Orange Book: What it is and how it Works

What Is the Orange Book?

The Orange Book is a list of drugs and pharmaceuticals 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 Drugs whose safety or efficacy approval has been withdrawn are excluded from the Orange Book.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 FDA approves new drugs, or existing drugs for new uses, following a series of double-blind randomized clinical trials. Early phases of this process involve tests to judge the safety of a compound, to make sure it does not cause severe side effects or harm. Phase 3 trials are conducted on larger samples to prove both safety and efficacy against a placebo. If successful, the drug will be added to the Orange Book and approved for use.

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.

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.

Using the Orange Book

For example, a search for the prescription antidepressant drug Prozac shows that the drug is available in different forms (capsules, tablets, solutions, delayed-release pellets, etc.) and it is also available in varying dosage 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the drug have been discontinued, although in three instances it has been noted that the product was not discontinued or withdrawn for safety or efficacy reasons.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 capsules were first approved in 1987, and the drug is approved for acute treatment of treatment-resistant depression in adults.

The Orange Book also shows that the drug’s active ingredient is fluoxetine hydrochloride, which may be generically available at a lower cost.

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 last for seven years, while a new chemical entity exclusivity lasts for five years.

• New Clinical Investigation Exclusivity lasts for a period of 3 years.
• Pediatric Exclusivity (PED) lasts 6 months on top of any existing Patents or Exclusivity.
• A Patent Challenge (PC) gives protection of 180 days (this exclusivity is for ANDAs only).
• Competitive Generic Therapy (CGT) lasts for 180 days (this exclusivity is for ANDAs only).

Under the Hatch-Waxman Act, in order for a generic drug manufacturer to win approval, they must certify that they will not launch their 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 ad discontinued products.