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NDA

PROGESTERONE | N201110 | FERRING PHARMACEUTICALS INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

Today

8580293

Jan. 21, 2030

10537584

Feb. 3, 2029

10548904

Feb. 3, 2029

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Apr 30, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.78GM

RLD

3 patents0 exclusivities▴

SYSTEM;VAGINAL | Approved: Apr 29, 2020

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8580293	Jan 21, 2030	—	—	—		—
10537584	Feb 3, 2029	—	—	Yes	—	—
10548904	Feb 3, 2029	—	—	—		—