FDA Sets Patent Review Period for Drug ROLVEDON
Published Date: 6/16/2025
Notice
Summary
The FDA has officially set the review period for ROLVEDON, a new medicine, so its patent can be extended. This helps the company protect their invention longer, giving them more time to make money before generics show up. If anyone thinks the dates are wrong or wants to challenge the company’s effort during review, they must speak up by August 15 or December 15, 2025.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA sets ROLVEDON review period and dates
FDA determined the regulatory review period for ROLVEDON is 4,720 days in total — 3,668 days in the testing phase and 1,052 days in the approval phase. FDA cites the investigational new drug (IND) effective date as October 9, 2009; the biologics license application (BLA) submission date as October 24, 2019; and the approval date as September 9, 2022. In its patent extension filing the applicant seeks 325 days of patent term extension.
Deadlines to challenge dates or applicant diligence
Anyone who knows any of the published dates are incorrect can submit comments and ask for a redetermination by August 15, 2025 (submit electronically at https://www.regulations.gov). Any interested person may petition FDA about whether the applicant acted with due diligence during the regulatory review period by December 15, 2025, following the procedures in 21 CFR 60.30 and 21 CFR 10.20.
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