Introduction
The Orange Book is a comprehensive list of drugs and pharmaceuticals that the U.S. Food and Drug Administration (FDA) has approved as both safe and effective. Its formal name is Approved Drug Products with Therapeutic Equivalence Evaluations. To make it into this prestigious list, a drug must demonstrate both safety and efficacy. Any drug whose approval has been withdrawn is excluded, while drugs undergoing current regulatory actions may still appear.
Key Insights
- The Orange Book is an accessible list maintained by the FDA detailing all pharmaceutical drugs certified as both safe and effective.
- Only drugs that have completed phase 3 clinical trials successfully are included in the list.
- It offers a valuable resource for identifying generic drug equivalents, often a more cost-effective option for patients.
Understanding the Orange Book
The FDA approves new drugs, or existing drugs for new uses, after a series of double-blind randomized clinical trials. Early stages focus on assessing a compound’s safety to ensure it does not cause severe side effects. Phase 3 trials evaluate both safety and efficacy on larger sample sizes. If these trials are successful, the drug is approved for use and included in the Orange Book.
Freely accessible online, the Orange Book allows easy searches for generic equivalents to brand-name drugs, drug patents, and data on drug exclusivity. Both healthcare professionals and consumers can utilize it to identify approved drug uses and the patent expiry dates for branded drugs.
To find a generic equivalent, such as for the antidepressant Prozac, you would search for its active ingredient, fluoxetine hydrochloride. Marketing and selling a generic drug requires the generic drug maker to file an Abbreviated New Drug Application (ANDA) with the FDA and proof that the drug is bioequivalent to the brand-name drug. If the ANDA is approved, the generic drug will appear in the Orange Book.
Practical Application: Using the Orange Book
For example, a search for the antidepressant Prozac reveals various forms (capsules, tablets, solutions, delayed-release pellets, etc.) and different dosage strengths. The search shows that five forms have been discontinued, but were not withdrawn for safety or efficacy reasons. Initially approved in 1987, the drug is validated for treating acute and treatment-resistant depression in adults.
The Orange Book illustrates the drug’s active ingredient, fluoxetine hydrochloride, which may be available generically at a lower cost.
Patent Information: Protecting Innovations
When a new drug hits the public market, the FDA awards a medical patent to the drug maker. Here are the varying types of exclusivities:
- Orphan drug patents last for seven years.
- New chemical entity exclusivity lasts for five years.
- New Clinical Investigation Exclusivity lasts three years.
- Pediatric Exclusivity (PED) adds six months to existing patents or exclusivities.
- Patent Challenge (PC) grants protection for 180 days (specific to ANDAs).
- Competitive Generic Therapy (CGT) also grants 180 days (specific to ANDAs).
Under the Hatch-Waxman Act, generic drug manufacturers must certify that they will not launch their product before the original patent expires. Available in PDF, print, and electronic formats, the Orange Book’s electronic version is the most current, featuring daily updates on generic approvals and patent information, while monthly updates cover new drug applications and discontinued products. Presently, new patent terms last 20 years from the patent application filing date in the U.S., though several factors can influence this duration.
Related Terms: Abbreviated New Drug Application, Clinical Trials, Bioequivalence, Drug Patents, Exclusivity Period.
References
- U.S. Food & Drug Administration. “Approved Drug Products With Therapeutic Equivalence Evaluations | Orange Book”.
- U.S. Food & Drug Administration. “Step 3: Clinical Research”.
- U.S. Food & Drug Administration. “Abbreviated New Drug Application (ANDA)”.
- U.S. Food & Drug Administration. “Prozac”, Page 1.
- U.S. Food & Drug Administration. “Approved Drug Products With Therapeutic Equivalence Evaluations”, Pages 3-197 and 3-198.
- U.S. Food & Drug Administration. “Frequently Asked Questions on Patents and Exclusivity”.
- U.S. Food & Drug Administration. “Hatch-Waxman Letters”.
- U.S. Food & Drug Administration. “Frequently Asked Questions on The Orange Book”.
