A means FDA considers the product therapeutically equivalent to its reference product; AB is the code for products where potential bioequivalence problems have been resolved with adequate evidence. Codes starting with B are not considered equivalent.
It shows listed patent and exclusivity expiry dates, which are the starting point. The real launch date also depends on patent challenges, litigation and settlements, which the Orange Book does not track.
FDA updates the downloadable Orange Book data files monthly. ClinicaLister checks the file daily, so updates appear soon after FDA publishes them.
See listed patents and exclusivity beside a drug's trials
Built for the Regulatory Affairs Specialist. See it in the product: Drug & Device Details. All data sources