Viewing data from:

MINIPRESS

NDA

PRAZOSIN HYDROCHLORIDE | N017442 | PFIZER LABORATORIES DIV PFIZER INC

3 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Appco Pharma LLC FDA-2026-P-5122 Appco Pharma LLC filed this suitability petition pursuant to section 505(j)(2)(C) of the FDC Act and 21 C.F.R. § 314.93, requesting FDA approval to submit an ANDA for Prazosin Hydrochloride Capsules in 3 mg and 4 mg strengths, which differ from the Reference Listed Drug MINIPRESS (Prazosin Hydrochlo	Suitability	2026-05-08	Open	Appco Pharma LLC

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 Minipress (2023)

Total Spending

$14K

Total Claims

Beneficiaries

Avg Cost/Unit

$2.72

Spending Trend

$15K(2019)→$17K(2020)→$22K(2021)→$15K(2022)→$14K(2023)

YoY Change:+4.4%

5yr CAGR:+0.8%

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

API Supply Chain7 active DMFs10 inactive

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

SA AJINOMOTO OMNICHEM NVPRAZOSIN HYDROCHLORIDE

DMF 71611987

BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPAPRAZOSIN HYDROCHLORIDE BULK SUBSTANCE

DMF 153212001

NOVITIUM PHARMA LLCPRAZOSIN HYDROCHLORIDE USP

DMF 316282017

MSN ORGANICS PRIVATE LTDPRAZOSIN HYDROCHLORIDE USP (POLYHYDRATE)

DMF 330142018

GRANULES INDIA LTDPRAZOSIN HYDROCHLORIDE USP

DMF 352102020

AURORE LIFE SCIENCES PRIVATE LTDPRAZOSIN HYDROCHLORIDE USP

DMF 354862020

SYNTHOKEM LABS PRIVATE LTDPRAZOSIN HYDROCHLORIDE

DMF 392202024

HEUMANN PCS GMBHInactivePRAZOSIN HYDROCHLORIDE

DMF 61831986

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANAInactivePRAZOSIN HYDROCHLORIDE

DMF 63541986

EURAND AMERICA INCInactivePRAZOSIN HYDROCHLORIDE CONTROLLED RELEASE TABLETS

DMF 70321987

SUMITOMO CHEMICAL CO LTDInactivePRAZOSIN HYDROCHLORIDE

DMF 71541987

ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIVInactivePRAZOSIN HYDROCHLORIDE USP&PRAZOSIN HYDROCHLORIDE,POLYHYDRATE

DMF 72031987

SUMIKA FINE CHEMICALS CO LTDInactivePRAZOSIN HYDROCHLORIDE (POLYHYDRATE)

DMF 77221988

PROSINTEX INDUSTRIE CHIMIQUE ITALIANE SRLInactivePRAZOSIN HYDROCHLORIDE

DMF 77951988

FERMION OYInactivePRAZOSIN HYDROCHLORIDE

DMF 91881991

CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTDInactivePRAZOSIN HYDROCHLORIDE

DMF 106781993

STANDARD CHEM AND PHARM CO LTDInactivePRAZOSIN HYDROCHLORIDE

DMF 182342005

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Mar 2, 2015	SUPPL -43	View Letter (PDF)
Nov 7, 2013	SUPPL -41	View Letter (PDF)
Jul 15, 2009	SUPPL -35	View Letter (PDF)
Apr 9, 2009	SUPPL -33	View Letter (PDF)
Jun 12, 2001	SUPPL -29	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 5MG BASE

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — EQ 2MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982