FLOMAX Drug Patent Profile

When do Flomax patents expire, and when can generic versions of Flomax launch?

Flomax is a drug marketed by Sanofi and is included in one NDA.

The generic ingredient in FLOMAX is tamsulosin hydrochloride. There are thirty-three drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flomax

A generic version of FLOMAX was approved as tamsulosin hydrochloride by IMPAX LABS on March 2^nd, 2010.

Summary for FLOMAX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	46
Patent Applications:	1,795
Drug Prices:	Drug price information for FLOMAX
Drug Sales Revenues:	Drug sales revenues for FLOMAX
What excipients (inactive ingredients) are in FLOMAX?	FLOMAX excipients list
DailyMed Link:	FLOMAX at DailyMed

See drug prices for FLOMAX

See drug sales revenues for FLOMAX

Recent Clinical Trials for FLOMAX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hackensack Meridian Health	N/A
St. Joseph's Healthcare Hamilton	Phase 4
NeoTract, Inc.	Phase 4

See all FLOMAX clinical trials

Pharmacology for FLOMAX

Drug Class	alpha-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists

Paragraph IV (Patent) Challenges for FLOMAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FLOMAX	Capsules	tamsulosin hydrochloride	0.4 mg	020579	1	2004-12-20

US Patents and Regulatory Information for FLOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997	AB	RX	Yes	Yes

Expired US Patents for FLOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997

International Patents for FLOMAX

See the table below for patents covering FLOMAX around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	552794
U.S.S.R.	1248533	"CПOCOБ ПOЛУЧEHИЯ CУЛЬФAMOИЛЗAMEЩEHHЫX ПPOИЗBOДHЫX ФEHЭTИЛAMИHA ИЛИ EГO COЛЯHOKИCЛOЙ COЛИ" (METHOD OF PRODUCING SULFAMOYL-SUBSTITUTED DERIVATIVES OF PHENETHYLAMINE OR HYDROCHLORIDE THEREOF)
U.S.S.R.	1181540	"CПOCOБ ПOЛУЧEHИЯ CУЛЬФAMOИЛЗAMEЩEHHOГO ПPOИЗBOДHOГO ФEHЭTИЛAMИHA И EГO KИCЛOTHOЙ COЛИ" (METHOD OF PRODUCING SULFAMOYL-SUBSTITUTED DERIVATIVES OF PHENETHYLAMINE AND ITS ACID SALT)
U.S.S.R.	1082320	PROCESS FOR PREPARING SULFAMOYL-SUBSTITUTED DERIVATIVES OF PHENYL-ETHYL AMINE AND THEIR ACID ADDITION SALTS
European Patent Office	0194838	CONTROLLED-RELEASE PHARMACEUTICAL FORMULATION
South Africa	8601565

Supplementary Protection Certificates for FLOMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0034432	96C0048	Belgium		PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0034432	SPC/GB96/017: EXPIRE	United Kingdom		SPC/GB96/017: EXPIRES: 20060201