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VYLOY Patent Extension Comment Period

FDA has opened a public comment period on a patent term extension application for VYLOY (citizens乏 details unspecified). Comments on FDA-2025-E-0866-0006 must be submitted by June 2, 2025. This consultation allows interested parties to provide input on the patent extension determination.

ENCELTO Regulatory Review Period Determination for Patent Extension

The FDA has determined the regulatory review period for ENCELTO, a human biological product, and published this notice as required by law for patent extension purposes. Any person may submit comments on the accuracy of the published dates by June 2, 2026, or petition FDA regarding due diligence by September 30, 2026.

Background Material Supporting Proposed Regulatory Action

The FDA published background material supporting docket FDA-2026-P-3665. This document provides supplementary information related to a proposed regulatory action in the pharmaceutical or medical product space. The docket is open for public review and potential comment submission.

VYLOY Regulatory Review Period Patent Extension Comment Form

FDA opened a public comment period on the regulatory review period patent extension for VYLOY (vonoprazan), a potassium-competitive acid blocker approved for gastric acid-related conditions. Comments are being accepted through regulations.gov docket FDA-2025-E-0845. Stakeholders may submit comments on behalf of themselves, organizations, or anonymously.

VYLOY Patent Extension Application Comment Period

FDA opened a 60-day public comment period on a patent term extension application for VYLOY, a drug product. Commenters may submit feedback through regulations.gov regarding this application.

FDA Acknowledgement of Submission from Hyman Phelps McNamara

FDA CDER issued an acknowledgement letter to Hyman, Phelps & McNamara, P.C. regarding a submission under docket FDA-2026-P-3664-0002. The acknowledgement confirms receipt of the submission but no substantive regulatory action is detailed in the available metadata.

INJECTAFER Regulatory Review Period for Patent Extension

FDA has determined the regulatory review period for INJECTAFER (ferric carboxymaltose injection) for purposes of patent extension under 35 U.S.C. 156. The Agency published this notice as required by law following a patent extension application submitted to the USPTO. Any person with knowledge of incorrect dates may submit comments by June 2, 2026, or petition FDA regarding due diligence by September 30, 2026.

VYLOY Patent Extension Notice Comment

FDA is accepting public comments on a patent term extension notice for VYLOY (cisplatin), a chemotherapy drug. Comments are being submitted through Regulations.gov docket FDA-2025-E-0863. The notice relates to potential patent term extension eligibility under the Drug Price Competition and Patent Term Restoration Act.

EMRELIS Patent Extension Comment Form

FDA has opened a public comment period for EMRELIS patent extension matter via regulations.gov docket FDA-2025-E-3073. The 60-day comment window allows interested parties to submit feedback on the patent term extension application. Commenters may submit as individuals, organizations, or anonymously with attachments up to 10MB.

VYLOY Patent Extension Comment Period Notice

The FDA has opened a 60-day public comment period for a patent extension application related to the drug VYLOY (zolbetuximab). Pharmaceutical companies and other interested parties may submit comments on the patent term restoration matter. The comment period provides an opportunity for stakeholders to voice concerns or support regarding the extension.