Estradiol

Treats Moderate. Sold as Estraderm, Vivelle, Climara, Menostar, Fempatch and 12 more. Every FDA application for this active ingredient: 19 branded and 43 generic.

As of Nov 14, 2026, FDA lists 62 applications for Estradiol (sold as Estraderm, Vivelle, Climara and others), first approved Sep 10, 1986, with 10 new uses approved and 1 published complete response letter.

First approved: Sep 10, 1986
Applications: 62
New uses approved: 10
Complete response letters: 1
Medicare spending, 2025: $446M

Medicare Spending

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


Estradiol	Part D	$243M	+12%	2,010,186
Estring	Part D	$52.7M	+7%	34,103
Estradiol (Twice Weekly)	Part D	$46.2M	+51%	133,141
Yuvafem	Part D	$32.3M	+6%	89,746
Estradiol (Once Weekly)	Part D	$22.2M	+21%	69,747
Dotti	Part D	$14.0M	+5%	46,494
Imvexxy	Part D	$11.6M	-15%	8,251
Femring	Part D	$7.2M	+3%	2,771
Lyllana	Part D	$4.2M	+51%	17,312
Climara	Part D	$3.2M	+4%	6,895
Vagifem	Part D	$3.1M	+1%	2,515
Vivelle-Dot	Part D	$2.4M	-25%	2,112
Estrace	Part D	$1.2M	-37%	1,988
Minivelle	Part D	$681K	-47%	733
Menostar	Part D	$603K	0%	448
Elestrin	Part D	$521K	+86%	731
Divigel	Part D	$480K	-23%	463
Evamist	Part D	$422K	+12%	642
Estrogel	Part D	$0K	-100%	0

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

ESTRADIOL 0.01% CREAM: $0.476 per GMGeneric · +4% in a year
ESTRADIOL 0.025 MG PATCH(1/WK): $12.33 per unitGeneric · +11% in a year
ESTRADIOL 0.025 MG PATCH(2/WK): $8.01 per unitGeneric · +27% in a year
ESTRADIOL 0.0375 MG PATCH(1/WK): $12.78 per unitGeneric · +18% in a year
ESTRADIOL 0.0375 MG PATCH(2/WK): $8.26 per unitGeneric · +18% in a year
ESTRADIOL 0.05 MG PATCH (1/WK): $12.22 per unitGeneric · +0% in a year
ESTRADIOL 0.05 MG PATCH (2/WK): $8.61 per unitGeneric · +15% in a year
ESTRADIOL 0.06 MG PATCH (1/WK): $12.27 per unitGeneric · +6% in a year
ESTRADIOL 0.06% 1.25G GEL PUMP: $3.31 per GMGeneric · -6% in a year
ESTRADIOL 0.075 MG PATCH(1/WK): $13.32 per unitGeneric · -5% in a year
ESTRADIOL 0.075 MG PATCH(2/WK): $8.23 per unitGeneric · +20% in a year
ESTRADIOL 0.1 MG PATCH (1/WK): $12.78 per unitGeneric · +6% in a year

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

l'estrogelA drug with a new indication and a new dosage for adjusting the start timing of controlled ovarian stimulation in assisted reproductive technology and… · Fuji Pharma Co., Ltd. · Mar 11, 2022
JulinaA drug with a new indication and a new dosage for adjusting the start timing of controlled ovarian stimulation in assisted reproductive technology and… · Bayer Yakuhin, Ltd. · Mar 11, 2022
DivigelA drug with a new indication and a new dosage for adjusting the start timing of controlled ovarian stimulation in assisted reproductive technology and… · Sun Pharma Japan Ltd. · Mar 11, 2022
Estrana(1) A drug with a new indication and a new dosage for adjusting the start timing of controlled ovarian stimulation in assisted reproductive technology and… · Hisamitsu Pharmaceutical Co., Inc. · Mar 11, 2022
EstranaA drug with a new additional indication and new dosages for the treatment of hypoestrogenism caused by hypogonadism, gonadectomy or primary ovarian… · Hisamitsu Pharmaceutical Co., Inc. · Feb 21, 2014
L'estrogelA drug with a new dosage. · Shiseido Company, Limited · Nov 25, 2011
Julina, new approvalA drug with a new route of administration indicated for the treatment of vasomotor symptoms (hot flushes and sweating) and vaginal atrophy symptoms… · Bayer Yakuhin, Ltd. · Apr 16, 2008

Clinical Trials

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


A Phase I Dose Escalation Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid TumorsAdvanced Solid Tumors, Breast Cancer · Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd.	Phase 1	Recruiting	Nov 6, 2026
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With ObesityObesity, Morbid, Postmenopause · Kasr El Aini Hospital	—	Not yet recruiting	Nov 5, 2026
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability PilotVestibulodynia, Vulvodynia · HerAccess ApS	Not applicable	Not yet recruiting	Nov 2, 2026
A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast CancerBreast Cancer, Hormone-receptor-positive Breast Cancer · Prelude Therapeutics Incorporated	Phase 1	Recruiting	Oct 29, 2026
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid TumorsAdvanced Breast Cancer, Advanced or Metastatic Breast Cancer · Pfizer	Phase 1	Not yet recruiting	Oct 27, 2026
Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast CancerMetastatic Breast Cancer (MBC), HER2-Positive Breast Cancer · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 3	Not yet recruiting	Oct 23, 2026
Post-traumatic Estradiol Administration and Care Evaluation (PEACE)Chronic Musculoskeletal Pain, Sexual Assault · University of North Carolina, Chapel Hill	Phase 2	Not yet recruiting	Oct 9, 2026
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast CancerAdvanced or Metastatic Breast Cancer · Genentech, Inc.	Phase 1	Not yet recruiting	Oct 9, 2026

Applications

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


Jul 23, 1975	EstraceANDA 84500	Bristol Myers Squibb	22	Discontinued
Jul 28, 1975	EstraceANDA 84499	Bristol Myers Squibb	21	Discontinued
Jan 31, 1984	EstraceANDA 86069	Abbvie	17	Marketed
Sep 10, 1986	EstradermNDA 19081 · New dosage form	Novartis	35	Discontinued
Jun 30, 1993	EstraceANDA 81295	Bristol Myers Squibb	11	Discontinued
Oct 28, 1994	VivelleNDA 20323 · New dosage form	Sandoz	33	Discontinued
Dec 22, 1994	Climara, MenostarNDA 20375 · New formulation or manufacturer	Bayer Hlthcare	35	Marketed
Mar 14, 1996	EstradiolANDA 40114	Rubicon Research	13	Discontinued
Apr 26, 1996	EstringNDA 20472 · New dosage form	Pfizer	13	Marketed
Jul 31, 1996	Estradiol, Vivelle-DotNDA 20538 · New formulation or manufacturer	Sandoz	30	Marketed
Dec 3, 1996	FempatchNDA 20417 · New dosage form	Parke Davis	2	Discontinued
Dec 20, 1996	AloraNDA 20655 · New formulation or manufacturer	Abbvie	14	Discontinued
Oct 22, 1997	EstradiolANDA 40197	Barr Labs Inc	12	Marketed
Dec 29, 1997	GynodiolANDA 40212	Duramed Pharms Barr	6	Discontinued
Jan 30, 1998	EstradiolANDA 40138	Lannett Co Inc	3	Discontinued
Aug 4, 1998	EsclimNDA 20847 · New dosage form	Women First Hlthcare	4	Discontinued
Dec 29, 1998	EstradiolANDA 40275	Epic Pharma LLC	6	Marketed
Mar 26, 1999	VagifemNDA 20908 · New dosage form	Novo Nordisk Inc	21	Marketed
Apr 21, 1999	EstradiolANDA 40326	Pharmobedient	5	Discontinued
Sep 20, 1999	EstradiolNDA 21048 · New dosage form	Ortho Mcneil Pharm	0	Discontinued
Nov 19, 1999	InnofemANDA 40312	Novo Nordisk Inc	2	Discontinued
Feb 24, 2000	EstradiolANDA 75182	Mylan Technologies	17	Marketed
Feb 24, 2000	EstradiolANDA 75233	Mylan Technologies	9	Marketed
Aug 16, 2000	VivelleNDA 21167 · New indication	Novartis	0	Marketed
Apr 5, 2002	AloraNDA 21310 · New indication	Watson Labs	0	Marketed
Apr 17, 2002	EstradiolANDA 40297	Usl Pharma	0	Discontinued
Feb 9, 2004	EstrogelNDA 21166 · New dosage form	Ascend Theraps US	12	Marketed
Jun 8, 2004	MenostarNDA 21674 · TYPE 6	Bayer Hlthcare	0	Marketed
Dec 15, 2006	ElestrinNDA 21813 · New formulation or manufacturer	Viatris	7	Marketed
Jun 4, 2007	DivigelNDA 22038 · New formulation or manufacturer	Vertical Pharms	9	Marketed
Jul 27, 2007	EvamistNDA 22014 · New formulation or manufacturer	Padagis US	8	Marketed
Oct 29, 2012	MinivelleNDA 203752 · New formulation or manufacturer	Noven	10	Marketed
Dec 19, 2014	EstradiolANDA 20167	Mylan Pharms Inc	0	Marketed
Dec 19, 2014	EstradiolANDA 201675	Mylan Technologies	4	Marketed
May 29, 2015	EstradiolANDA 205256	Amneal Pharms	5	Marketed
Jul 21, 2017	EstradiolANDA 206388	Teva Pharms USA	4	Marketed
Dec 29, 2017	EstradiolANDA 208788	Mylan	2	Marketed
Jan 22, 2018	EstradiolANDA 210194	Padagis Israel	2	Marketed
Mar 5, 2018	EstradiolANDA 209767	Encube	3	Marketed
Mar 30, 2018	EstradiolANDA 210488	Teva Pharms USA	2	Marketed
May 29, 2018	ImvexxyNDA 208564 · New formulation or manufacturer	Mayne Pharma	3	Marketed
Aug 15, 2018	EstradiolANDA 206685	Mylan Technologies	2	Marketed
Sep 14, 2018	EstradiolANDA 210264	Glenmark Pharms Ltd	4	Marketed
Feb 5, 2019	EstradiolANDA 211293	Amneal	2	Marketed
Sep 28, 2020	EstradiolANDA 211396	Amneal	2	Marketed
Jul 15, 2021	EstradiolANDA 212313	Prasco	3	Marketed
Aug 10, 2022	EstradiolANDA 211783	Xiromed	0	Marketed
Dec 1, 2022	EstradiolANDA 206241	Zydus Pharms	1	Marketed
Mar 29, 2023	EstradiolANDA 202985	Zydus Pharms	1	Marketed
Apr 17, 2023	EstradiolANDA 204379	Zydus Pharms	1	Marketed
Aug 24, 2023	EstradiolANDA 217610	Novitium Pharma	1	Marketed
Sep 6, 2023	EstradiolANDA 217334	Novitium Pharma	0	Marketed
Nov 14, 2023	EstradiolANDA 216524	Padagis Israel	1	Marketed
Apr 22, 2024	EstradiolANDA 216160	Solaris Pharma Corp	0	Marketed
Jul 12, 2024	EstradiolANDA 216055	Amneal	0	Marketed
Jul 12, 2024	EstradiolANDA 217863	Amvika	0	Marketed
Aug 2, 2024	EstradiolANDA 216550	Aurobindo Pharma	0	Marketed
Oct 23, 2024	EstradiolANDA 217882	Novitium Pharma	0	Marketed
Mar 5, 2025	EstradiolANDA 218507	Encube	1	Marketed
Dec 8, 2025	EstradiolANDA 214137	Teva Pharms USA Inc	0	Marketed
Feb 2, 2026	EstradiolANDA 215096	Padagis US	0	Discontinued
May 11, 2026	EstradiolANDA 218214	Encube	0	Marketed

Show all 62

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
May 5, 2017	EstradiolClinical Safety	Approved

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