It is obvious that a bio-pharma product manufacturer would always first look for the existence of any similar product in the market. If it is to deal from the Regulatory perspective, the concern would be to chalk out their developmental/promotional strategies error-free. To enable all the generic drugs and biologics manufacturers know more about the approved generic and biologic products, the United States Food and Drug Administration (USFDA) has introduced individual comprehensive repositories such as Purple Book and Orange Book. What exactly these books entail and what information does the USFDA provide through these books is always a discussion point. Let us learn more about them.

Purple Book

The Purple book is a list of biological products, including biosimilars and interchangeable biological products, approved or licensed by Food and Drugs Administration (FDA) under the Public Health Service Act (the PHS Act). Formally known as “Lists of Licensed Biological Products with Reference Product Exclusivity and Bio-similarity or Interchangeability Evaluations", the purpose of the purple book is:

  1. To assist users, understand if a biological product has been approved by FDA under the PHS Act with a reference product (already approved biological product)
  2. To help identify if there is any exclusivity for a given reference product

The Purple Book includes two lists of biologics. The first list includes biologics approved by the FDA's Center for Drug Evaluation and Research (CDER) and the second list includes biologics approved by the Center for Biologic Evaluation and Research (CBER). The book also includes the following information about the biologics:

  • BLA Number
  • Non-Proprietary Product Names
  • Proprietary Product Names
  • Date the Product was approved in the Market
  • Date of the first Licensure
  • Whether the Product is Biosimilar or Interchangeable
  • Reference Product with an Expiry Date
  • Whether the Product is withdrawn from the Market

Orange Book

The orange book is a list of generic drugs approved by FDA. Formally known as Approved Drug Products with Therapeutic Equivalence Evaluations, the orange book lists drugs which are not only safe but also effective for human use. The orange book is available in electronic format (Electronic Orange Book) to provide access to information, such as brand-name drugs, drug patents and drug exclusivity, related to all the generic drugs approved by FDA and is mostly updated on a daily basis. The orange book consists of four parts:

  1. Prescription drugs with therapeutic equivalence equation which have already been approved by FDA
  2. Over-the-counter drugs which have been approved and cannot be marketed without their respective NDAs and ANDAs
  3. Drug products which are approved under section 505 of the FD&C Act
  4. Drug products which, either, have never been marketed and are saved for other uses, such as exportation, military use, or have been discontinued from distribution

Though, the Purple Book is biologically very similar to the 'Orange Book', the difference lies in their enlistment of products. Combining the information of both the books, FDA can help users with a comprehensive outlook of approved generic drugs and biological products.

With an increased number of approvals of generic drugs, biologics and soon-to-be biologics, the orange and purple book can prove to be useful for successful market entry. Are you planning to market your generic or biologic product globally? Reach out to our experts @