What is the Orange Book?
The Orange Book is a list of drugs that the United States Food and Drug Administration (FDA) has approved as safe and effective. Although it is commonly called the Orange Book, its official name is Approved Pharmaceuticals with Therapeutic Equivalence Assessments.
The Orange Book does not include drugs only approved as safe (they must also have proven their effectiveness). Drugs whose safety or efficacy has been withdrawn are excluded from the Orange Book. However, a drug which is currently the subject of regulatory action may still appear in the Orange Book.
Understanding the orange book
The Orange Book is available online for free. This allows healthcare professionals to easily search for generic equivalents to brand name drugs, drug patents and drug exclusivity. Consumers can also access the Orange Book online. Patients and doctors can see approved drug uses and patent expiration dates for brand name drugs.
For example, research on the prescription antidepressant medication Prozac shows that the medication is available in different dosage forms (capsules, tablets, solutions, delayed-release tablets) and that it is also available in different strengths. This research also reveals that five forms of the drug have been discontinued, although in three cases it has been noted that the product has not been stopped or withdrawn for safety or efficacy reasons.
The orange book also shows that the active ingredient in the drug is fluoxetine hydrochloride. The capsules were first approved in 1987 and the drug is approved for the acute treatment of treatment-resistant depression in adults.
Identify a generic equivalent
A doctor or patient can see if there is a generic equivalent to a brand-name drug by researching an active ingredient. For Prozac, you would do a search in the orange book for “fluoxetine hydrochloride”. To be able to market and sell a generic drug, the generic drug manufacturer must file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). The pharmacist 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.
When a new drug is released to the public, the Food and Drug Administration (FDA) grants the drug manufacturer a medical patent that protects the product from competitors for a specified period of time. Patents on orphan drugs last seven years, while the exclusivity of a new chemical entity lasts five years. Under the Hatch-Waxman Act, for a generic drug manufacturer to obtain approval, it must certify that it will not launch its generic product until the patent has expired.
The Orange Book is available in PDF, printed and electronic format. The electronic version of the Orange Book is the most recent, as updates are made daily, including approval of generic drugs and patent information. Other information can only be updated monthly, such as the approval of new drug requests and discontinued products.