Two-Volume Book Set
Interested? Please send email!
The Premium Patent & Exclusivity
Addendum for the FDA Orange Book
. . . since there is nothing like
the feel of a book in your hands! Great for the "Internet-challenged"
or for situations when an Internet connection is not available.
Also great if you just like to have a book to page through!
What's the Orange Book
Companion Two-Volume Book Set?
The Orange Book Companion
two-volume book set is an 800+ page reference containing highly enhanced
patent and exclusivity information for FDA-approved drugs. It combines
data from six different sources, so you do not need to look
at each source individually to get the full picture for a product.
The Orange Book Companion two-volume book set has the following features or information:
- four separate lists
of approved drugs, each sorted differently:
- 1) by tradename,
- 2) by generic
- 3) by NDA applicant
- 4) chronologically
by the next-to-expire patent for each product.
- the title of each
patent is listed
- the type of subject
matter covered by each patent is listed (e.g., compound, composition,
use, etc. We found nineteen
- extended patents
are highlighted for easy identification, so you can see which patent
the drug owner regards as the most relevant for their product. The
length of the extension for each patent is also shown.
- FDA's "Established Pharmaceutical Class" is provided for all products that have been assigned them.
- products that have a generic
equivalent or have non-equivalent (but very similar) generic competition
are identified with a "generic tag."
- up to eleven monthly
updates for the Tradename list are provided to purchasers via email, so each
year's edition stays up to date. See below for
- each list is formated
into easy-to-read tables. Download our samples
to see what they look like.
- includes the full
exclusivity and use code descriptions, so you do not have to look
them up in a separate list
- the NDA Applicant's
name is included for each product
- the strength (mg,
mg/ml, etc.) for each variation of a product is listed, so that you
can immediately see how Product 001 differs from Product 002, etc.
- the Companion
has less duplication, since 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 variation
of a product is identified as being prescription (RX), other-the-counter
(OTC), or discontinued (DISC)
- pediatric extensions
of exclusivity are rolled into the listing for the actual exclusivity
that was extended. So there is no more need to do a mental subtraction
of six months from "PED" expiration dates to discover which exclusivity
the pediatric extension applies to.
Samples of the 2002 Edition
Download a 2002 Edition
to see the wealth of
information that can be at your fingertips with a purchase of the
Orange Book Companion two-volume
Free Updates Each
The Orange Book Companion
two-volume book set will not get out of date as the months go by. Each
month, for the remainder of the Orange Book fiscal year for the
edition that was purchased (generally February through January), every
purchaser will receive an update to the Trademarks list in Adobe Acrobat (PDF) format for easy printing via email. This update
will have two parts:
who make their purchase after the beginning of an Orange Book year will
receive via email all the month-to-month updates that were published up
to that point in addition to the latest cumulative update. They will
then routinely be sent the monthly updates.
- the first will
show the changes from the previous month;
- the second will
show all the changes since the publication of that edition
of the Orange Book Companion two-volume book set.
We hope to open ordering soon! You can then try it
risk-free* for 30 days!
* If the Orange Book
Companion two-volume book set does not meet your needs, return it within 30 days
and receive a refund of your purchase price.
Please send your questions,
comments or suggestions relating to the Orange Book Companion
two-volume book set to:
to Orange Book Companion Home Page