Cevimeline Hydrochloride

Treats symptoms of dry mouth. Sold as Evoxac. Every FDA application for this active ingredient: 2 branded and 9 generic.

As of Nov 14, 2026, FDA lists 11 applications for Cevimeline Hydrochloride (sold as Evoxac), first approved Jan 11, 2000, with 0 new uses approved and 0 published complete response letters.

First approved: Jan 11, 2000
Applications: 11
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $21.0M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Cevimeline HCl	Part D	$20.1M	+4%	32,202
Evoxac	Part D	$867K	-14%	158

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

CEVIMELINE HCL 30 MG CAPSULE: $0.724 per unitGeneric · +3% in a year
EVOXAC 30 MG CAPSULE: $8.59 per unitBrand · +10% in a year

Applications

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


Jan 11, 2000	EvoxacNDA 20989 · New molecular entity	Cosette	7	Marketed
Aug 25, 2011	Cevimeline HydrochlorideANDA 91260	Apotex Inc	0	Discontinued
Jul 8, 2013	Cevimeline HydrochlorideANDA 91591	Hikma	0	Marketed
Jun 4, 2014	Cevimeline HydrochlorideANDA 203775	Rising	1	Marketed
Dec 30, 2016	Cevimeline HydrochlorideANDA 204746	Novel Labs Inc	0	Marketed
Apr 6, 2023	Cevimeline HydrochlorideANDA 216682	Rubicon Research	0	Marketed
Apr 18, 2023	Cevimeline HydrochlorideANDA 215056	Aurobindo Pharma	0	Marketed
Nov 8, 2023	Cevimeline HydrochlorideANDA 218290	Bionpharma	0	Marketed
Sep 20, 2024	Cevimeline HydrochlorideANDA 206808	Macleods Pharms	0	Marketed
Mar 11, 2026	Cevimeline HydrochlorideANDA 220267	Zydus Lifesciences	0	Marketed
Oct 15, 2026	EvoxacNDA 221183 · New dosage form	Cosette	0	Marketed

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; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA