FDA Orange Book (Last Edition) – Free PDF Download






Officially known as Approved Drug Products With Therapeutic Equivalence Evaluations, the FDA Orange Book contains a list of drugs considered by the FDA as both effective and safe. It does not only contain drugs that are safe or approved, but also has a list of drugs whose efficacy or safety approval has been withdrawn. In addition, a drug that is being subjected to regulatory action will still be present in the Orange Book.

What Are The Key Benefits of the Orange Book?

  • The Orange Book makes it easy for drug manufacturers to keep an eye on new generic medications that hit the market and infringe on their own patents. As a result, such businesses with patents on drugs that are approved by the FDA can easily find out if new generic versions are being made and sold.
  • Consumers, doctors and drug manufacturers can view the expiration date of a drug patent and any other important details or market exclusivities.
  • The Orange Book also highlights patent submission dates, so anyone can easily know when the drug was submitted for patent protection besides the date when the patent becomes effective. However, this information is available for drugs that got patents on or after 2013. For drugs patented before 2013, parties need to reach out to the FDA for precise patent submission dates.
  • The patent submission date helps generic drug manufacturers know whether they can legally create and sell generic versions of a given drug. It also helps them to see whether the drug patent has passed the 30 month-mark ever since it became effective.

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