Regulatory PathRegulatory requirements compared

Active substance

Estradiol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ESTRADERM MX-1008 mgTransdermal patch · Topical6 BoxSAR 39.05NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
ESTRADERM MX-252 mgTransdermal patch · Topical6 BoxSAR 18.65NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
ESTRADERM MX-504 mgTransdermal patch · Topical6 BoxSAR 26.95NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
VAGIFEM 25MICROGRAM- VAGINAL TAB25 µgTablet · Vaginal use15 ApplicatorSAR 32.25NCE · PrescriptionNOVO NORDISKWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
DELESTROGEN10MG/ML; 20MG/MLinjectable · injectionPH HEALTHPrescription15 Jul 1954
DEPO-ESTRADIOL5MG/MLinjectable · injectionPFIZERPrescription15 Aug 1979
ESTRACE0.01%cream · vaginalABBVIEPrescription31 Jan 1984
CLIMARA0.05MG/24HR; 0.1MG/24HR; 0.075MG/24HR; 0.025MG/24HR; 0.0375MG/24HR; 0.06MG/24HRfilm, extended release · transdermalBAYER HLTHCAREPrescription22 Dec 1994
MENOSTAR0.014MG/24HRfilm, extended release · transdermalBAYER HLTHCAREPrescription22 Dec 1994
ESTRING0.0075MG/24HRinsert, extended release · vaginalPFIZERPrescription26 Apr 1996
VIVELLE-DOT0.0375MG/24HR; 0.05MG/24HR; 0.075MG/24HR; 0.1MG/24HR; 0.025MG/24HRsystem · transdermalSANDOZPrescription31 Jul 1996
ESTRADIOL0.5MG; 1MG; 2MGtablet · oralBARR LABS INCPrescription22 Oct 1997
ESTRADIOL0.5MG; 1MG; 2MGtablet · oralEPIC PHARMA LLCPrescription29 Dec 1998
VAGIFEM10MCGtablet · vaginalNOVO NORDISK INCPrescription26 Mar 1999
ESTRADIOL0.1MG/24HR; 0.075MG/24HR; 0.025MG/24HR; 0.0375MG/24HR; 0.06MG/24HR; 0.05MG/24HRfilm, extended release · transdermalMYLAN TECHNOLOGIESPrescription24 Feb 2000
ESTRADIOL0.05MG/24HRfilm, extended release · transdermalMYLAN TECHNOLOGIESPrescription24 Feb 2000
VIVELLE0.05MG/24HR; 0.1MG/24HRfilm, extended release · transdermalNOVARTISPrescription16 Aug 2000
ALORAN/Afilm, extended release · transdermalWATSON LABSPrescription5 Apr 2002
FEMRINGEQ 0.05MG BASE/24HR; EQ 0.1MG BASE/24HRinsert, extended release · vaginalMILLICENT MFG PRPrescription20 Mar 2003
ESTROGEL0.06% (1.25GM/ACTIVATION)gel, metered · transdermalASCEND THERAPS USPrescription9 Feb 2004
MENOSTAR0.014MG/24HRsystem · transdermalBAYER HLTHCAREPrescription8 Jun 2004
ELESTRIN0.06% (0.87GM/ACTIVATION)gel, metered · transdermalVIATRISPrescription15 Dec 2006
DIVIGEL0.1% (0.25GM/PACKET); 0.1% (0.5GM/PACKET); 0.1% (1GM/PACKET); 0.1% (0.75GM/PACKET); 0.1% (1.25GM/PACKET)gel · transdermalVERTICAL PHARMSPrescription4 Jun 2007
EVAMIST1.53MG/SPRAYspray · transdermalPADAGIS USPrescription27 Jul 2007
ESTRADIOL VALERATE20MG/ML; 40MG/MLinjectable · injectionAM REGENTPrescription19 Jan 2010
MINIVELLE0.0375MG/24HR; 0.075MG/24HR; 0.05MG/24HR; 0.1MG/24HR; 0.025MG/24HRfilm, extended release · transdermalNOVENPrescription29 Oct 2012
ESTRADIOL0.025MG/DAY; 0.0375MG/DAY; 0.05MG/DAY; 0.075MG/DAY; 0.1MG/DAYsystem · transdermalMYLAN PHARMS INCPrescription19 Dec 2014
ESTRADIOL0.025MG/24HR; 0.0375MG/24HR; 0.05MG/24HR; 0.075MG/24HR; 0.1MG/24HRsystem · transdermalMYLAN TECHNOLOGIESPrescription19 Dec 2014
ESTRADIOL10MCGtablet · vaginalAMNEAL PHARMSPrescription29 May 2015

58 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CLIMARA 250224749925 MCG / 24 HOURPATCH · TRANSDERMALBAYER INC
CLIMARA 500223150950 MCG / 24 HOURPATCH · TRANSDERMALBAYER INC
CLIMARA 750224750075 MCG / 24 HOURPATCH · TRANSDERMALBAYER INC
DIVIGEL024248350.1 %GEL · TRANSDERMALSEARCHLIGHT PHARMA INC
DIVIGEL024248430.1 %GEL · TRANSDERMALSEARCHLIGHT PHARMA INC
DIVIGEL024249240.1 %GEL · TRANSDERMALSEARCHLIGHT PHARMA INC
ESTRADOT 10002244002100 MCG / 24 HOURPATCH · TRANSDERMALSANDOZ CANADA INCORPORATED
ESTRADOT 250224567625 MCG / 24 HOURPATCH · TRANSDERMALSANDOZ CANADA INCORPORATED
ESTRADOT 37.50224399937.5 MCG / 24 HOURPATCH · TRANSDERMALSANDOZ CANADA INCORPORATED
ESTRADOT 500224400050 MCG / 24 HOURPATCH · TRANSDERMALSANDOZ CANADA INCORPORATED
ESTRADOT 750224400175 MCG / 24 HOURPATCH · TRANSDERMALSANDOZ CANADA INCORPORATED
ESTRING021688982 MGRING (SLOW-RELEASE) · VAGINALPFIZER CANADA ULC
ESTROGEL022387040.06 % / W/WGEL · TRANSDERMALORGANON CANADA INC.
IMVEXXY025036894 MCG / INSERTINSERT · VAGINALKNIGHT THERAPEUTICS INC.
IMVEXXY0250369710 MCG / INSERTINSERT · VAGINALKNIGHT THERAPEUTICS INC.
LUPIN-ESTRADIOL024490480.5 MGTABLET · ORALLUPIN PHARMA CANADA LIMITED
LUPIN-ESTRADIOL024490561 MGTABLET · ORALLUPIN PHARMA CANADA LIMITED
LUPIN-ESTRADIOL024490642 MGTABLET · ORALLUPIN PHARMA CANADA LIMITED
SANDOZ ESTRADIOL DERM 10002246969100 MCG / 24 HOURPATCH · TRANSDERMALSANDOZ CANADA INCORPORATED
SANDOZ ESTRADIOL DERM 500224696750 MCG / 24 HOURPATCH · TRANSDERMALSANDOZ CANADA INCORPORATED
SANDOZ ESTRADIOL DERM 750224696875 MCG / 24 HOURPATCH · TRANSDERMALSANDOZ CANADA INCORPORATED
VAGIFEM 100232546210 MCGVAGINAL TABLET · VAGINALNOVO NORDISK CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCLIMARA 0.025 MG/DAY PATCH$18.22764per EA23 Sep 2026
US NADACCLIMARA 0.0375 MG/DAY PATCH$18.29817per EA23 Sep 2026
US NADACCLIMARA 0.05 MG/DAY PATCH$18.25678per EA23 Sep 2026
US NADACCLIMARA 0.06 MG/DAY PATCH$18.14596per EA23 Sep 2026
US NADACCLIMARA 0.075 MG/DAY PATCH$18.25087per EA23 Sep 2026
US NADACCLIMARA 0.1 MG/DAY PATCH$18.27935per EA23 Sep 2026
US NADACDELESTROGEN 100 MG/5 ML VIAL$35.75275per ML23 Sep 2026
US NADACDELESTROGEN 50 MG/5 ML VIAL$25.50486per ML23 Sep 2026
US NADACDEPO-ESTRADIOL 5 MG/ML VIAL$51.90841per ML1 Jul 2026
US NADACDIVIGEL 0.25 MG GEL PACKET$5.388per EA23 Sep 2026
US NADACDIVIGEL 0.5 MG GEL PACKET$5.39183per EA23 Sep 2026
US NADACDIVIGEL 0.75 MG GEL PACKET$5.40611per EA23 Sep 2026
NHS Drug TariffEstradiol 0.06% transdermal gel (750microgram per actuation)£9.1580 gram1 Oct 2026
NHS Drug TariffEstradiol 1.53mg/dose transdermal spray£6.9056 dose1 Oct 2026
NHS Drug TariffEstradiol 1.53mg/dose transdermal spray£20.70168 dose1 Oct 2026
NHS Drug TariffEstradiol 100micrograms/24hours transdermal patches£7.284 patch1 Oct 2026
NHS Drug TariffEstradiol 100micrograms/24hours transdermal patches£5.098 patch1 Oct 2026
NHS Drug TariffEstradiol 100micrograms/24hours transdermal patches£19.9924 patch1 Oct 2026
NHS Drug TariffEstradiol 10microgram pessaries£11.5624 pessary1 Oct 2026
NHS Drug TariffEstradiol 1mg tablets£5.0684 tablet1 Oct 2026
NHS Drug TariffEstradiol 1mg transdermal gel sachets£8.5028 sachet1 Oct 2026
NHS Drug TariffEstradiol 1mg transdermal gel sachets£27.6291 sachet1 Oct 2026
NHS Drug TariffEstradiol 25micrograms/24hours transdermal patches£4.078 patch1 Oct 2026
NHS Drug TariffEstradiol 25micrograms/24hours transdermal patches£16.4624 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.

Safety signals and safety-related labeling changes

  • US FDA 12 Feb 2026 BIJUVA — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 12 Feb 2026 DIVIGEL — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 12 Feb 2026 ESTRING — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions
  • US FDA 5 May 2025 ALORA — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 10 Sep 2024 ESTRASORB — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations
  • US FDA 26 Jun 2024 NATAZIA — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 15 Feb 2024 ANGELIQ — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 15 Feb 2024 ELESTRIN — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 15 Feb 2024 ESTROGEL — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 15 Feb 2024 EVAMIST — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 15 Feb 2024 MENOSTAR — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 15 Feb 2024 VAGIFEM — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 15 Feb 2024 VIVELLE-DOT — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 15 Feb 2024 ACTIVELLA — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 15 Feb 2024 CLIMARA PRO — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for estradiol →

Combinations containing Estradiol

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.