{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T21:43:11Z","timestamp":1793828591428,"version":"4.6.1"},"reference-count":82,"publisher":"Cambridge University Press (CUP)","issue":"S4","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"unspecified","delay-in-days":731,"URL":"https:\/\/www.cambridge.org\/core\/terms"},{"start":{"date-parts":[[2019,1,1]],"date-time":"2019-01-01T00:00:00Z","timestamp":1546300800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J. Law. Med. Ethics"],"published-print":{"date-parts":[[2019]]},"abstract":"<jats:p>Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone \u2014 including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses \u2014 helped to maintain high prices by extending brand exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017.<\/jats:p>","DOI":"10.1177\/1073110519898042","type":"journal-article","created":{"date-parts":[[2020,1,20]],"date-time":"2020-01-20T05:12:10Z","timestamp":1579497130000},"page":"43-53","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":7,"title":["Generic Drug Policy and Suboxone to Treat Opioid Use Disorder"],"prefix":"10.1017","volume":"47","author":[{"given":"Rebecca L.","family":"Haffajee","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard G.","family":"Frank","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2021,1,1]]},"reference":[{"key":"S1073110500022592_bib26","unstructured":"26. Fowler, A.C. , \u201cPharmaceutical Line Extensions in the United States: A Primer on Definitions and Incentives,\u201d NBER White Paper, Oct. 6, 2017, available at <http:\/\/www.nber.org\/aging\/valmed\/WhitePaper-Fowler10.2017.pdf> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib70","unstructured":"70. Id."},{"key":"S1073110500022592_bib25","unstructured":"25. Feldman and Frondorf, supra note 23."},{"key":"S1073110500022592_bib34","unstructured":"34. Brill, A. , \u201cLost Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry,\u201d July 2014, Matrix Global Advisors, available at <https:\/\/static1.1.sqspcdn.com\/static\/f\/460582\/25228342\/1406034596510\/REMS_Study_July.pdf> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib19","unstructured":"19. Drug Price Competition and Patent Term Restoration Act, P. L. 98-417 (1984)."},{"key":"S1073110500022592_bib45","unstructured":"45. Id."},{"key":"S1073110500022592_bib41","unstructured":"41. 21 C.F.R. \u00a7 10, 1979."},{"key":"S1073110500022592_bib2","doi-asserted-by":"publisher","DOI":"10.1016\/j.amepre.2017.12.022"},{"key":"S1073110500022592_bib22","unstructured":"22. Id."},{"key":"S1073110500022592_bib7","unstructured":"7. Schuckit, M.A. , \u201cTreatment of Opioid-Use Disorders,\u201d New England Journal of Medicine 374, no. 4 (2016): 357-368, at 361-363; PEW Charitable Trusts, Medication-Assisted Treatment Improves Outcomes for Patients with Opioid Use Disorder (2016), available at <https:\/\/www.pewtrusts.org\/-\/media\/assets\/2016\/11\/medicationassistedtreatment_v3.pdf> (last visited December 4, 2019); Substance Abuse and Mental Health Services Administration, \u201cBuprenorphine,\u201d 2019, available at <https:\/\/www.samhsa.gov\/medication-assisted-treatment\/treatment\/buprenorphine> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib44","first-page":"305","article-title":"\u201cCitizen Petitions: Long, Late-Filed, and at-Last Denied,\u201d","volume":"66","author":"Carrier","year":"2016","journal-title":"American University Law Review"},{"key":"S1073110500022592_bib71","unstructured":"71. Food and Drug Administration, \u201cProposed Guidance: Citizen Petitions and Petitions for Stay of Action Subject to Section 505 (q) of the Federal Food, Drug, and Cosmetic Act, Guidance for Industry,\u201d (2018): 1-17."},{"key":"S1073110500022592_bib61","unstructured":"61. Feldman and Frondorf, supra note 23."},{"key":"S1073110500022592_bib64","first-page":"663","article-title":"\u201cShould Pharmaceutical Product Hopping Be Subject to Antitrust Scrutiny,\u201d","volume":"97","author":"Iyengar","year":"2015","journal-title":"Journal of the Patent and Trademark Office Society"},{"key":"S1073110500022592_bib48","unstructured":"48. Reckitt Benckiser Pharmaceuticals, Inc., Citizen Petition, No. FDA-2012-P-1028, Sept. 25, 2012, available at <https:\/\/www.naabt.org\/documents\/Reckitt_Benckiser_Pharmaceuticals_Inc_2012_FDA_Citizen_Petition.pdf> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib56","unstructured":"56. U.S. Department of Justice, \u201cPress Release: Indivior Indicted for Fraudulently Marketing Prescription Opioid,\u201d Apr. 9, 2019, available at <https:\/\/www.justice.gov\/opa\/pr\/indivior-incindicted-fraudulently-marketing-prescription-opioid> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib67","unstructured":"67. Dabrowska, supra note 30, at 5-8."},{"key":"S1073110500022592_bib68","unstructured":"68. \u201cThe Lower Health Care Costs Act,\u201d S. 1985 (sponsored by Sen. L. Alexander), introduced Jun. 19, 2019."},{"key":"S1073110500022592_bib32","unstructured":"32. Id."},{"key":"S1073110500022592_bib79","unstructured":"79. 21 U.S.C. \u00a7255(a)(1)(E)."},{"key":"S1073110500022592_bib23","first-page":"499","article-title":"\u201cDrug Wars: A New Generation of Generic Pharmaceutical Delay,\u201d","volume":"53","author":"Feldman","year":"2016","journal-title":"Harvard Journal on Legislation"},{"key":"S1073110500022592_bib24","unstructured":"24. Id.; Complaint, supra note 5, at 10-11."},{"key":"S1073110500022592_bib15","unstructured":"15. See Indivior, supra note 13."},{"key":"S1073110500022592_bib54","unstructured":"54. Indivior, \u201cIndivior Enters into Settlement with Par Pharmaceutical in Patent Infringement Case,\u201d May 14, 2018, available at <http:\/\/www.indivior.com\/investor-news\/indivior-enters-settlement-par-pharmaceutical-patent-infringement-case\/> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib27","doi-asserted-by":"publisher","DOI":"10.1080\/13571516.2011.584423"},{"key":"S1073110500022592_bib37","unstructured":"37. Dabrowska, supra note 30, at 11."},{"key":"S1073110500022592_bib60","unstructured":"60. Senate Permanent Subcommittee on Investigations, Combatting the Opioid Crisis: The Price Increase of an Opioid Overdose Reversal Drug and the Cost to the U.S. Health Care System Combatting the Opioid Crisis, Committee on Homeland Security (2018)."},{"key":"S1073110500022592_bib18","unstructured":"18. Alexander, P. , \u201cAs Manufacturer of Leading Addiction Drug Comes under Legal Fire, A New Competitor Emerges,\u201d Huff Post, Oct. 27, 2016, available at <https:\/\/www.huffpost.com\/entry\/as-manufacturer-of-leading-addiction-drug-comes-under_b_5811abb4e4b08301d33e058f>; Indivior, \u201c2015 Annual Report,\u201d 2016, available at <http:\/\/www.indivior.com\/2015-annual-report\/indivior-07-us-competition\/> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib49","unstructured":"49. Food and Drug Administration, \u201cFDALawBlog's Citizen Petition Tracker,\u201d 2012, available at <www.fdalawblog.net\/wp-content\/uploads\/CPTracker.xls> (last visited December 4, 2019); Food and Drug Administration, Response Letter to Reckitt Benckiser Pharmaceuticals, Inc. 2012 FDA Citizen Petition (FDA-2012-P-1028), Feb. 22, 2013, available at <https:\/\/www.regulations.gov\/document?D=FDA-2012-P-1028-0011> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib57","unstructured":"57. Faulkner, J. , \u201cReckitt to Pay $1.4B to End US Opioid Probe,\u201d Law360, July 11, 2019, available at <https:\/\/www.law360.com\/articles\/1177241> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib72","unstructured":"72. Id."},{"key":"S1073110500022592_bib55","unstructured":"55. Memorandum Opinion, State of Wisconsin, et al. v. Indivior Inc. f\/k\/a Reckitt Benckiser Pharmaceuticals Inc., et al, 2:15-cv-01621-MSG (E.D. Pa decided Oct. 25, 2017)."},{"key":"S1073110500022592_bib75","first-page":"115","article-title":"\u201cCitizen Petitions: A Process Hijacked by Big Pharma?\u201d","volume":"5","author":"Evans","year":"2017","journal-title":"Emory Corporate Governance and Accountability Review"},{"key":"S1073110500022592_bib29","unstructured":"29. U.S. Food and Drug Administration, \u201cRisk Evaluation and Mitigation Strategies (REMS),\u201d Feb. 2, 2018, available at <https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/risk-evaluation-and-mitigation-strategies-rems> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib77","volume-title":"\u201cSenate Testimony: Improving Access to Generic Drugs,\u201d","author":"Buehler","year":"2006"},{"key":"S1073110500022592_bib78","unstructured":"78. Evans, supra note 75."},{"key":"S1073110500022592_bib30","first-page":"5","volume-title":"\u201cFDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development,\u201d","author":"Dabrowska","year":"2018"},{"key":"S1073110500022592_bib9","unstructured":"9. 21 U.S.C. \u00a7 801. Controlled Substances Act (1970)."},{"key":"S1073110500022592_bib46","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1700202"},{"key":"S1073110500022592_bib80","first-page":"81","article-title":"\u201cFive Actions to Stop Citizen Petition Abuse,\u201d","volume":"118","author":"Carrier","year":"2018","journal-title":"Columbia Law Review Online"},{"key":"S1073110500022592_bib76","unstructured":"76. Id.; Feldman and Wang, supra note 46, at 1499-1500."},{"key":"S1073110500022592_bib16","doi-asserted-by":"crossref","first-page":"1820","DOI":"10.1001\/jama.2016.10899","article-title":"\u201cBuprenorphine Implants (Probuphine) for Opioid Dependence,\u201d","volume":"316","year":"2016","journal-title":"JAMA"},{"key":"S1073110500022592_bib50","unstructured":"50. Id."},{"key":"S1073110500022592_bib59","unstructured":"59. Id."},{"key":"S1073110500022592_bib1","article-title":"\u201cDrug Overdose Deaths in the United States, 1999\u20132017,\u201d","author":"Hedegaard","year":"2018","journal-title":"National Center for Health Statistics Data Brief"},{"key":"S1073110500022592_bib73","unstructured":"73. 21 U.S.C. \u00a7255(a)(1)(E)."},{"key":"S1073110500022592_bib17","unstructured":"17. Jensen, K. , \u201cDr. Reddy's Relaunches Suboxone Generic after Court Victories,\u201d BioPharma Dive, Feb. 22, 2019, available at <https:\/\/www.biopharmadive.com\/news\/dr-reddysrelaunches-suboxone-generic-after-court-victories\/548907\/> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib42","volume-title":"\u201cImproving Access to Generic Drugs,\u201d","author":"Buehler","year":"2006"},{"key":"S1073110500022592_bib28","unstructured":"28. Complaint, supra note 5, at 20-24."},{"key":"S1073110500022592_bib40","unstructured":"40. Id."},{"key":"S1073110500022592_bib38","unstructured":"38. Feldman and Frondorf, supra note 23."},{"key":"#cr-split#-S1073110500022592_bib3.1","unstructured":"3. 21st Century Cures Act, P.L. 114-255 (2016)"},{"key":"#cr-split#-S1073110500022592_bib3.2","unstructured":"the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, P.L. 115-271 (2018)."},{"key":"S1073110500022592_bib51","unstructured":"51. Monosol Rx, Citizen Petition, No. FDA-2013-P-0995-0001, Aug. 2013, available at <https:\/\/www.regulations.gov\/document?D=FDA-2013-P-0995-0001> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib33","unstructured":"33. Id., at 10-12."},{"key":"S1073110500022592_bib13","unstructured":"13. Indivior, \u201cAbout,\u201d 2019, available at <http:\/\/www.indivior.com\/about\/our-history\/> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib69","unstructured":"69. \u201cThe Creating and Restoring Equal Access to Equivalent Samples Act of 2018 (CREATES Act),\u201d S. 340 (sponsored by Sen. P. Leahy), introduced Feb. 5, 2019."},{"key":"S1073110500022592_bib52","unstructured":"52. Food and Drug Administration, \u201cFDALawBlog's Citizen Petition Tracker,\u201d 2013, available at <www.fdalawblog.net\/wp-content\/uploads\/CPTracker.xls> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib53","unstructured":"53. Complaint, supra note 5, at 2-7."},{"key":"S1073110500022592_bib74","unstructured":"74. Feldman and Wang, supra note 46, at 1500."},{"key":"S1073110500022592_bib63","unstructured":"63. Feldman and Frondorf, supra note 23."},{"key":"#cr-split#-S1073110500022592_bib5.1","unstructured":"5. Complaint at 10-11, State of Wisconsin, et al. v. Indivior Inc. f\/k\/a Reckitt Benckiser Pharmaceuticals Inc., et al, 2:15-cv-01621-MSG (E.D. Pa filed Sept. 28, 2016)"},{"key":"#cr-split#-S1073110500022592_bib5.2","unstructured":"Moraff, C. , \"Suboxone Creator's Shocking Scheme to Profit Off of Heroin Addicts,\" Daily Beast, Apr. 13, 2017, available at <https:\/\/www.thedailybeast.com\/suboxone-creators-shocking-scheme-to-profit-off-of-heroin-addicts> (last visited December 4, 2019)."},{"key":"S1073110500022592_bib8","unstructured":"8. Id."},{"key":"S1073110500022592_bib10","unstructured":"10. See Substance Abuse and Mental Health Services Administration, supra note 7."},{"key":"S1073110500022592_bib31","unstructured":"31. Id., at 6-7."},{"key":"S1073110500022592_bib43","unstructured":"43. Food and Drug Administration Amendments Act, P.L. 110-85 (2007)."},{"key":"S1073110500022592_bib66","doi-asserted-by":"publisher","DOI":"10.1080\/13571516.2015.1045745"},{"key":"S1073110500022592_bib36","unstructured":"36. 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