DEFINITION of Orange Book
The Orange Book is a list of drugs that the U.S. Food and Drug Administration (FDA) has approved as both safe and effective. Formally called Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book does not include drugs only approved as safe. Drugs whose safety or efficacy approval has been withdrawn are also excluded from the Orange Book. Furthermore, a drug that is currently subject to regulatory action may still appear in the Orange Book.
BREAKING DOWN Orange Book
The Orange Book is available online for free, making it easier for medical professionals to search for generic equivalents to brand-name drugs, drug patents and drug exclusivity. Consumers can also access the Orange Book online. Both patients and doctors can see approved uses for drugs and patent expiration dates for name-brand drugs. For example, a search for the prescription antidepressant drug Prozac shows that the drug is available in four dosage forms of varying strengths, all of which are in the form of capsules taken orally. The Orange Book also shows that the drug’s active ingredient is fluoxetine hydrochloride; that one version of the capsule only needs to be taken weekly; that the capsules were first approved in 1987; that the drug is approved for acute treatment of treatment-resistant depression in adults; and that the patent on some forms of the drug expires in November 2017.
A doctor or patient can then see if there is a generic equivalent to a brand-name drug by doing an active ingredient search. For example, for Prozac, one would search the Orange Book for “fluoxetine hydrochloride” to learn that more than a dozen companies produce a generic version of this drug. To be able to market and sell a generic drug, the generic drugmaker must file an Abbreviated New Drug Application (ANDA) with the Food & Drug Administration (FDA), which requires that the drugmaker prove that the drug is bioequivalent to the brand-name drug. If an ANDA is approved, the generic drug will be listed in the Orange Book.
When a new drug is introduced to the public, the FDA awards the drugmaker a medical patent which protects the product from competitors for a given period of time, usually 20 years. Orphan drug exclusivity lasts for seven years, while new chemical entity exclusivity lasts for five years. The patents are listed in the Orange Book. In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must certify that it will not launch its generic product - until after the expiration of the patent; unless the patent is found to be invalid or unenforceable or; if the generic product will not infringe the listed patent.
The electronic versions of the Orange Book are the most up-to-date, since some information is updated there daily. Generic drug approvals and patent information, for example, are updated daily. Other information may only be updated monthly, such as new drug application approvals and discontinued products. The Orange Book is also available in PDF and print versions.