The U.S. Food and Drug Administration (FDA) recently updated the Orange Book to include patent submission dates. A patent submission date is the date the FDA receives patent information from the NDA holder. For each patent that claims a drug substance (active ingredient), drug product (formulation and composition), or method of use, the FDA requires all NDA applicants to submit the detailed patent information provided for under on 21CFR314.53. Now, the dates of these submissions are being recorded and published by the FDA.
Currently the FDA has about 4,000 patent records with submission dates dating back to 2013. Going forward, all new submission dates will be published. This new information will help clarify whether a patent was late-listed, relisted, or properly listed, along with others issues faced by generic drug companies. An ANDA applicant will now be able to determine with greater certainty whether listed patents require certification since a company with a pending ANDA is not required to certify to new patent information listed in the Orange Book more than 30 days after patent issuance, or more than 30 days after a relevant approval under an NDA making a previously issued patent listable. These dates will also help determine whether a listed patent will trigger a 30-month stay, delay approval of a pending application, or require some other strategy.