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ESTROGEL

NDA

ESTRADIOL | N021166 | ASCEND THERAPEUTICS US LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

407 trials from ClinicalTrials.gov — 16 recruiting, 7 active, 289 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Role of Estrogen in the Neurobiology of Eating Disorders NCT03740204	Phase 2	Active	Massachusetts General Hospital	120	2019-06-13 → 2026-12-31
Estrogen Administration for the Treatment of NASH in Postmenopausal Women NCT04833140	Phase 3	Active	Massachusetts General Hospital	50	2021-12-02 → 2027-07-09
Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Diabetes NCT06715514	N/A	Active	Lia Bally	96	2025-02-18 → 2026-12-31
Estradiol in Treating Patients With ER Beta Positive, Triple Negative Locally Advanced or Metastatic Breast Cancer NCT03941730	Phase 2	Active	Mayo Clinic	8	2019-08-28 → 2026-12-31
Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease NCT00080756	Phase 2	Active	City of Hope Medical Center	11	2004-03-11 → 2024-10-15
A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers NCT02238808	Phase 2	Active	AHS Cancer Control Alberta	19	2015-08 → 2028-06
Analysis of the Hormonal Implant and Transdermal Estradiol Gel in Climacteric Women NCT07754630	Phase 2	Active	Nutrindo Ideais Research Center	50	2025-02-25 → 2027-10-01
Pre-pubertal Low Dose Transdermal Estradiol in Turner Syndrome NCT07784582	Phase 2	Not Yet Recruiting	Children's National Research Institute	15	2026-09-01 → 2027-06
Acute Effects of Estradiol Administration on Brain Function During Fear Learning NCT07737613	Early Phase 1	Not Yet Recruiting	University of Arizona	30	2026-08 → 2027-12
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV NCT07526948	Phase 4	Not Yet Recruiting	Albert Einstein College of Medicine	62	2026-09 → 2029-10-14

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Medicare Part D Spending

CMS annual spending data for Estrogel (2024)

Total Spending

$743K

Total Claims

3,339

Beneficiaries

1,253

Avg Cost/Unit

$3.08

Spending Trend

$399K(2020)→$686K(2021)→$893K(2022)→$1.1M(2023)→$743K(2024)

YoY Change:-0.6%

5yr CAGR:+4.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs19 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

ASPEN OSS BVESTRADIOL

DMF 38291980

GEDEON RICHTER PLCESTRADIOL USP

DMF 40661981

BAYER AGESTRADIOL

DMF 46841982

KINDEVA DRUG DELIVERY LPESTRADIOL TRANSDERMAL DRUG DELIVERY SYSTEM

DMF 98411992

VALDEPHARMESTRADIOL HEMIHYDRATE

DMF 229722009

VALDEPHARMESTRADIOL BENZOATE

DMF 238362010

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDESTRADIOL HEMIHYDRATE USP, NON-STERILE, BULK DRUG SUBSTANCE

DMF 239422010

LUPIN LTDESTRADIOL HEMIHYDRATE USP

DMF 258162012

SYMBIOTEC PHARMALAB PRIVATE LTDESTRADIOL HEMIHYDRATE USP

DMF 341472019

ASPEN OSS BVESTRADIOL 3-ACETATE

DMF 347382020

SCHERING AGInactiveESTRADIOL ENANTHATE

DMF 10931967

ORTHO PHARMACEUTICAL CORPInactiveESTRADIOL 17-A-IN PROPYLENE GLYCOL : PARENTERAL

DMF 16551971

ROUSSEL CORPInactiveESTRADIOL BENZOATE

DMF 22911974

ORGANON INCInactiveESTRADIOL

DMF 26771976

MITSUBISHI CHEMICAL INDUSTRIES LTDInactiveESTRADIOL

DMF 31751978

DIOSYNTH BVInactiveESTRADIOL BENZOATE

DMF 35801979

MEDIMPEX NORTHAMERICA INCInactiveESTRADIOL DIPROPIONATE

DMF 40731981

DIOSYNTH BVInactiveESTRADIOL VALERATE MICRO

DMF 42671981

ROUSSELL UCLAFInactiveESTRADIOL USP

DMF 56861985

DR REDDYS LABORATORIES LTDInactiveESTRADIOL

DMF 69461987

ROUSSELL UCLAFInactiveESTRADIOL

DMF 88191990

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveESTRADIOL

DMF 105361993

CYGNUS INCInactiveESTRADIOL TRANSDERMAL DELIVERY SYSTEM (E2 III TDS)

DMF 106511993

NV ORGANONInactiveESTRADIOL BENZOATE

DMF 150852000

DIOSYNTH BVInactiveESTRADIOL GLUCOSIDE

DMF 157592001

MILLICENT HOLDINGS LTDInactiveESTRADIOL 3 ACETATE

DMF 161202002

CATALENT PHARMA SOLUTIONS LLCInactiveESTRADIOL VAGINAL SOFT GELATIN CAPSULES

DMF 228432009

BEIJING KEYIFENG BIOTECH DEVELOPMENT CO LTDInactiveESTRADIOL USP, NON-STERILE, BULK DRUG

DMF 240852010

ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO LTDInactiveESTRADIOL

DMF 241922010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2024	SUPPL -19	View Letter (PDF)
Aug 2, 2023	SUPPL -18	View Letter (PDF)
Dec 1, 2021	SUPPL -17	View Letter (PDF)
Mar 27, 2014	SUPPL -10	View Letter (PDF)
Jan 29, 2008	SUPPL -7	View Letter (PDF)
Jul 30, 2007	SUPPL -5	View Letter (PDF)
Sep 15, 2004	SUPPL -1	View Letter (PDF)
Mar 2, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.06%

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Feb 9, 2004

No patent or exclusivity listings for this strength.

#002 — 0.06% (1.25GM/ACTIVATION)

RLDAB

0 patents0 exclusivities▾

GEL, METERED;TRANSDERMAL | Approved: Feb 9, 2004