Regulatory PathRegulatory requirements compared

Active substance

Pilocarpine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
APICARPINE 2% EYE DROPS2 %Eye drops · Ophthalmic use1 Dropper ContainerSAR 4.05Generic · PrescriptionAmman Pharmaceutical Industries (API)Valid
APICARPINE 4% EYE DROPS4 %Eye drops · Ophthalmic use1 Dropper ContainerSAR 7.75Generic · PrescriptionAmman Pharmaceutical Industries (API)Valid
ISOPTO CARPIN 2% EYE DROPS2 %Eye drops, solution · Ocular use1 Dropper ContainerSAR 8.95NCE · PrescriptionALCON LABORATORIESWithdrawn by MAH · Not Marketed
ISOPTO CARPINE 1% EYE DROPS1 %Eye drops, solution · Ocular use1 Dropper ContainerSAR 9.95Generic · PrescriptionALCON COUVREURWithdrawn by MAH · Not Marketed
ISOPTO CARPINE 4% EYE DROPS4 %Eye drops, solution · Ocular use1 Dropper ContainerSAR 10.35Generic · PrescriptionALCON COUVREURWithdrawn by MAH · Not Marketed
MINIMS PILOCARPINE 2%2 %Eye drops, solution · Ophthalmic use20 Single Dose ContainerSAR 22.35Generic · PrescriptionCHAUVIN BAUSCH & LOMBWithdrawn by regulatory authority · Not Marketed
PILOTINA-22 %Eye drops, solution · Ocular use1 Dropper ContainerSAR 6.30Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
PILOTINA-44 %Eye drops, solution · Ocular use1 Dropper ContainerSAR 8.75Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

OPEN ANGLE GLUCOMA; SJOGREN'S SYNDROME

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
SALAGEN5MG; 7.5MGtablet · oralADVANZ PHARMAPrescription22 Mar 1994
PILOCARPINE HYDROCHLORIDE5MG; 7.5MGtablet · oralINNOGENIXPrescription22 Dec 2004
PILOCARPINE HYDROCHLORIDE5MG; 7.5MGtablet · oralLANNETT CO INCPrescription14 Oct 2005
PILOCARPINE HYDROCHLORIDE5MG; 7.5MGtablet · oralIMPAX LABSPrescription31 Mar 2006
ISOPTO CARPINE1%; 2%; 4%solution/drops · ophthalmicSANDOZPrescription22 Jun 2010
PILOCARPINE HYDROCHLORIDE1%; 2%; 4%solution/drops · ophthalmicRISINGPrescription27 Sep 2017
PILOCARPINE HYDROCHLORIDE5MG; 7.5MGtablet · oralQUAGENPrescription13 Aug 2019
PILOCARPINE HYDROCHLORIDE1%; 2%; 4%solution/drops · ophthalmicSOMERSET THERAPS LLCPrescription25 Nov 2019
PILOCARPINE HYDROCHLORIDE1%; 2%; 4%solution/drops · ophthalmicAMNEALPrescription21 Sep 2020
QLOSI0.4%solution/drops · ophthalmicORASIS PHARMSPrescription17 Oct 2023
PILOCARPINE HYDROCHLORIDE1.25%solution/drops · ophthalmicAMNEALPrescription28 Apr 2025
PILOCARPINE HYDROCHLORIDE1%; 2%; 4%solution/drops · ophthalmicFDC LTDPrescription2 Oct 2025
OCUSERT PILO-205MGinsert, extended release · ophthalmicEPIC PHARMA LLCDiscontinued29 Jul 1974
OCUSERT PILO-4011MGinsert, extended release · ophthalmicEPIC PHARMA LLCDiscontinued29 Jul 1974
PILOPINE HS4%gel · ophthalmicALCONDiscontinued1 Oct 1984
PILOCARPINE HYDROCHLORIDE5MGtablet · oralPADAGIS USDiscontinued16 Nov 2004
VUITY1.25%solution/drops · ophthalmicABBVIEDiscontinued28 Oct 2021

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ISOPTO CARPINE000008682 %SOLUTION · OPHTHALMICNOVARTIS PHARMACEUTICALS CANADA INC
JAMP PILOCARPINE025095715 MGTABLET · ORALJAMP PHARMA CORPORATION
M-PILOCARPINE024961195 MGTABLET · ORALMANTRA PHARMA INC
MINIMS PILOCARPINE NITRATE021484632 % / W/VDROPS · OPHTHALMICBAUSCH & LOMB INC
SALAGEN022163455 MGTABLET · ORALAMDIPHARM LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPILOCARPINE 1% EYE DROPS$3.44852per ML23 Sep 2026
US NADACPILOCARPINE 2% EYE DROPS$2.81441per ML23 Sep 2026
US NADACPILOCARPINE 4% EYE DROPS$3.37591per ML23 Sep 2026
US NADACPILOCARPINE HCL 1.25% EYE DROP$24.74per ML23 Sep 2026
US NADACPILOCARPINE HCL 1.25% EYE DROP$19.39133per ML23 Sep 2026
US NADACPILOCARPINE HCL 5 MG TABLET$0.33849per EA23 Sep 2026
US NADACPILOCARPINE HCL 7.5 MG TABLET$0.35404per EA23 Sep 2026
US NADACVUITY 1.25% EYE DROP$31.3936per ML23 Sep 2026
US NADACVUITY 1.25% EYE DROP$23.39475per ML23 Sep 2026
NHS Drug TariffPilocarpine 5mg tablets£41.1484 tablet1 Oct 2026
NHS Drug TariffPilocarpine hydrochloride 1% eye drops£32.1010 ml1 Oct 2026
NHS Drug TariffPilocarpine hydrochloride 2% eye drops£110.4710 ml1 Oct 2026
NHS Drug TariffPilocarpine hydrochloride 4% eye drops£69.1010 ml1 Oct 2026
NHS Drug TariffPilocarpine nitrate 2% eye drops 0.5ml unit dose preservative free£14.6520 unit dose1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 21.4. Ophthalmological preparations > Miotics and antiglaucoma medicines · core
    Acute angle closure with pupillary block; Ocular hypertension; Primary open-angle glaucoma
    Local > Ophthalmological > Solution (eye drops): 2% (hydrochloride or nitrate); 4% (hydrochloride or nitrate)

Safety signals and safety-related labeling changes

  • US FDA 6 Apr 2023 VUITY — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pilocarpine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.