Officially known as Approved Therapeutic Equivalence Assessment Drugs, the FDA Orange Book contains a list of drugs that the FDA has determined to be effective and safe. It contains not only safe or approved drugs, but also a list of drugs that have been withdrawn for efficacy or safety.
In addition, these drugs, which are subject to regulatory action, will continue to be included in the Orange Book. If you want to know more about orange book, then you may opt for Wizmed.
What are the main advantages of Orange Book?
Orange Book makes it easy for drug manufacturers to keep track of new generic drugs that come on the market and violate their own patents. As a result, companies with FDA-approved drug patents can easily tell if a new generic version is being manufactured and sold.
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Consumers, doctors and drug manufacturers can see the expiration date of drug patents, as well as other important details or market exclusions.
Orange Book also highlights patent filing dates so that anyone can easily tell when the drug was filed for patent protection, in addition to the date the patent went into effect. However, this information is available for drugs that have been patented since 2013. For drugs patented before 2013, parties must contact the FDA for the exact date of filing the patent.
Patent filing dates help generic drug manufacturers find out if they can legally produce and sell generic versions of drugs. It also helps them find out if a drug patent has passed 30 months since it was enforced.