TAMSULOSIN HYDROCHLORIDE - Generic Drug Details

✉ Email this page to a colleague

What are the generic drug sources for tamsulosin hydrochloride and what is the scope of freedom to operate?

Tamsulosin hydrochloride is the generic ingredient in two branded drugs marketed by Sanofi, Alkem Labs Ltd, Ascent Pharms Inc, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Impax Labs, Macleods Pharms Ltd, Norvium Bioscience, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Wockhardt, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for tamsulosin hydrochloride. Forty-three suppliers are listed for this compound.

Summary for TAMSULOSIN HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	15
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	201
Patent Applications:	2,963
What excipients (inactive ingredients) are in TAMSULOSIN HYDROCHLORIDE?	TAMSULOSIN HYDROCHLORIDE excipients list
DailyMed Link:	TAMSULOSIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TAMSULOSIN HYDROCHLORIDE

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

Sponsor	Phase
Hackensack Meridian Health	N/A
NorthShore University HealthSystem	Phase 3
Benha University	N/A

See all TAMSULOSIN HYDROCHLORIDE clinical trials

Pharmacology for TAMSULOSIN HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for TAMSULOSIN HYDROCHLORIDE

G04CA	Alpha-adrenoreceptor antagonists
G04C	DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for TAMSULOSIN HYDROCHLORIDE

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 TAMSULOSIN HYDROCHLORIDE

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	077630-001	Apr 27, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wockhardt	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	078938-001	Apr 27, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	090377-001	Mar 2, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms Usa Inc	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	078225-001	Apr 27, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for TAMSULOSIN HYDROCHLORIDE

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997	⤷ Sign Up	⤷ Sign Up
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997	⤷ Sign Up	⤷ Sign Up
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997	⤷ Sign Up	⤷ Sign Up
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579-001	Apr 15, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.