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.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Take It Personal
Get Your Personalized Policy View
Start a Free Government Policy Watch to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in