Viewing data from:

CRINONE

NDA

PROGESTERONE | N020701 | ABBVIE INC

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition Amendment from DDReg Pharma Inc. FDA-2024-P-0427 DDReg Pharma Inc. filed this amendment to suitability petition FDA-2024-P-0427 seeking approval to submit an ANDA for a progesterone pessary formulation at 400 mg strength in vaginal pessary dosage form, with Crinone 8% gel (90 mg vaginal gel, NDA N020701) as the reference listed drug, and requestin	Suitability	2024-02-16	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Crinone (2023)

Total Spending

$71K

Total Claims

123

Beneficiaries

Avg Cost/Unit

$22.42

Spending Trend

$61K(2019)→$75K(2020)→$80K(2021)→$65K(2022)→$71K(2023)

YoY Change:-2.6%

5yr CAGR:-4.2%

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

API Supply Chain14 active DMFs8 inactive

11 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

PRODUCTOS QUIMICOS NATURALES SA DE CVPROGESTERONE

DMF 54161984

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

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

SIGNA SA DE CVInactivePROGESTERONE USP

DMF 266402012

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Dec 14, 2011	SUPPL -21	View Letter (PDF)
Dec 14, 2011	SUPPL -20	View Letter (PDF)
Dec 14, 2011	SUPPL -23	View Letter (PDF)
Mar 29, 2005	SUPPL -14	View Letter (PDF)
Nov 26, 2003	SUPPL -12	View Letter (PDF)
Sep 29, 2003	SUPPL -11	View Letter (PDF)
Apr 23, 2001	SUPPL -9	View Letter (PDF)
Apr 11, 2001	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 4%

RLD

0 patents0 exclusivities▴

GEL;VAGINAL | Approved: Jul 31, 1997

No patent or exclusivity listings for this strength.

#002 — 8%

RLD

0 patents0 exclusivities▾

GEL;VAGINAL | Approved: Jul 31, 1997