The Orange Book : Your Key To Generic Drug Approvals And Patent Information

Every new drug that's sold in the United States has to go through some form of governmental approval with the Food & Drug administration. This process can range from :

• detailed clinical trials for brand new drugs to demonstrate effectiveness and safety.
• to new uses of existing drugs that have already been proven safe.
• to new processes to generate drugs that have similar or identical active ingredients via bioequivalence studies.

A lot of drug manufacturers specialize in bringing generic versions of drugs into the market after navigating the information on patents and exclusivity periods.

That information in the Orange Book is made publicly available in electronic format by the FDA. It was published with an orange cover when it was available in print edition, hence the name. The information is available in an online database as the “Electronic Orange Book” or published in pdf format. The online database is updated daily as new generic drug approvals occur. The pdf version is published annually with monthly Cumulative Supplements.

The primary use of the Orange Book for medical professionals is to find alternative drugs to treat existing symptoms, often at the behest of patients looking to save money. For drug companies, the Orange Book is the first place to look for possible conflicts with patents.

The Electronic Orange Book can be searched...
• active ingredient,
• proprietary name,
• application number,
• application holder, and
• patent.

This database is critical to your FDA approval process because it gives you information on what effective therapies are out there for existing conditions. Knowing about the competition is an important consideration when creating a new product to compete in that space.

Because the Orange Book database contains information on :
• patent applications and expiration dates.
• as well as exclusivity time lines.

You can also evaluate whether a competing product is about to 'go generic', which can influence marketing considerations whether or not to bring your drug to market.

FDA also provides a therapeutic assessment for approved FDA medications in the Orange Book database.

The vast majority of research in the Orange Book focuses on finding competing drugs with the same (or similar) active ingredients. Much existing pharmaceutical research comes not from discovering new compounds, but from trying to improve our understanding of the ways existing compounds work. This leads to incremental improvements in therapies; getting a better set of data on how a given dosage of an active ingredient behaves when used to treat a specific disease. The Orange Book represents a simple searchable way to find out about prior art, which is critical in making a successful patent application.

Even drugs that aren't under patent consideration should be cross checked against the Orange Book; they can help you navigate questions of exclusivity and proven effectiveness, which is critical for getting a generic drug approval done. The first step in any kind of generic FDA drug approval process is a deep search into the Orange Book database to find out about prior art.

While the Orange Book has information on patents and a general effectiveness description for many products, it's only the tip of the iceberg. Every drug in the Orange Book has a more detailed write-up on file with the FDA, including the raw data sets from the clinical trials and preclinical trial stages, and all of that information can be requested. Much of it will never be released by FDA, but many times very valuable information can be obtained.

The next step in your drug approval process is to obtain the releasable information. This can be done by checking Drug@FDA to see if the information is available online. If the information is not available online, a request the information may be submitted directly to FDA or through one of the for-hire information companies. Depending on the product, the for-hire information company may already have a copy of the information in its files.

Getting a drug approved by the FDA is a long haul process, and it involves a lot of research above and beyond what's done in the lab. Having someone who's familiar with the Orange Book, or who's familiar with the entire end to end process is a great asset to pharmaceutical development companies.

You can always contact us here at Regulatory Affairs Associates at 248 747 8008 to discuss how we can help you. Or email us at info@regaffairs.net