FDA Updates Orange Book With Patent Submission Dates
As part of efforts to increase transparency and generic drug competition, the US Food and Drug Administration (FDA) is publishing patent submission dates to help generic drug manufacturers determine the earliest date when they may be able to market new generics.
FDA began collecting the patent submission date data in 2013, and the agency says there are about 4,000 patent records for which submission dates are available.
The update is the result of a final rule from October 2016, known as "Abbreviated New Drug Applications and 505(b)(2) Applications," and FDA says the Orange Book will now publish patent submission dates for all new records going forward.
But will the disclosure of these patent submission dates, which are the dates on which FDA receives patent information from the new drug application (NDA) holder, have an impact on increasing generic competition?
Bernstein analyst Ronny Gal told Focus: "I think this is a very minor change, relating to the odd case" where there is a question if a generic company filed an ANDA before or after specific patents were listed.
FDA noted that NDA holders can email error correction requests, including justifications for the requests, to [email protected]. "Requests will be considered on a case by case basis and, if accurate, will be updated in the Orange Book as soon as is practicable," FDA said.
FDA introduces patent submission date updates to the Orange Book