HOST: Captain Mary Kremzner
PHARMACIST: Lieutenant Lindsay Davison
Captain Kremzner: The Orange Book has long been a reliable resource for information about FDA-approved drugs. The electronic availability of the Orange Book brings this valuable tool to the web for healthcare professionals.
Hi, I’m Captain Mary Kremzner and this is Drug Info Rounds, brought to you by the pharmacists in the FDA’s Division of Drug Information.
I spoke with FDA pharmacist, Lieutenant Lindsay Davison to talk about the Electronic Orange Book and how to use it to search for generic equivalents, patents, and exclusivity.
First, we’d like to provide a little bit of background on the Orange Book. Lindsay, can you summarize how it has been used by healthcare professionals over the years?
Lieutenant Davison: Sure. First I always like to clarify that the actual title of the Orange Book is Approved Drug Products with Therapeutic Equivalence Evaluations. This can be confusing.
As many healthcare professionals already know, the hard copy version of the book is orange—hence the user-friendly nickname. The printed version is available from the Government Printing Office in hardcopy or may be downloaded in full as a PDF version that is updated monthly.
As you know, healthcare professionals frequently call us at the FDA on behalf of their patients to find out when drugs were approved or when patents or exclusivity are going to expire, paving the way for generic drug approvals.
The Electronic Orange Book puts all that information at their fingertips, giving them instant access to answers and saving them a call.
Captain Kremzner: Generics are an obvious topic of interest for consumers and pharmacists. Can you demonstrate how they find out if generic equivalents exist for brand-name drugs?
Lieutenant Davison: Absolutely. This is the Orange Book’s home page. There are five search options available right on the home page. The most useful options allow a search by active ingredient or proprietary brand name.
I could search for any FDA approved product in the Electronic Orange Book. As an example, I’ll search for a product called Brilinta—a blood-thinning drug approved in 2011.
Brilinta is the brand-name so we will search by proprietary name.
So I enter Brilinta and hit search for prescription drug products… we get one result for the ticagrelor 90 milligram tablets by AstraZeneca.
The really easy part is that we can already tell from this screen that there are no generic equivalents approved, because the column titled “TE Code”, which stands for “Therapeutic Equivalence Code” is blank.
Captain Kremzner: One question I know we get a lot as follow up to this page is how pharmacists and patients can tell when a generic might become available for Brilinta in the future; can you speak to this?
Lieutenant Davison: Yes. Nobody can really predict the exact date that a generic product may come on the market, but the patent and exclusivity expiration dates can provide a rough estimate.
To find patent and exclusivity information, click on the hyperlinked Application Number. This opens a new page. The “View” option at the bottom shows us all the patents and exclusivity for Brilinta. We can see the exclusivity expiration date is July 20th, 2016, and the patent expiration dates run from July 15th, 2018 to July 9th, 2021. This range of patents and exclusivity is the reason we can’t predict the exact date a generic product might come on the market. Sometimes generics may even be approved prior to expiration of all patents and exclusivities.
Captain Kremzner: Let’s do a search for a product by a brand name that already has a generic equivalent.
Lieutenant Davison: Sure. Let’s use Zocor as an example, a popular brand name drug with multiple generics. If we enter “Zocor” into the proprietary name search, we get five results with the same application number. And since “AB” is listed under the TE Code column, we can already tell that there are generic products available. Drug products that FDA considers to be therapeutically equivalent are designated with the first letter “A” and another second letter based on the dosage form. “AB” therefore tells you that therapeutically equivalent generic products are available for the brand name product.
The active ingredient simvastatin is listed here, so we can go back to the home page and run a new search by active ingredient to find a listing of all generic manufacturers and approval dates.
So within just a few seconds, pharmacists and other healthcare professionals can let their patients know about generic drug alternatives that could save them money. It’s a very intuitive resource.
Captain Kremzner: Anything that makes this type of information faster to find is a great asset. If you have questions about the FDA’s Electronic Orange Book, call or email the FDA’s Division of Drug Information.