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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

385 trials from ClinicalTrials.gov — 2 recruiting, 4 active, 285 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
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
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
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
Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome NCT03401047	Early Phase 1	Recruiting	University of Virginia	37	2017-11-30 → 2025-12-01
A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies NCT03557619	Phase 1	Recruiting	AbbVie	12	2019-07-30 → 2026-03-21
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions NCT01340625	Phase 1	Completed	Teva Pharmaceuticals USA	36	2006-12 → 2007-01
Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy NCT02467673	Phase 2	Completed	University Potiguar	185	2012-01 → 2012-07
A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)NCT03608241	Phase 1	Completed	Pfizer	12	2018-09-21 → 2018-11-23
Study of Physiological and High Dose Estradiol in the Treatment of Hormone Receptor Positive Metastatic Breast Cancer NCT00324259	Phase 2	Completed	Washington University School of Medicine	66	2004-08 → 2014-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$35.84

per ml

Lowest NADAC/Unit

$25.55

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
42023011101DELESTROGEN 100 MG/5 ML VIAL	$35.84	ML	Brand	$20.90	2026-06-17
42023011001DELESTROGEN 50 MG/5 ML VIAL	$25.55	ML	Brand	$18.25	2026-06-17

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