{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T05:53:20Z","timestamp":1790920400077,"version":"4.1.0"},"reference-count":10,"publisher":"Cambridge University Press (CUP)","license":[{"start":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T00:00:00Z","timestamp":1790899200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/www.cambridge.org\/core\/terms"}],"funder":[{"DOI":"10.13039\/100014848","name":"Arnold Ventures","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014848","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000905","name":"Commonwealth Fund","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000905","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Law. Med. Ethics"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Patents listed in the US Food and Drug Administration\u2019s (FDA) Orange Book can delay generic competition, yet little is known about how often patents are removed before expiration or why these delistings occur. We reviewed Orange Book records from 1998 through 2024 to identify patents removed before their expiration dates, classified patents according to the subject matter of their claims and assessed potential reasons for delisting using patent litigation and prosecution databases, FDA records, and Federal Trade Commission (FTC) actions. Among 9,980 patents listed during the study period, 535 (5%) were delisted before expiration. Only 71 (13%) claimed active ingredients; most delisted patents instead covered methods of use (177, 38%), formulations (167, 36%), or delivery devices (75, 16%). Potential reasons for delisting included potential invalidation in litigation (226, 42%), product discontinuation (207, 39%), and patent reexamination or reissue (60,11%). Orange Book patent delistings predominantly involved secondary patents rather than active-ingredient patents. Greater clarity and oversight regarding Orange Book listing requirements could reduce questionable listings and unnecessary barriers to generic competition.<\/jats:p>","DOI":"10.1017\/jme.2026.10292","type":"journal-article","created":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T05:05:35Z","timestamp":1790917535000},"page":"1-4","source":"Crossref","is-referenced-by-count":0,"title":["Delisted Patents on Pharmaceuticals, 1998\u20132024"],"prefix":"10.1017","author":[{"given":"Lily","family":"Kirby-Rivera","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02aqsxs83","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Oklahoma"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Feldman","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/046rm7j60","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Medicine, University of California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myongjin","family":"Kim","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02aqsxs83","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Oklahoma"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgia","family":"Kosmopoulou","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02aqsxs83","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Oklahoma"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron Seth","family":"Kesselheim","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0391-8186","authenticated-orcid":false,"given":"S. Sean","family":"Tu","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital"},{"id":[{"id":"https:\/\/ror.org\/051fvmk98","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Alabama School of Law"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2026,10,2]]},"reference":[{"key":"S1073110526102927_r9","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0049470"},{"key":"S1073110526102927_r3","unstructured":"3. Federal Trade Commission, \u201cFTC Renews Challenge of More than 200 Improper Patent Listings,\u201d press release, May 21, 2025, https:\/\/www.ftc.gov\/news-events\/news\/press-releases\/2025\/05\/ftc-renews-challenge-more-200-improper-patent-listings (last visited September 9, 2026)."},{"key":"S1073110526102927_r4","unstructured":"4. Teva Branded Pharm. Prods. R&D Inc. v. Amneal Pharms. of N.Y., LLC, 124 F.4th 898. (Fed. Cir. 2024)."},{"key":"S1073110526102927_r10","first-page":"49","article-title":"Autum is Coming: A Novel Liability Theory that May Kill Pharmaceutical Evergreening","volume":"40","author":"Hacohen","year":"2022","journal-title":"Cardozo Arts and Entertainment Law Journal"},{"key":"S1073110526102927_r2","unstructured":"2. Cesar Castillo, Inc. v. Sanofi-Aventis U.S., LLC (In re Lantus Direct Purchaser Antitrust Litigation), 950 F.3d. 1 (1st Cir. 2020)."},{"key":"S1073110526102927_r7","unstructured":"7. \u201c\u2018Deemed to be a License Provision of the BPCI Act,\u2019\u201d US Food and Drug Administration, February 29, 2024, https:\/\/www.fda.gov\/drugs\/guidance-compliance-regulatory-information\/deemed-be-license-provision-bpci-act (last visited September 9, 2026)."},{"key":"S1073110526102927_r8","unstructured":"8. Leon et al., \u201cDelisting of Pharmaceutical Patents Challenged by the Federal Trade Commission.\u201d"},{"key":"S1073110526102927_r5","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2025.5909"},{"key":"S1073110526102927_r6","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2026.0980"},{"key":"S1073110526102927_r1","unstructured":"1. Apotex, Inc. v. Thompson, 347 F.3d 1335, 1347 (Fed. Cir. 2003)."}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1073110526102927","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T05:05:37Z","timestamp":1790917537000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1073110526102927\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,2]]},"references-count":10,"alternative-id":["S1073110526102927"],"URL":"https:\/\/doi.org\/10.1017\/jme.2026.10292","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"value":"1073-1105","type":"print"},{"value":"1748-720X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,2]]}}}