Regulatory PathRegulatory requirements compared

Active substances

Ethinylestradiol + Norelgestromin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
EVRA TRANSDERMAL PATCHES0.6,6 mg,mgTransdermal patch · Topical3 BoxSAR 37.25Generic · PrescriptionGEDEON RICHTERValid
Indications — CHI Daman Drug Formulary

CONTRACEPTION; ENDOMETRIOSIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
XULANE0.035MG/24HR;0.15MG/24HRfilm, extended release · transdermalMYLAN TECHNOLOGIESPrescription16 Apr 2014
ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRfilm, extended release · transdermalAMNEALPrescription25 Feb 2021
ONSURA0.035MG/24HR;0.15MG/24HRfilm, extended release · transdermalTEVA PHARMS USAPrescription25 Aug 2021
ETHINYL ESTRADIOL AND NORELGESTROMIN0.035MG/24HR;0.15MG/24HRfilm, extended release · transdermalZYDUS PHARMSPrescription14 Sep 2023
GWYN LO0.02MG/24HR;0.22MG/24HRsystem · transdermalVIATRIS SPECIALTYPrescription28 Jul 2026
ORTHO EVRA0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**film, extended release · transdermalJANSSEN PHARMSDiscontinued20 Nov 2001

EMA European Union — centrally authorised medicines

Evra Gedeon Richter Plc. · Authorised · authorised 22 Aug 2002 · ATC G03AA13

Therapeutic indication (EMA)

Female contraception. Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
EVRA02248297200 MCG / 24 HOUR; 35 MCG / 24 HOURPATCH (EXTENDED-RELEASE) · TRANSDERMALSEARCHLIGHT PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACXULANE 150-35 MCG/DAY PATCH$37.15513per EA23 Sep 2026
NHS Drug TariffEthinylestradiol 33.9micrograms/24hours / Norelgestromin 203micrograms/24hours transdermal patches£19.519 patch1 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.

Components

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.