Regulatory PathRegulatory requirements compared

Active substances

Estradiol + Progesterone

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
BIJUVA1MG;100MG; 0.5MG;100MGcapsule · oralMAYNE PHARMAPrescription28 Oct 2018
ESTRADIOL AND PROGESTERONE1MG;100MGcapsule · oralAMNEAL PHARMSDiscontinued16 May 2022

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BIJUVA02505223100 MG; 1 MGCAPSULE · ORALKNIGHT THERAPEUTICS INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACBIJUVA 0.5 MG-100 MG CAPSULE$8.84931per EA1 Jun 2026
US NADACBIJUVA 1 MG-100 MG CAPSULE$8.53176per EA1 Jun 2026
NHS Drug TariffEstradiol 1mg / Progesterone 100mg capsules£8.1428 capsule1 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.