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NDA

TERAZOSIN HYDROCHLORIDE | N218139 | NOVITIUM PHARMA LLC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

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Today

11224572

Feb. 1, 2041

12427108

Feb. 1, 2041

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 Chain6 active DMFs11 inactive

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

CU CHEMIE UETIKON GMBHTERAZOSIN HYDROCHLORIDE ANHYDROUS

DMF 100351993

TAPI NL BVTERAZOSIN HYDROCHLORIDE

DMF 113001995

SIGNA SA DE CVTERAZOSIN HYDROCHLORIDE DIHYDRATE USP

DMF 182682005

APITORIA PHARMA PRIVATE LTDTERAZOSIN HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 201132006

JUBILANT PHARMOVA LTDTERAZOSIN HYDROCHLORIDE

DMF 210662007

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTERAZOSIN HYDROCHLORIDE

DMF 375772022

SUMITOMO CHEMICAL CO LTDInactiveTERAZOSIN HYDROCHLORIDE

DMF 91571991

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANAInactiveTERAZOSIN HYDROCHLORIDE

DMF 100541993

ORION CORP FERMIONInactiveTERAZOSIN HYDROCHLORIDE DIHYDRATE

DMF 118821996

BASF PHARMACHEMIKALIEN GMBH CO KGInactiveTERAZOSIN HYDROCHLORIDE

DMF 122441996

CILAG AGInactiveTERAZOSIN HYDROCHLORIDE MONOHYDRATE

DMF 126491997

PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTDInactiveTERAZOSIN HYDROCHLORIDE

DMF 145321999

CADILA HEALTHCARE LTDInactiveTERAZOSIN HYDROCHLORIDE ANHYDROUS

DMF 176052004

SECOND PHARMA CO LTDInactiveTERAZOSIN HYDROCHLORIDE

DMF 193622006

ARCHIMICA SRLInactiveTERAZOSIN HYDROCHLORIDE

DMF 194802006

STANDARD CHEM AND PHARM CO LTDInactiveTERAZOSIN HYDROCHLORIDE

DMF 200252006

CTX LIFE SCIENCES PVT LTDInactiveTERAZOSIN HYDROCHLORIDE DIHYDRATE USP

DMF 258292012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 30, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1MG BASE/ML

RLD

2 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jul 29, 2024

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11224572	Feb 1, 2041	—	—	Yes		—
12427108	Feb 1, 2041	—	—	Yes		—