{"abstract":"The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANDEMBRY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/09/09/2026-18300.html","cfr_references":[],"citation":"91 FR 57356","comment_url":"http://www.regulations.gov/commenton/FDA-2025-E-3595-0005","comments_close_on":"2027-03-08","correction_of":null,"corrections":[],"dates":"Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic or written comments and ask for a redetermination by November 9, 2026. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 8, 2027. See \"Petitions\" in the SUPPLEMENTARY INFORMATION section for more information.","disposition_notes":null,"docket_ids":["Docket Nos. FDA-2025-E-3595 and FDA-2025-E-3596"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-09-09","updated_at":"2026-09-09T10:56:48.626-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-E-3595-0005","allow_late_comments":false,"id":"FDA-2025-E-3595-0005","comment_end_date":"2026-11-10","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA-2025-E-3595","title":"Patent Term Extension Application for ANDEMBRY (garadacimab-gxii) Patent No. 9,518,127"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-09-09","updated_at":"2026-09-09T10:56:52.208-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-E-3596-0005","allow_late_comments":false,"id":"FDA-2025-E-3596-0005","comment_end_date":"2026-11-10","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA-2025-E-3596","title":"Patent Term Extension Application for ANDEMBRY (garadacimab-gxii) Patent No. 11,174,321"}],"document_number":"2026-18300","effective_on":null,"end_page":57358,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/09/09/2026-18300.xml","html_url":"https://www.federalregister.gov/documents/2026/09/09/2026-18300/determination-of-regulatory-review-period-for-purposes-of-patent-extension-andembry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-18300?publication_date=2026-09-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-09-09/2026-18300/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":159,"last_updated":"2026-10-23 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18300.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18300.pdf?1788871513","publication_date":"2026-09-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/09/09/2026-18300.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2025-E-3595","supporting_documents_count":0,"docket_id":"FDA-2025-E-3595","document_id":"FDA-2025-E-3595-0005","regulation_id_number":null,"title":"Patent Term Extension Application for ANDEMBRY (garadacimab-gxii) Patent No. 9,518,127","checked_regulationsdotgov_at":"2026-09-10T17:55:04Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2025-E-3595-0005","significant":null,"signing_date":null,"start_page":57356,"subtype":null,"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY","toc_doc":"Andembry","toc_subject":"Patent Extension Regulatory Review Period","topics":[],"type":"Notice","volume":91}