Viewing data from:

FEMRING

NDA

ESTRADIOL ACETATE | N021367 | MILLICENT MANUFACTURING PR 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

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

$928.58

per ea

Lowest NADAC/Unit

$867.52

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
72495020210FEMRING 0.10 MG/DAY VAG RING	$928.58	EA	Brand	—	2026-06-17
72495020105FEMRING 0.05 MG/DAY VAG RING	$867.52	EA	Brand	—	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

$558.00

Highest Price

$797.91

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
72495-0201-05FEMRING 0.05MG/24HR RING,VAG	$748.76	FSS	Millicent U.S., Inc.	04/30/2030
72495-0201-05FEMRING 0.05MG/24HR RING,VAG	$558.00	Big4	Millicent U.S., Inc.	04/30/2030
72495-0202-10FEMRING 0.1MG/24HR RING,VAG	$797.91	FSS	Millicent U.S., Inc.	04/30/2030
72495-0202-10FEMRING 0.1MG/24HR RING,VAG	$596.48	Big4	Millicent U.S., Inc.	04/30/2030

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

Medicare Part D Spending

CMS annual spending data for Femring (2024)

Total Spending

$7.0M

Total Claims

9,145

Beneficiaries

3,074

Avg Cost/Unit

$753.54

Spending Trend

$3.5M(2019)→$5.1M(2020)→$5.6M(2021)→$6.0M(2022)→$6.5M(2023)→$7.0M(2024)

YoY Change:+2.4%

5yr CAGR:+9.0%

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2024	SUPPL -21	View Letter (PDF)
Aug 22, 2023	SUPPL -20	View Letter (PDF)
Nov 7, 2017	SUPPL -16	View Letter (PDF)
Aug 15, 2017	SUPPL -14	View Letter (PDF)
Aug 15, 2017	SUPPL -15	View Letter (PDF)
Jun 2, 2014	SUPPL -13	View Letter (PDF)
May 27, 2009	SUPPL -9	View Letter (PDF)
Feb 23, 2007	SUPPL -7	View Letter (PDF)
Aug 19, 2005	SUPPL -5	View Letter (PDF)
Mar 14, 2005	SUPPL -2	View Letter (PDF)
Mar 26, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.05MG BASE/24HR

RLD

0 patents0 exclusivities▴

INSERT, EXTENDED RELEASE;VAGINAL | Approved: Mar 20, 2003

No patent or exclusivity listings for this strength.

#002 — EQ 0.1MG BASE/24HR

RLD

0 patents0 exclusivities▾

INSERT, EXTENDED RELEASE;VAGINAL | Approved: Mar 20, 2003