Orange Book Companion2017-11-28T13:26:04+00:00

Orange Book Companion®

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.

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  • +$100 for Nonmembers

Available Formats

The Orange Book Companion may be purchased as an online subscription.

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

Monthly Updates

Free monthly updates are included with each annual subscription. Monthly updates are made to the online version so subscribers stay up-to-date with constant changes. Orange Book Companion provides:

  • 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.”

Fewer 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.

Terms and Conditions for the Orange Book Companion

Payments are non-refundable unless it becomes impossible for FDLI to access, extract, and reproduce data and information from FDA’s electronic Orange Book files. In such case, FDLI will inform the Subscriber of this situation and a pro-rated refund for the number of months remaining in the subscription may be requested.

Online subscriptions will start the day after FDLI sends the user ID and password to the Subscriber Contact Person*. Every employee and contract worker in Subscriber’s organization who has authorization from the Subscriber to the Subscriber’s Intranet system is eligible to use the account. Any such eligible person may access the account from any web-connected computer, whether from home using his/her own Internet service or while traveling.

The Online subscription account information (user ID and password) may not be shared outside the Subscriber’s organization. Employees of affiliated organizations that share a common Intranet with the Subscriber may also use the account. If an affiliated organization does not share a common Intranet with the Subscriber, that affiliated organization must purchase a separate subscription.

A CD-ROM subscription will start with the current FDA Orange Book supplement. CD-ROMs will be mailed First Class to the Subscriber Contact Person each month. A “base” subscription entitles the Subscriber to copy the contents of the CD-ROM to a single Intranet server. The “base” subscription and any “additional” subscriptions entitle each recipient of a CD-ROM to copy the contents of that CD-ROM to the hard drive of a single computer. Neither the CD-ROM nor its contents may be duplicated or distributed.

The Subscriber is totally responsible for making the CD-ROM files available over the Subscriber’s Intranet or copying the files to a computer hard drive. Each CD-ROM contains a Home Page (index.htm) that has links to the data files.

Any act on the part of the Subscriber, its agents, or employees capable of causing the Online or CD-ROM files to be available to the public is strictly prohibited, and will result in the cancellation of the subscription without refund. The arrangement and presentation of data in the data files are protected by copyright. FDLI reserves the right to take any action to which FDLI is entitled by law, in addition to cancellation of the subscription, for the unauthorized distribution of any of the files.

Warranty Disclaimer

By using the Orange Book Companion files that are provided under a subscription, the Subscriber expressly acknowledges and agrees that the use of the files is at the Subscriber’s own risk. The files are provided “as is.” There is no warranty, expressed or implied, including any warranty of merchantability or fitness for a particular purpose. There is no warranty that the files will be error free.

Limitation of Liability

Under no circumstances, including negligence, shall FDLI be liable for any incidental, special, or consequential damages that result from the use or inability to use the files, even if FDLI has been advised of the possibility of such damages. In no event shall FDLI’s total liability to the Subscriber or to any third party exceed the amount paid for the annual subscription for the year in question.

* “Subscriber Contact Person” is the specific individual who placed the subscription order.