Estrogens, Conjugated

Treats Moderate. Sold as Premarin. Every FDA application for this active ingredient: 4 branded and 2 generic.

As of Nov 15, 2026, FDA lists 6 applications for Estrogens, Conjugated (sold as Premarin), first approved May 8, 1942, with 3 new uses approved and 0 published complete response letters.

First approved: May 8, 1942
Applications: 6
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $236M

Medicare Spending

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


Premarin	Part D	$235M	-8%	212,281
Conjugated Estrogens	Part D	$1.3M	New	3,635
Premarin	Part B	$27K	-1%	99

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

PREMARIN 0.3 MG TABLET: $6.95 per unitBrand · +3% in a year
PREMARIN 0.45 MG TABLET: $6.95 per unitBrand · +3% in a year
PREMARIN 0.625 MG TABLET: $6.94 per unitBrand · +3% in a year
PREMARIN 0.9 MG TABLET: $6.93 per unitBrand · +3% in a year
PREMARIN 1.25 MG TABLET: $6.95 per unitBrand · +3% in a year

Clinical Trials

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


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
Neoadjuvant Dalpiciclib + AI → SHR-A1811 for HR+/HER2-Low Breast CancerBreast Cancer, HR Positive/HER2 Low Breast Cancer · Tang-Du Hospital	Phase 2	Not yet recruiting	Jun 1, 2026
A Study of Single Dose of BL0175 in Postmenopausal WomenPostmenopausal Women · Shanghai Best-Link Bioscience, LLC	Phase 1	Not yet recruiting	Jan 26, 2026
ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast CancerMetastatic Breast Cancer, HER2 Low Breast Carcinoma · Kristina A. Fanucci	Phase 1 / Phase 2	Recruiting	Sep 30, 2025
A Clinical Study of SYS6023 in Patients With Advanced Solid TumorsAdvanced Solid Tumor · CSPC Megalith Biopharmaceutical Co.,Ltd.	Phase 1	Recruiting	Aug 8, 2025
Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse SurgeryPelvic Organ Prolapse (POP) · Sarah Wozney	Phase 3	Recruiting	Jun 22, 2025
Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive BladderEffect of Drug, Urinary Bladder, Overactive · Mackay Memorial Hospital	Phase 4	Recruiting	Jun 28, 2024
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast CancerBreast Cancer Female, Breast Cancer · Dana-Farber Cancer Institute	Phase 2	Recruiting	Jun 3, 2024

Applications

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


May 8, 1942	PremarinNDA 4782 · New molecular entity	Wyeth Pharms	75	Marketed
Dec 18, 1956	PremarinNDA 10402 · New dosage form	Wyeth Pharms	23	Marketed
Oct 16, 1978	PremarinNDA 20216	Wyeth Pharms	39	Marketed
Jul 16, 2003	PremarinNDA 21417 · TYPE 6	Wyeth Pharms Inc	0	Marketed
Oct 15, 2025	Conjugated EstrogensANDA 214023	Novast Labs	0	Marketed
Oct 15, 2025	Conjugated EstrogensANDA 214025	Novast Labs	0	Marketed

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