The Mac-Stacks Emporium today announced that it has created a web site that contains all of the patent and exclusivity information from the U.S. Food and Drug Administrationis so-called "Orange Book" in an easy-to-use tabular format.
What is the FDAis Orange Book?
Officially titled "Approved Drug Products with Therapeutic Equivalence Evaluations," the Orange Book lists every drug that has been approved for use in humans by the FDA. An addendum to the Orange Book contains information about the unexpired patents and market exclusivities that cover some of the listed drugs. However, up to now, a convenient web-based version of the patent and exclusivity addendum has not been available.
What is the Orange Book Unleashed web site?
The Orange Book Unleashed web site (located at http://home.earthlink.net/~mac_stacks) contains the patent and exclusivity addendum information from the Orange Book in 26 easy-to-use tables (one for each letter of the alphabet). The 26 HTML files that contain these tables were created by the single click of a button in a HyperCard stack that caused a script to operate on three data files from the FDA. The HyperCard script correlated patent information from the first file with exclusivity information from the second file with the product information contained in the third file. The script then created the 26 web pages with the products being sorted alphabetically by trademark. Each table contains the product, patent and exclusivity information in an easily readable format with products and variations of products distinguished from each other by an alternating gray and white background.
What makes these web pages even more useful are the hypertext links that the HyperCard script automatically generated. The New Drug Application ("NDA") number for each product is linked to the information for that product in the FDAis "Electronic Orange Book," so you can easily go there if you need further information about the product, such as its manufacturer and approval date(s). Each the patent number is linked to the full text of that patent on the Internet site of the U.S. Patent and Trademark Office ("PTO"). Further, all of the Use Codes and Exclusivity Codes in each table are linked directly to their definitions in the Orange Bookis definition list, so you do not have to scroll through the list looking for the definition that you are interested in.
You are invited to stop by the Orange Book Unleashed web site to see what the single click of a HyperCard button can do. An example of one record from each of the three FDA data files is provided so that you may compare them with the resulting tables. The site will be updated whenever the FDA updates its data files.
You can find more information at the Mac-Stacks Emporium Web site.