Viewing data from:

CARDURA XL

NDA

DOXAZOSIN MESYLATE | N021269 | VIATRIS SPECIALTY LLC

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
Lawrence D. Bernhardt & Arnold Liebman (Milberg, Weiss, Bershad, Hynes, and L... FDA-2001-P-0524 · 9 docket documents Lawrence D. Bernhardt and Arnold Liebman, represented by Milberg, Weiss, Bershad, Hynes, and Lerach LLP, filed this citizen petition seeking FDA action regarding Cardura (doxazosin mesylate) manufactured by Pfizer. The petitioners, representing a civil class action of Cardura users treated for hyper	Other	2012-06-18	Open	—

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

Clinical Trials

48 trials from ClinicalTrials.gov — 1 recruiting, 38 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Alpha-1 Blockade for Alcohol Use Disorder (AUD)NCT04135846	Phase 2	Recruiting	Brown University	184	2019-12-19 → 2026-08-31
Ureteral Stent Study NCT03043612	N/A	Completed	Cook Group Incorporated	56	2015-06-10 → 2017-06-30
Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy NCT00295555	Phase 4	Completed	Yokohama City University Medical Center	98	2004-01 → 2007-04
Pharmacological Interaction Between Doxazosin and Methylenedioxymethamphetamine (MDMA)NCT01386177	Phase 1	Completed	University Hospital, Basel, Switzerland	16	2011-07 → 2012-01
Combination Treatment With Doxazosin Plus TolterodineSR 2 mg Versus 4mg in Men With an Overactive Bladder (OAB) and Benign Prostatic Hyperplasia (BPH)NCT00922506	Phase 4	Completed	Samsung Medical Center	83	2009-05 → 2014-06
Effect of Beta-blockers on Structural Remodeling and Gene Expression in the Failing Human Heart NCT01798992	Phase 4	Completed	University of Colorado, Denver	56	2000-09 → 2009-03
DOX as a Potential Treatment for Methamphetamine Dependence NCT02785393	Phase 1	Completed	Baylor College of Medicine	11	2011-03 → 2016-03
Phenoxybenzamine Versus Doxazosin in PCC Patients NCT01379898	Phase 4	Completed	University Medical Center Groningen	134	2011-12 → 2018-01
Complementary Combination Therapy for Cocaine Dependence NCT02538744	Phase 1	Completed	Baylor College of Medicine	45	2015-08 → 2018-08-21
Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension NCT00130156	Phase 4	Completed	Eisai Inc.	93	2005-10 → 2009-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$7.00

per ea

Lowest NADAC/Unit

$7.00

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
58151007893CARDURA XL 4 MG TABLET	$7.00	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$108.36

Highest Price

$108.49

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
58151-0078-93CARDURA XL 4MG TAB	$108.36	FSS	Mylan Specialty L.P.	01/14/2027
58151-0078-93CARDURA XL 4MG TAB	$108.36	Big4	Mylan Specialty L.P.	01/14/2027
58151-0079-93CARDURA XL 8MG TAB	$108.49	FSS	Mylan Specialty L.P.	01/14/2027
58151-0079-93CARDURA XL 8MG TAB	$108.49	Big4	Mylan Specialty L.P.	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Cardura XL (2024)

Total Spending

$821K

Total Claims

2,157

Beneficiaries

698

Avg Cost/Unit

$6.71

Spending Trend

$674K(2019)→$780K(2020)→$820K(2021)→$703K(2022)→$804K(2023)→$821K(2024)

YoY Change:+0.6%

5yr CAGR:+4.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs8 inactive

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

EXCELLA GMBH AND CO KGDOXAZOSIN MESYLATE

DMF 126341997

DR REDDYS LABORATORIES LTDDOXAZOSIN MESYLATE USP

DMF 127501997

APOTEX PHARMACHEM INDIA PVT LTDDOXAZOSIN MESYLATE USP

DMF 130391998

APITORIA PHARMA PRIVATE LTDDOXAZOSIN MESYLATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 199592006

COHANCE LIFESCIENCES LTDDOXAZOSIN MESYLATE USP

DMF 229412009

UNICHEM LABORATORIES LTDDOXAZOSIN MESYLATE USP

DMF 323752018

CIPLA LTDInactiveDOXAZOSIN MESYLATE

DMF 127841997

BASF PHARMACHEMIKALIEN GMBH CO KGInactiveDOXAZOSIN MESYLATE

DMF 138071998

CILAG AGInactiveDOXAZOSIN MESYLATE

DMF 141731999

PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTDInactiveDOXAZOSIN MESYLATE

DMF 142811999

MEDICHEM SAInactiveDOXAZOSIN MESYLATE

DMF 143661999

WOCKHARDT LTDInactiveDOXAZOSIN MESYLATE

DMF 152402001

CHONGQING BIOCARE PHARMACEUTICAL CO LTDInactiveDOXAZOSIN MESYLATE USP

DMF 206642007

STANDARD CHEM AND PHARM CO LTDInactiveDOXAZOSIN MESYLATE

DMF 207702007

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jun 24, 2021	SUPPL -21	View Letter (PDF)
Mar 3, 2017	SUPPL -18	View Letter (PDF)
Jun 10, 2015	SUPPL -17	View Letter (PDF)
Jul 12, 2011	SUPPL -12	View Letter (PDF)
Mar 22, 2010	SUPPL -11	View Letter (PDF)
Apr 5, 2006	SUPPL -1	View Letter (PDF)
Feb 23, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 4MG BASE

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 22, 2005

No patent or exclusivity listings for this strength.

#002 — EQ 8MG BASE

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 22, 2005