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# FDA Adds Patent Submission Dates to Orange Book
- URL: https://www.fdaweb.com/fda-adds-patent-submission-dates-to-orange-book/
- Published: 2017-11-28T12:00:00.000Z
- Updated: 2026-09-14T23:03:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140215

FDA says it is including patent submission dates in the *Orange Book* prospectively. FDA began patent submission date data collection in 2013 and the latest *Orange Book* contains patent submission dates since then, according to attorneys **Sara Koblitz** and **Kurt Karst** (Hyman, Phelps & McNamara) in a *FDA Law Blog* [post](Well,%20This%20is%20).

“This is a big and important change to the *Orange Book*,” the attorneys write. “Now applicants will have a much clearer picture on timely listed patents and whether listed patents require certification. Knowing the submission date will also help clarify whether a listed patent will trigger a 30-month patent litigation stay, otherwise delay approval of a pending application, or require a carve-out.”

Previously, according to the post, patent submission date information was available only by contacting the *Orange Book* staff, making it difficult for generic companies to determine if a patent was late-listed, relisted, or properly listed, and therefore difficult to know whether an ANDA applicant needed to include a patent certification or needed to update an application with an amended certification.