ZIIHERA Drug Patent Review Period Locked In by FDA
Published Date: 4/3/2026
Notice
Summary
The FDA has set the official review period for the drug ZIIHERA, which helps the company extend its patent protection. This affects the patent holder and anyone interested in the drug’s approval timeline. If you think the dates are wrong or want to challenge the company’s review speed, you have until June 2 or September 30, 2026, to speak up—potentially impacting how long the patent lasts and when generics can enter the market.
No Economic Impacts Identified for this Document
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
2026-09767, Oscar Bobo: Final Debarment Order
Oscar Bobo is officially banned for 5 years from importing any drugs into the U.S. because he repeatedly brought in mislabeled medicines that don’t follow FDA rules. He didn’t respond to the FDA’s warning, so the ban started on May 15, 2026. If he wants to end the ban early, he can apply anytime, but must follow special rules to keep his info private.
2026-09533, Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information
The FDA wants your help to improve tests that spot kidney damage caused by medicines. They’re asking researchers, doctors, and companies to share data by July 13, 2026, so they can make these kidney safety markers better and faster. This could lead to safer drugs and smarter health checks, benefiting patients and the medical community alike.
2026-09508, Azodicarbonamide (ADA); Request for Information
The FDA is asking for info about azodicarbonamide (ADA), a chemical used in some foods and food packaging, to check if it’s still safe. Food makers, scientists, and anyone with data should share what they know by July 13, 2026. This review could lead to changes in how ADA is used, affecting food companies and possibly costs down the line.
2026-09543, Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
The FDA wants your thoughts on how drug companies report problems after their products hit the market. This update affects drug makers and helps keep medicine safe by improving how side effects are tracked. You’ve got until July 13, 2026, to share your comments—no cost to join, just your voice!
2026-09544, Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc.
The FDA is inviting the public to comment on the renewal of special approval for two cigarette products by 22nd Century Group Inc. These products claim to lower health risks compared to regular cigarettes. If renewed, the company can keep marketing them this way, with the comment period starting May 13, 2026.
2026-09507, Butylated Hydroxytoluene (BHT); Request for Information
The FDA wants to know more about how butylated hydroxytoluene (BHT), a chemical used in food and food packaging, is being used and if it’s still safe. They’re asking companies, scientists, and the public to share any info by July 13, 2026. This could lead to changes in rules that affect food makers and might impact what’s allowed in your snacks and packaging.
Previous / Next Documents
Previous: 2026-06475, Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To Amend Cboe Rule 5.4
Cboe Exchange is changing the smallest price step for options on its Mini Bitcoin ETF Index to make trading smoother and clearer. This change affects traders using these options and kicks in quickly after approval, with no extra costs involved. The SEC gave this update a fast green light, so expect the new rules to start soon!
Next: 2026-06477, Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO
The FDA has officially set the review period for ENCELTO, a medicine patent, so the company can apply to extend its patent protection. This affects the drug maker and anyone tracking patent timelines, with deadlines to challenge dates or diligence claims coming up in June and September 2026. It’s a key step that could mean more time before generic versions hit the market, impacting money and medicine availability.