TEVIMBRA's Patent Gets FDA Time-Stamp Approval
Published Date: 2/26/2026
Notice
Summary
The FDA has officially set the review period for TEVIMBRA, a human biological product, which helps the company extend its patent protection. This means the patent clock can be paused, giving the maker more time to benefit from their invention. If anyone thinks the dates are wrong or wants to challenge the company’s effort during review, they must act by April 27 or August 25, 2026.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
FDA Sets TEVIMBRA Review Period
The FDA determined the regulatory review period for TEVIMBRA (tislelizumab-jsgr) is 2,997 days in total. That total includes a 2,021-day testing phase and a 976-day approval phase; key dates are: testing began December 31, 2015, the biologics license application was submitted July 12, 2021, and the application was approved March 13, 2024.
Applicant Seeks 1,987-Day Extension
The company applying for patent extension (BeiGene Switzerland GmbH) seeks 1,987 days of patent term extension for U.S. Patent No. 8,735,553 covering TEVIMBRA. The notice explains that this FDA determination establishes the maximum potential length, but the U.S. Patent and Trademark Office (USPTO) will apply statutory limitations when calculating the actual extension.
Deadlines To Challenge Dates and Due Diligence
Anyone who believes the published dates are incorrect may request a redetermination by April 27, 2026. Any interested person may petition FDA about whether the applicant acted with due diligence during the regulatory review period by August 25, 2026, following the petition requirements in 21 CFR 60.30.
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Key Dates
Department and Agencies
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