FDA Clocks ORLYNVAH Review for Patent Perks: Business as Usual
Published Date: 2/26/2026
Notice
Summary
The FDA has set the official review period for ORLYNVAH, a human drug, which helps decide how long its patent can be extended. This affects the drug’s maker by potentially giving them more time to protect their invention and earn money. If anyone thinks the dates are wrong or wants to challenge the company’s effort during review, they have until April 27 or August 25, 2026, to speak up.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
ORLYNVAH Review Period Set at 3,131 Days
The FDA determined the regulatory review period for the drug ORLYNVAH is 3,131 days total — 1,700 days in the testing phase and 1,431 days in the approval phase. The dates underlying this determination are: IND effective April 1, 2016; NDA initially submitted November 25, 2020; NDA approved October 25, 2024. This determination establishes the maximum potential length of any patent term extension the company may receive.
Deadlines To Challenge Dates or Diligence
Anyone who believes the published dates are incorrect may request a redetermination by April 27, 2026, and any interested person may petition FDA about whether the applicant acted with due diligence by August 25, 2026. Petitions must follow the procedures in 21 CFR 60.24 and 21 CFR 60.30 and be submitted electronically or in writing as described in the notice.
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
Related Federal Register Documents
2026-06478 — Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY
The FDA has officially set the review period for VYLOY, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind VYLOY, giving them a chance to extend their patent protection and potentially boost profits. If anyone thinks the dates are wrong or wants to challenge the company’s review speed, they must act by June 2 or September 30, 2026.
2026-06481 — Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI
The FDA has set the official review period for HYMPAVZI, a new human biological product, so its patent holder can apply for extra patent time. This affects the company behind HYMPAVZI and anyone interested in patent extensions. If you think the dates are wrong or want to challenge the company’s diligence, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.
2026-06480 — Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
The FDA has officially set the review period for EMRELIS, a medicine patent, so the patent owner can apply for extra protection time. If anyone thinks the dates are wrong, they have until June 2, 2026, to speak up. Also, people can challenge whether the patent owner was diligent during the review by September 30, 2026. This affects patent holders and could impact how long they keep exclusive rights to their product.
2026-06479 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA
The FDA has set the official review period for ENFLONSIA, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind ENFLONSIA and anyone interested in patent rules. 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 patent length and market exclusivity.
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 by potentially giving them more time to exclusively sell ENCELTO, which can mean more money. If anyone thinks the dates are wrong or the company wasn’t diligent, they have until June 2 or September 30, 2026, to speak up.
2026-06483 — Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER
The FDA has officially set the review period for INJECTAFER, a drug patent up for extension. This means the company can apply to extend their patent protection, potentially keeping their exclusive rights longer and impacting competition and pricing. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by June 2 or September 30, 2026.
Previous / Next Documents
Previous: 2026-03847 — Determination of Regulatory Review Period for Purposes of Patent Extension; REVUFORJ
The FDA has set the official review period for the drug REVUFORJ, which helps the company extend its patent and protect their invention longer. This affects the drug maker and anyone tracking patent timelines, with deadlines to challenge or comment by April 27 and August 25, 2026. It’s a key step in making sure the patent extension process is fair and on schedule, potentially impacting when generic versions can enter the market.
Next: 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.
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