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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-16959, Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.
2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.
2026-16939, GNT USA, LLC.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.
Previous / Next Documents
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.
Next: 2026-03851, Determination of Regulatory Review Period for Purposes of Patent Extension; TEVIMBRA
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.