Estradiol; Progesterone

Sold as Bijuva. Every FDA application for this active ingredient: 1 branded and 1 generic.

As of Nov 15, 2026, FDA lists 2 applications for Estradiol; Progesterone (sold as Bijuva), first approved Oct 28, 2018, with 1 new use approved and 0 published complete response letters.

First approved: Oct 28, 2018
Applications: 2
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $826K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Bijuva	Part D	$826K	+13%	552

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

BIJUVA 0.5 MG-100 MG CAPSULE: $8.83 per unitBrand · +5% in a year
BIJUVA 1 MG-100 MG CAPSULE: $8.53 per unitBrand · +5% in a year

Clinical Trials

57 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Cycle-to-cycle Variability of Progesterone in the Endometrium in Patients Undergoing an Euploid Blastocyst Transfer in a Hormone Replacement Therapy (HRT) Cycle (PROMICOFET)Fertility, Implantation, Embryo · University Hospital, Ghent	Phase 4	Not yet recruiting	Sep 14, 2026
Hormone thERapy Effects on BRAin-HEART Health During the Menopausal TransitionMenopause, Perimenopause · McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4	Not yet recruiting	Jul 29, 2026
Endometrial Peristalsis and Pregnancy Outcomes in Hormone Replacement Therapy (HRT) - Frozen Embryo Transfer (FET) CyclesInfertility, Endometrial Peristalsis · Mỹ Đức Hospital	—	Recruiting	Jun 30, 2026
The Role of Estradiol and Progesterone on Appetite Regulation and Energy BalanceEnergy Balance, Physiology - Regulation of Appetite and Food Intake · Wilfrid Laurier University	Not applicable	Recruiting	Jun 2, 2026
Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite AthletesSafety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes · Enhanced Emirates Limited	Not applicable	Enrolling by invitation	May 6, 2026
Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer OutcomesIVF, Infertility, Female · Beni-Suef University	Phase 4	Recruiting	Mar 30, 2026
Effect of Pentoxyfilline on Endometrial Thickness and Frozen Embryo Transfer OutcomesEmbryo Transfer, IVF · Beni-Suef University	Phase 3	Recruiting	Mar 30, 2026
Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone TherapyMenopausal Women, Menopausal Symptom Relief · Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital	Not applicable	Not yet recruiting	Mar 27, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 28, 2018	BijuvaNDA 210132 · New combination	Mayne Pharma	5	Marketed
May 16, 2022	Estradiol And ProgesteroneANDA 214293	Amneal Pharms	1	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA