Viewing data from:

ENDOMETRIN

NDA

PROGESTERONE | N022057 | FERRING PHARMACEUTICALS INC

1 strength0 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

236 trials from ClinicalTrials.gov — 4 recruiting, 1 active, 145 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
Verify the Safety and Effectiveness of the Cerclage Pessary in Prevention and Treatment of High-risk Preterm Pregnancy NCT03637062	N/A	Not Yet Recruiting	QH Medical Technology Ltd.	300	2024-12-01 → 2026-12-01
Hyperandrogenemia and Altered Day-night LH Pulse Patterns NCT03068910	Early Phase 1	Recruiting	University of Virginia	32	2016-07-21 → 2025-12-01
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism NCT00929006	Early Phase 1	Recruiting	University of Virginia	36	2008-06 → 2025-12-01
Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC NCT03463252	Phase 2/3	Recruiting	West China Second University Hospital	224	2018-04-01 → 2030-12-30
Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)NCT01225835	Phase 4	Completed	Ferring Pharmaceuticals	124	2010-10 → 2013-06
Progesterone for Perimenopausal Night Sweats NCT01464697	Phase 3	Completed	University of British Columbia	249	2011-10 → 2018-06-01
Neurophysiology of Postpartum Depression in an Experimental Model of Pregnancy and Parturition NCT01762943	N/A	Completed	University of North Carolina, Chapel Hill	36	2013-08 → 2016-10-13
Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS NCT01909141	Early Phase 1	Completed	Cairo University	100	2013-08 → 2014-04
Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures NCT02048891	Phase 4	Completed	Rambam Health Care Campus	3	2014-10 → 2015-04

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$15.15

per ea

Lowest NADAC/Unit

$15.15

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
55566650003ENDOMETRIN 100 MG VAG INSERT	$15.15	EA	Brand	$12.53	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$198.27

Highest Price

$198.27

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
55566-6500-03ENDOMETRIN VAGINAL INSERT, 100MG	$198.27	FSS	Ferring Pharmaceuticals, Inc.	12/31/2026
55566-6500-03ENDOMETRIN VAGINAL INSERT, 100MG	$198.27	Big4	Ferring Pharmaceuticals, Inc.	12/31/2026

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

Medicare Part D Spending

CMS annual spending data for Endometrin (2024)

Total Spending

$9K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$13.13

Spending Trend

$11K(2019)→$10K(2020)→$21K(2021)→$13K(2022)→$8K(2023)→$9K(2024)

YoY Change:-11.5%

5yr CAGR:+0.1%

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

API Supply Chain13 active DMFs10 inactive

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

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCPROGESTERONE MICRONIZED AND CRYSTALS

DMF 14181969

ASPEN OSS BVPROGESTERONE

DMF 38231980

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTDPROGESTERONE USP (BULK)

DMF 197922006

FIS FABBRICA ITALIANA SINTETICI SPAPROGESTERONE

DMF 220962008

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDPROGESTERONE

DMF 276682013

JIANGXI HONGYUAN PHARMACEUTICAL CO LTDPROGESTERONE

DMF 286552014

JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP LTDPROGESTERONE

DMF 307932016

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCPROGESTERONE USP

DMF 320992017

SYMBIOTEC PHARMALAB PRIVATE LTDPROGESTERONE USP

DMF 327092018

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDPROGESTERONE (PROCESS II)

DMF 330032018

INDUSTRIALE CHIMICA SRLPROGESTERONE USP

DMF 355412021

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTDPROGESTERONE API PROCESS II

DMF 357902021

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDPROGESTERONE

DMF 417292025

CINBERG B L MDInactivePROGESTERONE

DMF 261946

ORGANON SUB AKZONA INCInactivePROGESTERONE

DMF 17631971

ANTIBIOTICOS SPAInactivePROGESTERONE 16a, 17a- ACETOPHENIDE

DMF 26871976

SIGMA F AND D DIV LTDInactivePROGESTERONE

DMF 32561978

PRODUCTOS QUIMICOS NATURALES SA DE CVInactivePROGESTERONE

DMF 54161984

WATSON LABORATORIES INCInactivePROGESTERONE VAGINAL SUPPOSITORY 100 MG. AND 200 MG.

DMF 101071993

CHANGZHOU JIAERKE PHARMACEUTICALS GROUP CORP LTDInactivePROGESTERONE

DMF 202572007

CATALENT PHARMA SOLUTIONS LLCInactivePROGESTERONE SOFT GELATIN CAPSULES 100 MG AND 200 MG

DMF 238272010

ZHEJIANG XIANJU XIANMING PHARMACEUTICAL CO LTDInactivePROGESTERONE, USP

DMF 264342012

SIGNA SA DE CVInactivePROGESTERONE USP

DMF 266402012

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 8, 2009	SUPPL -2	View Letter (PDF)
Feb 27, 2008	SUPPL -1	View Letter (PDF)
Jul 5, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

RLDAB

0 patents0 exclusivities▴

INSERT;VAGINAL | Approved: Jun 21, 2007

No patent or exclusivity listings for this strength.