By Kurt R. Karst –
There are several important dates in the history of the Orange Book – FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations – some of which are the result of advancements in technology, and some of which occur (curiously) around the end of October (and a couple on Halloween specifically). For example:
- May 31, 1978: This is the date that is probably most often associated with the conception of the Orange Book. It was on May 31, 1978 that FDA Commissioner Donald Kennedy, Ph.D., sent a letter to state officials informing them of FDA’s plans to develop a “master list to provide a guidance and information that could be utilized by each state in meeting its own responsibilities under the particulars of its drug product selection law.”
- June 30, 1978: On this date, FDA announced the availability of an “interim list” named the Approved Drug Products List.
- January 12, 1979: This is the date that is probably most often associated with the birth of the Orange Book (though it was not orange at that time). It was on this date that a publication titled Approved Drug Products with Proposed Therapeutic Equivalence Evaluations was first made publicly available by FDA.
- October 31, 1980 (Halloween): FDA published a final rule and made available the inaugural edition of the Approved Drug Products with Therapeutic Equivalence Evaluations and the first cumulative supplement of the publication.
- September 24, 1984: This is the date of enactment of the Hatch-Waxman Amendments, which amended the FDC Act to add Section 505(j)(6) (later moved to Section 505(j)(7)) requiring FDA to publish and make publicly available a list of approved drug products, including patent information.
- October 31, 1997 (Halloween): This is the date on which an electronic Orange Book search function was added to FDA’s website. (Beginning in 1998, current patent listings for approved drug products could be obtained from the electronic Orange Book through a search by active ingredient, proprietary name, application holder, or application number. Since February 2005 (25th edition), FDA has provided daily electronic Orange Book product updates, and made the volume available in a downloadable PDF format.)
- October 24, 2008: This is the date on which patent information was first listed in the Orange Book covering an old antibiotic drug product. The drug was MOXATAG (amoxicillin extended-release) Tablets, and the patents were U.S. Patent Nos. 6,544,555, 6,669,948, and 6,723,341. Patents for antibiotics were made listable with the October 8, 2008 enactment of Section 4 – “Incentives For The Development Of, And Access To, Certain Antibiotics” – of the “QI Program Supplemental Funding Act of 2008” (Pub. L. No. 110-379) (see our previous post here).
We now have a new date to add to the list: November 9, 2015. This is the date on which FDA released an app for the Orange Book (for both iOS and Android devices), called the Orange Book Express (or “OB Express” as it comes up in the Apple App Store). (We understand that the app was slated for release on Friday, October 30, 2015, but a couple of last minute changes delayed things by several days.)
We spent some time exploring the new Orange Book app. It’s a pretty impressive piece of technology, and one that we expect to use quite often. The format is easy to view and to understand!
The app's home screen (pictured below) allows users to search by Active Ingredient, Proprietary Name, Applicant Holder, Application Number, and Patent Number. Search results are displayed with tabs showing listings in the Prescription Drug Product List, the Over-the-Counter Drug Product List, and the Discontinued Drug Product List sections of the Orange Book. Each drug product listing links to the same patent and exclusivity information appearing in the paper and electronic versions of the Orange Book, and includes links defining patent use codes and exclusivity codes. You can even email FDA's Division of Drug Information directly from the app with questions. Also, built-in links on the app home page take you to lists of Newly Added Patents, Patent Delistings, and FDA's Orange Book website.
The OB Express App is a must-have for anyone practicing in the Hatch-Waxman space. You can bet the new app is on this blogger's iPhone home page. (Now how long will it take FDA to develop an app for the Purple Book?)