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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Intrarosa (2023)

Total Spending

$3.8M

Total Claims

9,901

Beneficiaries

3,100

Avg Cost/Unit

$9.23

Spending Trend

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

YoY Change:+6.5%

5yr CAGR:+6.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs

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

PRODUCTOS QUIMICOS NATURALES SA DE CV PROQUINAPRASTERONE (DEHYDROEPIANDROSTERONE)

DMF 242162010

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

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)

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