TRYNGOLZA Drug Patent Extension Dates Finalized
Published Date: 2/26/2026
Notice
Summary
The FDA has officially set the review period for the drug TRYNGOLZA, which helps the company extend its patent protection. This means the drug maker could get extra time to keep their invention exclusive, potentially affecting competition and market prices. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by April 27 or August 25, 2026.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
FDA sets TRYNGOLZA review period
FDA determined TRYNGOLZA had a regulatory review period of 2,534 days (testing phase 2,289 days; approval phase 245 days). The agency verified key dates: IND effective January 13, 2018; NDA submitted April 19, 2024; NDA approved December 19, 2024. This determination establishes the maximum potential length of a patent extension for U.S. Patent No. 9,163,239 and could allow the company extra exclusivity that may affect competition and drug prices.
Company requests 1,390‑day extension
Ionis Pharmaceuticals has applied for patent term restoration for U.S. Patent No. 9,163,239 and is seeking 1,390 days of patent extension. If granted, 1,390 days would add roughly 3.8 years of additional exclusivity to the patent term.
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Key Dates
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Previous: 2026-03849 — Determination of Regulatory Review Period for Purposes of Patent Extension; AEROPACE
The FDA has set the official review period for the medical device AEROPACE, which helps the company extend its patent protection. This means the company could get more time to keep exclusive rights to their invention, potentially affecting competitors and consumers. If anyone thinks the dates are wrong or the company wasn’t careful during the review, they can speak up by April 27 or August 25, 2026.
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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.