Ezetimibe

Reduces elevated sitosterol and campesterol levels. Sold as Zetia. Every FDA application for this active ingredient: 1 branded and 16 generic.

As of Nov 13, 2026, FDA lists 17 applications for Ezetimibe (sold as Zetia), first approved Oct 25, 2002, with 5 new uses approved and 0 published complete response letters.

First approved: Oct 25, 2002
Applications: 17
New uses approved: 5
Complete response letters: 0
Medicare spending, 2024: $215M

Medicare Spending

CMS Part D and Part B, 2024, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2024	Change	Beneficiaries
Ezetimibe	Part D	$209M	-28%	2,411,057
Zetia	Part D	$5.8M	-13%	1,813

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Oct 25, 2002	ZetiaNDA 21445 · New molecular entity	Organon	28	Marketed
Jun 26, 2015	EzetimibeANDA 78560	Glenmark Pharms Ltd	2	Marketed
Jun 12, 2017	EzetimibeANDA 78724	Teva Pharms USA	0	Discontinued
Jun 12, 2017	EzetimibeANDA 200831	Watson Labs Inc	2	Discontinued
Jun 12, 2017	EzetimibeANDA 203931	Sandoz	2	Marketed
Jun 12, 2017	EzetimibeANDA 204331	Zydus Pharms	2	Marketed
Jun 12, 2017	EzetimibeANDA 207311	Ohm Labs Inc	2	Marketed
Jun 12, 2017	EzetimibeANDA 208332	Apotex	2	Discontinued
Jun 12, 2017	EzetimibeANDA 208803	Amneal Pharms Co	2	Marketed
Aug 25, 2017	EzetimibeANDA 209838	Aurobindo Pharma	2	Marketed
Dec 21, 2017	EzetimibeANDA 209234	Alkem Labs Ltd	4	Marketed
Oct 26, 2018	EzetimibeANDA 211550	Accord Hlthcare	2	Marketed
Apr 26, 2019	EzetimibeANDA 201790	Rising	0	Discontinued
Oct 23, 2020	EzetimibeANDA 210673	Sciegen Pharms	2	Marketed
Jul 26, 2022	EzetimibeANDA 210859	Hetero Labs Ltd Iii	1	Marketed
Sep 13, 2022	EzetimibeANDA 215693	Orient Pharma	2	Marketed
Apr 29, 2024	EzetimibeANDA 211159	Macleods Pharms	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA