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FLOMAX

NDA

TAMSULOSIN HYDROCHLORIDE | N020579 | SANOFI AVENTIS US LLC

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Amendment to Suitability Petition from Rising Pharma Holdings, Inc. FDA-2026-P-3630 · 6 docket documents Rising Pharma Holdings, Inc. filed an amendment to suitability petition FDA-2026-P-3630 on April 28, 2026, in response to an FDA information request dated April 20, 2026, providing the reference listed drug product labeling for FLOMAX and proposed labeling for Tamsulosin Hydrochloride Capsules, USP	Suitability	2026-04-28	Open	Rising Pharma Holdings, Inc.

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

Clinical Trials

155 trials from ClinicalTrials.gov — 6 recruiting, 1 active, 106 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer NCT04147806	Phase 1	Active	Albert Einstein College of Medicine	31	2016-08-01 → 2026-07
Iris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients NCT07743034	Phase 4	Not Yet Recruiting	Mohsen Pourazizi	40	2026-08 → 2027-04
Pupil Size and Choroidal Thickness Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients NCT07743060	Phase 4	Not Yet Recruiting	Mohsen Pourazizi	40	2026-08 → 2027-04
Comparison of Alpha Blockers (Terazosin and Tamsulosin) in Reducing Ureteral Stent Related Symptoms NCT06966804	Phase 3	Recruiting	Penang Hospital, Malaysia	150	2025-06-01 → 2027-07-31
Post-operative Urinary Retention (POUR) Following Thoracic Surgery NCT03609580	Phase 1/2	Recruiting	Hackensack Meridian Health	127	2018-05-07 → 2027-03-30
Uroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery NCT07174349	Phase 4	Recruiting	Mayo Clinic	20	2026-10-01 → 2028-12-31
Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH NCT07722884	N/A	Recruiting	Ain Shams University	90	2026-07-01 → 2027-01-01
Clinical Study to Determine Bioequivalence of Oral Tamsulosin Products as 0.4 mg Prolonged-release Tablets in Male Subjects Under Fasted Conditions NCT07698275	N/A	Completed	ADIUM	34	2026-01-12 → 2026-03-19
Clinical Study to Determine Bioequivalence of Oral Tamsulosin Products as 0.4 mg Prolonged-release Tablets in Male Subjects Under Fed Conditions NCT07698288	N/A	Completed	ADIUM	66	2026-02-12 → 2026-04-16
Effect of Different Dosing Regimens of Tadalafil or Tamsulosin Combined With 5α-Reductase Inhibitors on Urinary and Sexual Outcomes in Benign Prostatic Hyperplasia NCT07715448	Phase 4	Completed	Beni-Suef University	240	— → 2026-01-01

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Medicare Part D Spending

CMS annual spending data for Flomax (2024)

Total Spending

$2.3M

Total Claims

3,092

Beneficiaries

991

Avg Cost/Unit

$8.79

Spending Trend

$1.2M(2019)→$3.5M(2020)→$3.5M(2021)→$2.0M(2022)→$2.4M(2023)→$2.3M(2024)

YoY Change:-7.8%

5yr CAGR:+3.6%

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

API Supply Chain19 active DMFs17 inactive

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

LEK PHARMACEUTICALS DDTAMSULOSIN HYDROCHLORIDE

DMF 173182004

ZYDUS LIFESCIENCES LTDTAMSULOSIN HYDROCHLORIDE USP

DMF 176882004

SCINOPHARM TAIWAN LTDTAMSULOSIN HYDROCHLORIDE USP

DMF 187172005

DIVIS LABORATORIES LTDTAMSULOSIN HYDROCHLORIDE

DMF 189712005

COHANCE LIFESCIENCES LTDTAMSULOSIN HYDROCHLORIDE

DMF 196472006

SYNTHON BVTAMSULOSIN HYDROCHLORIDE

DMF 200822006

WOCKHARDT LTDTAMSULOSIN HYDROCHLORIDE

DMF 200952006

QUIMICA SINTETICA SATAMSULOSIN HYDROCHLORIDE

DMF 210412007

SUN PHARMACEUTICAL INDUSTRIES LTDTAMSULOSIN HYDROCHLORIDE USP

DMF 219002008

GENTHON BVTAMSULOSIN HYDROCHLORIDE

DMF 223892009

MEDICHEM SATAMSULOSIN HYDROCHLORIDE (MED-201750/E)

DMF 231452009

ALP PHARM BEIJING CO LTDTAMSULOSIN HYDROCHLORIDE

DMF 237412010

UNICHEM LABORATORIES LTDTAMSULOSIN HYDROCHLORIDE USP

DMF 243742010

COHANCE LIFESCIENCES LTDTAMSULOSIN HYDROCHLORIDE USP

DMF 286482014

MACLEODS PHARMACEUTICALS LTDTAMSULOSIN HYDROCHLORIDE MODIFIED RELEASE PELLETS 0.4 MG/ 275MG

DMF 304502016

MACLEODS PHARMACEUTICALS LTDTAMSULOSIN HYDROCHLORIDE USP

DMF 358002021

SWATI SPENTOSE PRIVATE LTDTAMSULOSIN HYDROCHLORIDE USP

DMF 369342022

VASUDHA PHARMA CHEM LTDTAMSULOSIN HYDROCHLORIDE USP

DMF 375422022

ANWITA DRUGS & CHEMICALS PVT LTDTAMSULOSIN HYDROCHLORIDE 0.2% SR PELLETS

DMF 417422025

ASTELLAS PHARMA INCInactiveTAMSULOSIN HYDROCHLORIDE

DMF 117611995

ASTELLAS IRELAND CO LTDInactiveTAMSULOSIN HYDROCHLORIDE

DMF 138781998

DR REDDYS LABORATORIES LTDInactiveTAMSULOSIN HYDROCHLORIDE

DMF 172472004

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveTAMSULOSIN HYDROCHLORIDE USP

DMF 178652004

TAI HENG INDUSTRY CO LTDInactiveTAMSULOSIN HYDROCHLORIDE

DMF 180672005

CIPLA LTDInactiveTAMSULOSIN HYDROCHLORIDE

DMF 181792005

ZENTIVA KSInactiveTAMSULOSIN HYDROCHLORIDE

DMF 181862005

MAPRIMED SAInactiveTAMSULOSIN HYDROCHLORIDE

DMF 182472005

NATCO PHARMA LTDInactiveTAMSULOSIN HYDROCHLORIDE

DMF 183922005

ZAMBON SAInactiveTAMSULOSIN HYDROCHLORIDE

DMF 188892005

RAGACTIVES SLInactiveTAMSULOSIN HYDROCHLORIDE

DMF 198772006

PCASInactiveTAMSULOSIN HYDROCHLORIDE

DMF 202902007

GEDEON RICHTER PLCInactiveTAMSULOSIN HYDROCHLORIDE

DMF 202912007

HOVIONE FARMACIENCIA SAInactiveTAMSULOSIN HYDROCHLORIDE

DMF 218032008

FERMION OYInactiveTAMSULOSIN HYDROCHLORIDE

DMF 235952010

JIANGSU HENGRUI MEDICINE CO LTDInactiveTAMSULOSIN HYDROCHLORIDE USP, NON-STERILE, BULK SUBSTANCE

DMF 236952010

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDInactiveTAMSULOSIN HYDROCHLORIDE

DMF 301102015

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Feb 13, 2019	SUPPL -33	View Letter (PDF)
Oct 22, 2014	SUPPL -29	View Letter (PDF)
Jul 24, 2014	SUPPL -28	View Letter (PDF)
Jul 27, 2011	SUPPL -27	View Letter (PDF)
Dec 29, 2009	SUPPL -26	View Letter (PDF)
Nov 19, 2009	SUPPL -25	View Letter (PDF)
Dec 4, 2008	SUPPL -24	View Letter (PDF)
May 5, 2008	SUPPL -23	View Letter (PDF)
Feb 23, 2007	SUPPL -21	View Letter (PDF)
Jan 16, 2007	SUPPL -20	View Letter (PDF)
Oct 25, 2005	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.4MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 15, 1997

No patent or exclusivity listings for this strength.