What Is the 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. Although it is commonly called the Orange Book, its formal name is Approved Drug Products with Therapeutic Equivalence Evaluations.

The Orange Book does not include drugs only approved as safe (they must also have been proven to be effective). Drugs whose safety or efficacy approval has been withdrawn are excluded from the Orange Book. However, a drug that is currently subject to regulatory action may still appear in the Orange Book.

Understanding the Orange Book

The Orange Book is available online for free. This makes it easy 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 different dosage forms (capsules, tablet, solution, delayed release pellets) and it is also available in varying strengths. This search also reveals that five forms of the drug have been discontinued, although in three instances it has been noted that the product was not discontinued or withdrawn for safety or efficacy reasons.

The Orange Book also shows that the drug’s active ingredient is fluoxetine hydrochloride. The capsules were first approved in 1987, and the drug is approved for acute treatment of treatment-resistant depression in adults.

Identifying a Generic Equivalent

A doctor or patient can see if there is a generic equivalent to a brand-name drug by doing an active ingredient search. For Prozac, you would search the Orange Book for “fluoxetine hydrochloride.” To be able to market and sell a generic drug, the generic drugmaker must file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). The drugmaker must prove that the drug is bioequivalent to the brand-name drug. If an Abbreviated New Drug Application (ANDA) is approved, the generic drug will be listed in the Orange Book.

Patent Information

When a new drug is introduced to the public, the Food and Drug Administration (FDA) awards the drugmaker a medical patent that protects the product from competitors for a given period of time. Orphan drug patents lasts for seven years, while new chemical entity exclusivity lasts for five years. Under the Hatch-Waxman Act, in order for a generic drug manufacturer to win approval, they must certify that they will not launch its generic product until after the expiration of the patent.

The Orange Book is available as a PDF, in print and electronically. The electronic version of the Orange Book is the most up-to-date because there are updates made daily, including generic drug approvals and patent information. Other information may only be updated monthly, such as new drug application approvals and discontinued products.