{"description":"Documents matching 'abaloparatide'","count":1,"total_pages":1,"results":[{"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; TYMLOS","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TYMLOS 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.","document_number":"2018-22956","html_url":"https://www.federalregister.gov/documents/2018/10/22/2018-22956/determination-of-regulatory-review-period-for-purposes-of-patent-extension-tymlos","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-10-22/pdf/2018-22956.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-22956.pdf?1539953134","publication_date":"2018-10-22","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"}],"excerpts":"patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). \n \n FDA has approved for marketing the human drug product TYMLOS (<span class=\"match\">abaloparatide</span>). TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Subsequent to this approval, the USPTO received patent term restoration applications for TYMLOS (U.S. Patent Nos. 7,803,770; 8,148,333; and 8,748,382) from Radius"}]}