Viewing data from:

INTRAROSA

NDA

PRASTERONE | N208470 | MILLICENT PHARMA LTD

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

Today

8268806

Mar. 19, 2031

8629129

Aug. 7, 2028

8957054

Jan. 8, 2030

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

18 trials from ClinicalTrials.gov, 13 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa NCT00310791	Phase 2/3	Completed	Boston Children's Hospital	80	2004-04 → 2010-12
Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma NCT00006219	Phase 2	Completed	Mayo Clinic	—	2000-08 → 2006-12
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy NCT01358760	Phase 3	Completed	EndoCeutics Inc.	450	2011-06 → 2012-05
Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women NCT01452373	Phase 3	Completed	EndoCeutics Inc.	238	2011-10 → 2013-05
GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids NCT00082511	Phase 3	Completed	Genelabs Technologies	114	2003-07 → 2005-08
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study NCT01256684	Phase 3	Completed	EndoCeutics Inc.	255	2010-12 → 2011-11
Topical DHEA Against Vaginal Atrophy NCT01846442	Phase 3	Completed	EndoCeutics Inc.	218	2007-06 → 2008-10
Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause NCT02013544	Phase 3	Completed	EndoCeutics Inc.	558	2014-02 → 2015-02
Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia NCT03568604	Phase 4	Completed	San Diego Sexual Medicine	18	2018-08-07 → 2020-01-28
Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms NCT01376349	Phase 3	Completed	Alliance for Clinical Trials in Oncology	464	2011-07 → 2017-11

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

$11.00

per ea

Lowest NADAC/Unit

$11.00

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
72495040128INTRAROSA 6.5 MG VAG INSERT	$11.00	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$199.46

Highest Price

$266.09

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
72495-0401-28INTRAROSA 6.5MG INSERT,VAG	$266.09	FSS	Millicent U.S., Inc.	04/30/2030
72495-0401-28INTRAROSA 6.5MG INSERT,VAG	$199.46	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 Intrarosa (2024)

Total Spending

$4.3M

Total Claims

11,112

Beneficiaries

3,611

Avg Cost/Unit

$9.27

Spending Trend

$3.6M(2019)→$3.7M(2020)→$3.8M(2021)→$3.8M(2022)→$3.8M(2023)→$4.3M(2024)

YoY Change:+0.4%

5yr CAGR:+5.4%

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

API Supply Chain5 active DMFs1 inactive

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

JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP LTDPRASTERONE ACETATE

DMF 244382010

FIS FABBRICA ITALIANA SINTETICI SPAPRASTERONE ACETATE

DMF 273402013

ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO LTDPRASTERONE ACETATE

DMF 282542014

PFIZER INCPRASTERONE ACETATE

DMF 287292014

JIANGSU JIAERKE PHARMACEUTICALS GROUP CORP LTDPRASTERONE

DMF 323612017

PRODUCTOS QUIMICOS NATURALES SA DE CV PROQUINAInactivePRASTERONE (DEHYDROEPIANDROSTERONE)

DMF 242162010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 17, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 6.5MG

RLD

3 patents0 exclusivities▴

INSERT;VAGINAL | Approved: Nov 16, 2016

Patents (3) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8268806	Mar 19, 2031	—	—	Yes	—	—
8629129	Aug 7, 2028	—	—	Yes	—	—
8957054	Jan 8, 2030	—	—	—		—