TAMSULOSIN HYDROCHLORIDE - Generic Drug Details

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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-four 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:	44
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Ltd	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	090931-001	Jul 15, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	202433-001	Apr 30, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	077630-001	Apr 27, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	090408-001	Apr 27, 2010		DISCN	No	No	⤷ 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

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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

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