{"abstract":"The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VUMERITY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug 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/2022/07/25/2022-15823.html","cfr_references":[],"citation":"87 FR 44126","comment_url":null,"comments_close_on":"2022-09-23","correction_of":null,"corrections":[],"dates":"Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by September 23, 2022. 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 January 23, 2023. See \"Petitions\" in the SUPPLEMENTARY INFORMATION section for more information.","disposition_notes":null,"docket_ids":["Docket Nos. FDA-2020-E-2040","FDA-2020-E-2041","and FDA-2020-E-2051"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-07-25","updated_at":"2023-02-27T21:59:29.311-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-E-2040-0004","allow_late_comments":null,"id":"FDA-2020-E-2040-0004","comment_end_date":"2022-09-24","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-E-2040","title":"Patent Term Extension Application for VUMERITY patent # 8,669,281 "},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-07-25","updated_at":"2023-02-27T21:59:29.744-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-E-2041-0004","allow_late_comments":null,"id":"FDA-2020-E-2041-0004","comment_end_date":"2022-09-24","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-E-2041","title":"Patent Term Extension Application for VUMERITY patent # 9,090,558"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-07-25","updated_at":"2023-02-27T21:59:28.823-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-E-2051-0004","allow_late_comments":null,"id":"FDA-2020-E-2051-0004","comment_end_date":"2022-09-24","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-E-2051","title":"Patent Term Extension Application for VUMERITY (diroximel fumarate), Patent No. 10,080,733"}],"document_number":"2022-15823","effective_on":null,"end_page":44128,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/07/25/2022-15823.xml","html_url":"https://www.federalregister.gov/documents/2022/07/25/2022-15823/determination-of-regulatory-review-period-for-purposes-of-patent-extension-vumerity","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-15823?publication_date=2022-07-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-07-25/2022-15823/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":617,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-07-25/pdf/2022-15823.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-15823.pdf?1658493925","publication_date":"2022-07-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/07/25/2022-15823.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-2020-E-2041","supporting_documents_count":0,"docket_id":"FDA-2020-E-2041","document_id":"FDA-2020-E-2041-0004","regulation_id_number":null,"title":"Patent Term Extension Application for VUMERITY patent # 9,090,558","checked_regulationsdotgov_at":"2024-04-09T21:00:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44126,"subtype":null,"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; VUMERITY","toc_doc":"Vumerity","toc_subject":"Patent Extension Regulatory Review Period:\n","topics":[],"type":"Notice","volume":87}