Regulatory PathRegulatory requirements compared

Active substance

Cyclopentolate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
MINIMS CYCLOPENTOLATE HCL 0.5%0.5 %Eye drops, solution · Ophthalmic use20 Single Dose ContainerSAR 60.05NCE · PrescriptionCHAUVIN BAUSCH & LOMBValid
MINIMS CYCLOPENTOLATE HCL 1%1 %Eye drops, solution · Ophthalmic use20 Single Dose ContainerSAR 60.10Generic · PrescriptionCHAUVIN BAUSCH & LOMBValid
PENTOLATE 1% EYE DROPS1 %Eye drops · Ophthalmic use1 Dropper ContainerSAR 9.00Generic · PrescriptionAmman Pharmaceutical Industries (API)Valid
SECLODYN 1% EYE DROPS1 %Eye drops, solution · Ophthalmic use20 Single Dose ContainerSAR 49.00Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
COLIRCUSI-CICLOPLEGIC 1%1 %Eye drops, solution · Ocular use1 Dropper ContainerSAR 5.55Generic · PrescriptionALCON CUSIWithdrawn by MAH · Not Marketed
CYCLATE 0.5% EYE DROPS0.5 %Eye drops, solution · Ocular use1 Dropper ContainerSAR 11.05Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
CYCLATE 1% EYE DROPS1 %Eye drops, solution · Ocular use1 Dropper ContainerSAR 13.10Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
CYCLATE 2% EYE DROPS2 %Eye drops, solution · Ocular use1 Dropper ContainerSAR 20.00Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
CYCLOGYL EYE DROPS 1%1 %Eye drops, solution · Ophthalmic use1 Dropper ContainerSAR 15.35Generic · PrescriptionALCON LABORATORIESWithdrawn by MAH · Not Marketed
CYCLOGYL EYE DROPS 2%2 %Eye drops, solution · Ocular use1 Dropper ContainerSAR 26.20Generic · PrescriptionALCON LABORATORIESWithdrawn by MAH · Not Marketed
CYCLOPENTOLATE 0.5%THILO EYE DROPS0.5 %Eye drops · Ophthalmic use1 Dropper ContainerSAR 9.30Generic · PrescriptionDR. THILO LABORATORIESWithdrawn by MAH · Not Marketed
CYCLOPENTOLATE 1% THILO EYE DROPS1 %Eye drops · Ophthalmic use1 Dropper ContainerSAR 10.80Generic · PrescriptionDR. THILO LABORATORIESWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

NON-INFECTIOUS UVEITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
CYCLOGYL2%solution/drops · ophthalmicALCON LABS INCPrescription31 Jul 1974
CYCLOGYL0.5%solution/drops · ophthalmicALCON LABS INCPrescription31 Jul 1974
CYCLOGYL1%solution/drops · ophthalmicALCON LABS INCPrescription31 Jul 1974
PENTOLAIR1%solution/drops · ophthalmicBAUSCH AND LOMB INCPrescription29 Apr 1994
AKPENTOLATE1%solution/drops · ophthalmicRISINGPrescription13 Jan 1997
AKPENTOLATE2%solution/drops · ophthalmicRISINGPrescription13 Jan 1997
CYCLOPENTOLATE HYDROCHLORIDE1%solution/drops · ophthalmicSOLA BARNES HINDDiscontinued22 Nov 1974
AK-PENTOLATE1%solution/drops · ophthalmicEPIC PHARMA LLCDiscontinued10 Apr 1979
CYCLOPENTOLATE HYDROCHLORIDE1%solution/drops · ophthalmicALCON PHARMS LTDDiscontinued24 Jan 1991
CYCLOPENTOLATE HYDROCHLORIDE0.5%solution/drops · ophthalmicSCIEGEN PHARMSDiscontinued9 Dec 2015
CYCLOPENTOLATE HYDROCHLORIDE1%solution/drops · ophthalmicSOLA BARNES HINDDiscontinued
PENTOLAIR1%solution/drops · ophthalmicPHARMAFAIRDiscontinued
PENTOLAIR0.5%solution/drops · ophthalmicPHARMAFAIRDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CYCLOGYL002525061 % / W/VDROPS · OPHTHALMICALCON CANADA INC
MINIMS CYCLOPENTOLATE HYDROCHLORIDE021483821 % / W/VSOLUTION · OPHTHALMICBAUSCH & LOMB INC
ODAN-CYCLOPENTOLATE006266271 %SOLUTION · OPHTHALMICODAN LABORATORIESLTD

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCYCLOGYL 0.5% EYE DROPS$6.40467per ML23 Sep 2026
US NADACCYCLOGYL 2% EYE DROPS$22.096per ML23 Sep 2026
US NADACCYCLOGYL 2% EYE DROPS$14.6264per ML23 Sep 2026
US NADACCYCLOPENTOLATE 1% EYE DROP$0.86977per ML23 Sep 2026
US NADACCYCLOPENTOLATE 1% EYE DROPS$2.64533per ML23 Sep 2026
US NADACCYCLOPENTOLATE 1% EYE DROPS$0.86977per ML23 Sep 2026
NHS Drug TariffCyclopentolate 0.5% eye drops£8.085 ml1 Oct 2026
NHS Drug TariffCyclopentolate 0.5% eye drops 0.5ml unit dose preservative free£13.4120 unit dose1 Oct 2026
NHS Drug TariffCyclopentolate 1% eye drops£8.085 ml1 Oct 2026
NHS Drug TariffCyclopentolate 1% eye drops 0.5ml unit dose preservative free£13.7120 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)

  • 14.1. Diagnostic agents > Ophthalmic medicines · core
    Therapeutic equivalent to tropicamide for Cycloplegic drug
  • 21.5. Ophthalmological preparations > Mydriatics · core
    Therapeutic equivalent to atropine for Anterior uveitis

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.