Violation Tracker

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Violation Tracker Industry Summary Page

Industry: pharmaceuticals
Penalty Total since 2000: $116,245,163,450
Number of Records: 1,270
Note: The totals include only those entries matched to a parent company. The industry designation is the primary one for the parent's operations overall. The totals are adjusted to account for the fact that each parent's entries may include both agency records and settlement announcements for the same case; or else a penalty covering multiple locations may be listed in the individual records for each of the facilities. They are also adjusted to reflect cases in which federal and state or local agencies cooperated and issued separate announcements of the outcome. Duplicate or overlapping penalty amounts are marked with an asterisk in the individual records list below.

Top 10 Current Parent Companies	Total Penalty $	Number of Records
Johnson & Johnson	$24,497,162,770	88
Pfizer	$10,948,368,523	98
Merck	$10,710,400,031	89
Teva Pharmaceutical Industries	$10,242,576,796	96
GlaxoSmithKline	$9,572,803,406	50
Purdue Pharma	$9,278,372,787	11
AbbVie	$7,560,456,404	84
Takeda Pharmaceutical	$3,987,516,447	32
Endo International	$3,311,990,667	30
Eli Lilly	$2,831,299,676	26

Individual Penalty Records:

Click on the company or penalty amount for more information on each case. Click on the parent name to reach the summary page for that parent company.

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Company	Current Parent	Primary Offense Type	Year	Agency	Penalty Amount
Endo Health Solutions Inc.	Endo International	off-label or unapproved promotion of medical products	2014	FDA	$192,700,000
Johnson & Johnson	Johnson & Johnson	off-label or unapproved promotion of medical products	2013	FDA	$2,200,000,000
Wyeth Pharmaceuticals Inc.	Pfizer	off-label or unapproved promotion of medical products	2013	FDA	$490,900,000
Par Pharmaceutical Companies Inc.	Endo International	off-label or unapproved promotion of medical products	2013	FDA	$45,000,000
GlaxoSmithKline LLC	GlaxoSmithKline	off-label or unapproved promotion of medical products	2012	FDA	$3,000,000,000
Abbott Laboratories Inc.	AbbVie	off-label or unapproved promotion of medical products	2012	FDA	$1,500,000,000
Cypress Pharmaceutical Inc.	Currax Pharmaceuticals	off-label or unapproved promotion of medical products	2012	FDA	$2,800,000
Merck, Sharp & Dohme	Merck	off-label or unapproved promotion of medical products	2011	FDA	$950,000,000
Pfizer Inc.	Pfizer	off-label or unapproved promotion of medical products	2011	FDA	$14,500,000
Scios Inc.	Johnson & Johnson	off-label or unapproved promotion of medical products	2011	FDA	$85,000,000
Novo Nordisk Inc.	Novo Holdings A/S	off-label or unapproved promotion of medical products	2011	FDA	$25,000,000
UCB Inc.	UCB	off-label or unapproved promotion of medical products	2011	FDA	$34,000,000
Forest Pharmaceuticals Inc.	AbbVie	off-label or unapproved promotion of medical products	2011	FDA	$164,000,000
Elan Corporation PLC	Perrigo	off-label or unapproved promotion of medical products	2010	FDA	$203,000,000
Eisai Inc.	Eisai	off-label or unapproved promotion of medical products	2010	FDA	$11,000,000
Novartis Pharmaceuticals Corporation	Novartis	off-label or unapproved promotion of medical products	2010	FDA	$422,500,000
Allergan Inc.	AbbVie	off-label or unapproved promotion of medical products	2010	FDA	$600,000,000
Ortho-McNeil Pharmaceutical LLC	Johnson & Johnson	off-label or unapproved promotion of medical products	2010	FDA	$81,000,000
AstraZeneca LP	AstraZeneca	off-label or unapproved promotion of medical products	2010	FDA	$520,000,000
Amgen Inc.	Amgen	off-label or unapproved promotion of medical products	2012	FDA	$762,000,000
Warner Chilcott PLC	AbbVie	off-label or unapproved promotion of medical products	2015	FDA	$125,000,000
Shire Pharmaceuticals LLC	Takeda Pharmaceutical	off-label or unapproved promotion of medical products	2014	FDA	$56,500,000
Boehringer Ingelheim Pharmaceuticals Inc.	Boehringer Ingelheim	off-label or unapproved promotion of medical products	2012	FDA	$95,000,000
Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals Corporation	Novartis	off-label or unapproved promotion of medical products	2010	FDA	$72,500,000
Pfizer Inc.	Pfizer	off-label or unapproved promotion of medical products	2009	FDA	$2,300,000,000
Eli Lilly and Company	Eli Lilly	off-label or unapproved promotion of medical products	2009	FDA	$1,415,000,000
Cephalon Inc	Teva Pharmaceutical Industries	off-label or unapproved promotion of medical products	2008	FDA	$425,000,000
Otsuka American Pharmaceutical Inc.	Otsuka Pharmaceutical	off-label or unapproved promotion of medical products	2008	FDA	$4,000,000
Serono, S.A.	Merck KGaA (EMD)	off-label or unapproved promotion of medical products	2005	FDA	$704,000,000
Warner-Lambert	Pfizer	off-label or unapproved promotion of medical products	2004	FDA	$430,000,000
Eli Lilly and Company	Eli Lilly	off-label or unapproved promotion of medical products	2005	FDA	$36,000,000
InterMune Inc.	Roche	off-label or unapproved promotion of medical products	2006	FDA	$36,900,000
Bristol-Myers Squibb Company	Bristol-Myers Squibb	off-label or unapproved promotion of medical products	2007	DOJ_CIVIL	$515,000,000
Medicis Pharmaceutical Corporation	Bausch Health	off-label or unapproved promotion of medical products	2007	DOJ_CIVIL	$9,800,000
Mallinckrodt LLC	Mallinckrodt	Controlled Substances Act violation	2017	DEA	$35,000,000
Cephalon, Inc.	Teva Pharmaceutical Industries	off-label or unapproved promotion of medical products	2008	CT-AG	$6,150,000
Eli Lilly and Co.	Eli Lilly	off-label or unapproved promotion of medical products	2009	CT-AG	$25,100,000
Actavis Kadian, LLC	AbbVie	Medicare Coverage Gap Discount Program violation	2013	CMS	$116,703
Intermune, Inc.	Roche	Medicare Coverage Gap Discount Program violation	2013	CMS	$5,641
Intermune, Inc.	Roche	Medicare Coverage Gap Discount Program violation	2013	CMS	$16,215
Amneal Pharmaceutical, LLC	Amneal Pharmaceuticals	Medicare Coverage Gap Discount Program violation	2015	CMS	$5,909
Amneal Pharmaceutical, LLC	Amneal Pharmaceuticals	Medicare Coverage Gap Discount Program violation	2015	CMS	$9,440
Amneal Pharmaceutical, LLC	Amneal Pharmaceuticals	Medicare Coverage Gap Discount Program violation	2016	CMS	$10,788
Amneal Pharmaceuticals, LLC	Amneal Pharmaceuticals	Medicare Coverage Gap Discount Program violation	2016	CMS	$12,367
Amneal Pharmaceuticals, LLC	Amneal Pharmaceuticals	Medicare Coverage Gap Discount Program violation	2019	CMS	$12,968
Wockhardt USA	Wockhardt Limited	Medicare Coverage Gap Discount Program violation	2020	CMS	$111,824
Alnylam Pharmaceuticals, Inc.	Alnylam Pharmaceuticals	Medicare Coverage Gap Discount Program violation	2023	CMS	$31,959
Endo Pharmaceuticals	Endo International	off-label or unapproved promotion of medical products	2022	CA-SFCA	$10,000,000
Allergan	AbbVie	off-label or unapproved promotion of medical products	2022	CA-SFCA	$27,000,000
Teva Parmaceuticals	Teva Pharmaceutical Industries	off-label or unapproved promotion of medical products	2022	CA-SFCA	$27,000,000
Novo Nordisk Inc.	Novo Holdings A/S	off-label or unapproved promotion of medical products	2017	CA-INS	$1,100,000
Eli Lilly	Eli Lilly	off-label or unapproved promotion of medical products	2010	AR-AG	$18,500,000