Viewing data from:

UROXATRAL

NDA

ALFUZOSIN HYDROCHLORIDE | N021287 | ADVANZ PHARMA (US) CORP

1 strength0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

41 trials from ClinicalTrials.gov, 30 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH NCT00290030	Phase 3	Completed	Sanofi	800	2001-05 → 2004-10
Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort NCT00467467	Phase 3	Completed	University of Minnesota	60	2006-06 → 2007-10
An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms NCT00893113	Phase 3	Completed	Chesapeake Urology Research Associates	74	2009-06 → 2012-10
Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy NCT00542165	Phase 4	Completed	Sanofi	166	2004-03 → 2004-12
Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology NCT00629720	Phase 3	Completed	Sanofi	29	2006-07 → 2007-02
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Alfuzosin ER Tablets Under Fed Conditions NCT01418599	Phase 1	Completed	Torrent Pharmaceuticals Limited	—	—
Alfuzosin for Treating Acute Urinary Retention NCT00336921	Phase 2	Completed	Sanofi	156	2006-02
Study to Assess the Influence of Three Different α-antagonists and Placebo on the Extent of Weekly Phenylephrine-induced Mydriasis at Three Different Concentrations of Phenylephrine in Healthy Male Volunteers NCT02266537	Phase 1	Completed	Boehringer Ingelheim	97	2005-11
Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study NCT00575913	Phase 4	Completed	Sanofi	118	2003-09 → 2005-03
SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin NCT00486785	Phase 4	Completed	Sanofi	431	2006-04 → 2008-03

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$2090.78

Highest Price

$2741.74

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59212-0200-10UROXATRAL 10MG TAB,SA	$2741.74	FSS	Amdipharm Limited	09/28/2026
59212-0200-10UROXATRAL 10MG TAB,SA	$2090.78	Big4	Amdipharm Limited	09/28/2026

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

Medicare Part D Spending

CMS annual spending data for Uroxatral (2024)

Total Spending

$1.7M

Total Claims

1,045

Beneficiaries

231

Avg Cost/Unit

$25.58

Spending Trend

$2.3M(2019)→$2.0M(2020)→$1.9M(2021)→$1.9M(2022)→$1.9M(2023)→$1.7M(2024)

YoY Change:-3.5%

5yr CAGR:+4.3%

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

API Supply Chain9 active DMFs10 inactive

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

ALIVUS LIFE SCIENCES LTDALFUZOSIN HYDROCHLORIDE USP

DMF 196752006

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

DMF 203072007

WOCKHARDT LTDALFUZOSIN HYDROCHLORIDE

DMF 204392007

HETERO DRUGS LTDALFUZOSIN HYDROCHLORIDE

DMF 205772007

APOTEX INCALFUZOSIN HYDROCHLORIDE USP

DMF 205952007

MSN LABORATORIES PRIVATE LTDALFUZOSIN HYDROCHLORIDE USP [ROUTE CODE-"AE"]

DMF 208672007

SANOFI CHIMIEALFUZOSIN HYDROCHLORIDE

DMF 208882007

UNICHEM LABORATORIES LTDALFUZOSIN HYDROCHLORIDE USP

DMF 226382009

TORRENT PHARMACEUTICALS LTDALFUZOSIN HYDROCHLORIDE USP

DMF 236032010

SANOFI SYNTHELABO INCInactiveALFUZOSIN HYDROCHLORIDE DRUG SUBSTANCE

DMF 119761996

FINORGAInactiveALFUZOSIN HYDROCHLORIDE

DMF 125461997

EXCELLA GMBH AND CO KGInactiveALFUZOSIN HYDROCHLORIDE

DMF 176242004

CIPLA LTDInactiveALFUZOSIN HYDROCHLORIDE

DMF 191802006

FARMAK ASInactiveALFUZOSIN HYDROCHLORIDE

DMF 194762006

STANDARD CHEM AND PHARM CO LTDInactiveALFUZOSIN HYDROCHLORIDE

DMF 197862006

DR REDDYS LABORATORIES LTDInactiveALFUZOSIN HYDROCHLORIDE

DMF 199612006

SHANDONG NEW TIME PHARMACEUTICAL CO LTDInactiveALFUZOSIN HYDROCHLORIDE

DMF 203502007

CADILA HEALTHCARE LTDInactiveALFUZOSIN HYDROCHLORIDE

DMF 203792007

LUNDBECK PHARMACEUTICALS ITALY SPAInactiveALFUZOSIN HYDROCHLORIDE

DMF 205402007

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
May 28, 2020	SUPPL -24	View Letter (PDF)
May 16, 2018	SUPPL -21	View Letter (PDF)
Aug 6, 2014	SUPPL -18	View Letter (PDF)
May 31, 2013	SUPPL -17	View Letter (PDF)
Dec 21, 2010	SUPPL -16	View Letter (PDF)
Apr 13, 2010	SUPPL -14	View Letter (PDF)
May 27, 2009	SUPPL -13	View Letter (PDF)
Sep 23, 2008	SUPPL -11	View Letter (PDF)
May 9, 2008	SUPPL -9	View Letter (PDF)
Apr 9, 2007	SUPPL -8	View Letter (PDF)
Nov 22, 2006	SUPPL -7	View Letter (PDF)
Mar 23, 2006	SUPPL -5	View Letter (PDF)
Jul 28, 2003	SUPPL -1	View Letter (PDF)
Jun 22, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 12, 2003

No patent or exclusivity listings for this strength.