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DELESTROGEN

NDA

ESTRADIOL VALERATE | N009402 | PH HEALTH LTD

3 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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$35.74

per ml

Lowest NADAC/Unit

$25.50

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
42023011101DELESTROGEN 100 MG/5 ML VIAL	$35.74	ML	Brand	$21.54	2026-08-19
42023011001DELESTROGEN 50 MG/5 ML VIAL	$25.50	ML	Brand	$18.26	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$74.56

Highest Price

$95.89

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42023-0110-01DELESTROGEN 10MG/ML INJ (IN OIL)	$74.56	Big4	Endo USA, Inc.	09/30/2026
42023-0110-01DELESTROGEN 10MG/ML INJ (IN OIL)	$74.56	FSS	Endo USA, Inc.	09/30/2026
42023-0111-01DELESTROGEN 20MG/ML INJ (IN OIL)	$95.89	Big4	Endo USA, Inc.	09/30/2026
42023-0111-01DELESTROGEN 20MG/ML INJ (IN OIL)	$95.89	FSS	Endo USA, Inc.	09/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Delestrogen (2024)

Total Spending

$77K

Total Claims

475

Beneficiaries

209

Avg Cost/Unit

$30.53

Spending Trend

$369K(2019)→$272K(2020)→$255K(2021)→$171K(2022)→$132K(2023)→$77K(2024)

YoY Change:-9.0%

5yr CAGR:-4.1%

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

Medicare Part B Spending

CMS physician-administered drug spending for Delestrogen (2024)

Total Spending

$36K

Total Claims

3,086

Beneficiaries

524

ASP Price

$8.43

Spending Trend

$92K(2019)→$54K(2020)→$62K(2021)→$50K(2022)→$50K(2023)→$36K(2024)

YoY Change:-19.7%

5yr CAGR:-0.3%

HCPCS: J1380 — Injection, estradiol valerate, up to 10 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain5 active DMFs2 inactive

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

BAYER AGESTRADIOL VALERATE

DMF 33791978

ASPEN OSS BVESTRADIOL VALERATE

DMF 122681996

VALDEPHARMESTRADIOL VALERATE

DMF 239482010

LUPIN LTDESTRADIOL VALERATE USP

DMF 258542012

STEROID SPAESTRADIOL VALERATE

DMF 395942024

ROUSSELL UCLAFInactiveESTRADIOL VALERATE

DMF 30721977

GEDEON RICHTER PLCInactiveESTRADIOL VALERATE

DMF 245532011

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2024	SUPPL -63	View Letter (PDF)
Feb 17, 2022	SUPPL -60	View Letter (PDF)
Nov 6, 2017	SUPPL -52	View Letter (PDF)
Oct 15, 2007	SUPPL -41	View Letter (PDF)
Jul 28, 2004	SUPPL -40	View Letter (PDF)
Dec 16, 2003	SUPPL -37	View Letter (PDF)
Dec 16, 2003	SUPPL -39	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — 10MG/ML

RLDAO

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — 20MG/ML

RLDAO

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982