{"abstract":"The Food and Drug Administration (FDA) has determined the regulatory review period for HORIZANT 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 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/2014/07/11/2014-16237.html","cfr_references":[],"citation":"79 FR 40108","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2012-E-0434"],"dockets":[],"document_number":"2014-16237","effective_on":null,"end_page":40109,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/07/11/2014-16237.xml","html_url":"https://www.federalregister.gov/documents/2014/07/11/2014-16237/determination-of-regulatory-review-period-for-purposes-of-patent-extension-horizant","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-16237?publication_date=2014-07-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-07-11/2014-16237/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":123,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-07-11/pdf/2014-16237.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-16237.pdf?1404996618","publication_date":"2014-07-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/07/11/2014-16237.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-E-0434","supporting_documents_count":0,"docket_id":"FDA-2012-E-0434","regulation_id_number":null,"title":"Patent Term Extension Application, HORIZANT™ (gabapentin enacarbil); U.S. Patent No. 6,818,787","checked_regulationsdotgov_at":"2014-09-10T05:00:59Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":40108,"subtype":null,"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; HORIZANT","toc_doc":"HORIZANT","toc_subject":"Determination of Regulatory Review Period for Purposes of Patent Extensions:","topics":[],"type":"Notice","volume":79}