Unlocking the Secrets of FDA's Orange Book: An Introduction to Therapeutic Equivalence, Drug Patents & Exclusivities
The FDA’s Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, was introduced in 1979, and since its introduction has unquestionably been the authoritative reference source for drug products approved by FDA under the Federal Food, Drug & Cosmetic Act. No longer a printed book, but a database available on FDA’s website, the Orange Book lists all products that have been approved by FDA for safety and effectiveness, and explains the therapeutic equivalence code for multi-source products.
On February 13, David Rosen, a partner and co-chair of Foley’s Life Sciences Industry Team will present to anyone responsible for, or affected by, FDA pharmaceutical regulations a more thorough understanding and appreciation of the Orange Book.
Topics that will be covered include:
- Why and when FDA’s Orange Book was developed
- How to find product information
- What patent information can be listed
- Controversies about listing and delisting patents
- How and when the Orange Book is updated and how to correct inaccurate information
- The meaning of Therapeutic Equivalence codes and how they are used by state Boards of Pharmacy and Pharmacists
- The various types of exclusivity and their impact on product approval
- Practical tips for using this information in product development and approval
Key takeaways include:
- How to easily navigate and understand the contents of the FDA’s Orange Book
- Why the book is Orange
- How to mine the Orange Book for the information you need in developing and protecting products
- What to do if you suspect Orange Book information is inaccurate
- Why and when patent information is included in product records
- How to interpret marketing exclusivity information
- Why it is important to monitor the Orange Book regularly
- How the drug approval process and the Orange Book interrelate
