Pilocarpine Hydrochloride

Treats symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for…. Sold as Pilopine Hs, Salagen, Isopto Carpine, Vuity, Qlosi. Every FDA application for this active ingredient: 5 branded and 10 generic.

As of Nov 15, 2026, FDA lists 15 applications for Pilocarpine Hydrochloride (sold as Pilopine Hs, Salagen, Isopto Carpine and others), first approved Oct 1, 1984, with 2 new uses approved and 0 published complete response letters.

First approved: Oct 1, 1984
Applications: 15
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $23.8M

Medicare Spending

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


Pilocarpine HCl	Part D	$23.6M	+11%	105,825
Vuity	Part D	$144K	-36%	571
Salagen	Part D	$28K	-10%	23

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

PILOCARPINE 1% EYE DROPS: $3.38 per MLGeneric · -4% in a year
PILOCARPINE 2% EYE DROPS: $2.74 per MLGeneric · -25% in a year
PILOCARPINE 4% EYE DROPS: $3.30 per MLGeneric · -8% in a year
PILOCARPINE HCL 1.25% EYE DROP: $21.77 per MLGeneric · new this year
PILOCARPINE HCL 5 MG TABLET: $0.310 per unitGeneric · -17% in a year
PILOCARPINE HCL 7.5 MG TABLET: $0.341 per unitGeneric · -22% in a year
VUITY 1.25% EYE DROP: $31.39 per MLBrand · +6% in a year

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of xerostomia induced by radiation therapy for head and neck cancer.MGI Pharma, Inc. · designated Sep 24, 1990 · approved Mar 22, 1994

Clinical Trials

8 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Contamination of Young Children Hair During Acute Cannabis IntoxicationCannabis Intoxication in Children · University Hospital, Toulouse	Not applicable	Recruiting	Apr 13, 2026
Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR FunctionCystic Fibrosis · Emory University	Not applicable	Not yet recruiting	Feb 17, 2026
Quality of Life in Presbyopic Patients Who Are Treated With QlosiPresbyopia, Glasses · Southern College of Optometry	Phase 4	Recruiting	Aug 8, 2025
KERMIT: Sweat Patch for Early Kidney Disease DetectionChronic Kidney Disease (CKD) · University of Ioannina	Not applicable	Not yet recruiting	Jul 2, 2025
Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in ChildrenPupillary Constriction, Accomodation · Mansoura University	Not applicable	Not yet recruiting	Jun 10, 2025
Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat TrialGlaucoma, Open-Angle, Pseudoexfoliation Glaucoma · Vastra Gotaland Region	Not applicable	Enrolling by invitation	Dec 16, 2021
Pilocarpine Use After Kahook GoniotomyGlaucoma · Montefiore Medical Center	Phase 3	Recruiting	May 1, 2019
Optimal Treatment Protocol for Selective Laser TrabeculoplastyGlaucoma, Open-Angle, Pseudoexfoliation Glaucoma · Vastra Gotaland Region	Not applicable	Active, not recruiting	Jan 9, 2019

Applications

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


Oct 1, 1984	Pilopine HsNDA 18796 · New dosage form	Alcon	11	Discontinued
Mar 22, 1994	SalagenNDA 20237 · New dosage form	Advanz Pharma	14	Marketed
Nov 16, 2004	Pilocarpine HydrochlorideANDA 76746	Padagis US	2	Discontinued
Dec 22, 2004	Pilocarpine HydrochlorideANDA 76963	Innogenix	4	Marketed
Oct 14, 2005	Pilocarpine HydrochlorideANDA 77220	Lannett Co Inc	1	Marketed
Mar 31, 2006	Pilocarpine HydrochlorideANDA 77248	Impax Labs	0	Marketed
Jun 22, 2010	Isopto CarpineNDA 200890 · New dosage form	Sandoz	4	Marketed
Sep 27, 2017	Pilocarpine HydrochlorideANDA 204398	Rising	1	Marketed
Aug 13, 2019	Pilocarpine HydrochlorideANDA 212377	Quagen	0	Marketed
Nov 25, 2019	Pilocarpine HydrochlorideANDA 210384	Somerset Theraps LLC	0	Marketed
Sep 21, 2020	Pilocarpine HydrochlorideANDA 214193	Amneal	0	Marketed
Oct 28, 2021	VuityNDA 214028 · New formulation or manufacturer	Abbvie	3	Discontinued
Oct 17, 2023	QlosiNDA 217836 · New dosage form	Orasis Pharms	0	Marketed
Apr 28, 2025	Pilocarpine HydrochlorideANDA 217733	Amneal	0	Marketed
Oct 2, 2025	Pilocarpine HydrochlorideANDA 217052	Fdc Ltd	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