Orange Book Companion®


Why Should You Choose the Orange Book Companion®?
Samples of the Orange Book Companion That Subscribers Receive

The Orange Book Companion contains extensive patent and market exclusivity information for FDA-approved drugs. The Orange Book Companion combines information from eight different sources to provide the most comprehensive, easy-to-follow companion to FDA's Orange Book



Available Formats

The Orange Book Companion may be purchased in two different formats:

  • Online Subscription: $295 Members | $395 Non-Members
  • CD-ROM: $395 Members | $495 Non-Members

2004 Orange Book Companion Two-Volume Book Set
Copies of this set are still available. Please contact Customer Service at (800) 956-6293 or (202) 371-1420.



Monthly Updates

Free monthly updates are included with each annual subscription. You receive a new CD-ROM containing all information—not just an update, and monthly updates are made to the online version so subscribers stay up-to-date with constant changes. All versions of the Orange Book Companion provide:

  • The title of each patent
  • The type of subject matter covered by each patent (e.g., compound, composition, use, etc. We found nineteen different types!)
  • Highlighted extended patents for easy identification (makes it easy to see which patent the drug owner regards as the most relevant for his/her product)
  • The length of the extension for each patent
  • National Drug Code classifications (e.g., Ace Inhibitor, Antiviral, Beta Blocker, etc.) for all products that have been assigned them
  • Products that have a generic equivalent or have nonequivalent (but very similar) generic competition are identified with a "generic tag"
  • Full exclusivity and use code descriptions
  • Up to eleven monthly updates for the trade name list to keep you up-to-date
  • Actual orphan indication for products that have Orphan Drug exclusivity, rather than just the "ODE" code
  • The strength (mg, mg/ml, etc.) for each variation of a product
  • Each variation of a product is identified as being prescription (RX), over-the-counter (OTC), or discontinued (DISC)
  • A "What's New?" file each month describing any changes to patents and exclusivity since the previous month.


Why should you pay for a subscription to the Orange Book Companion when the FDA offers the Electronic Orange Book (EOB) for free?

The Orange Book Companion starts where the EOB leaves off and includes information from seven additional sources to save you time and money when doing Orange Book research.

This is a very cost-effective product. The Orange Book Companion gives me quick access to the data I need. — Jeffrey S. Boone, J.D., Assistant General Counsel, Patents and Trademarks Mallinckrodt, Inc.



Less Duplication

The Orange Book Companion has less duplication than any other publication because the different variations (strengths) of a product are combined together in a single table when the patent and exclusivity information for all of the variations is identical. Each list is formatted into easy-to-read, easy-to-follow tables.



Easier to Find What You Need

The Orange Book Companion provides an index of active compounds that are part of multi-ingredient products, making it easier to find a multi-ingredient product even if you only know the generic name of one of its ingredients. The Orange Book arranges multi-ingredient products alphabetically by the first ingredient; therefore, if you were looking for all the products that contain RITONAVIR, you would not find the combination of LOPINAVIR and RITONAVIR in the Orange Book unless you knew to look under "L" in addition to "R." The Orange Book Companion's index includes that combination under both "R" and "L."

Less Calculations

There is no longer a need to do a mental subtraction of six months from "PED" expiration dates to discover which exclusivity the pediatric extension applies to because pediatric extensions of exclusivity are rolled into the Orange Book Companion's listing for the actual exclusivity that was extended.



Up-to-Date Information

The Orange Book Companion publishes a "What's New?" file each month describing the patents and exclusivity changes since the previous month.


Samples of Files That Subscribers Receive



Terms and Conditions for the Orange Book Companion

By subscribing to the Orange Book Companion, you agree to the terms and conditions set
for this product by FDLI.