TAMSULOSIN HYDROCHLORIDE Drug Patent Profile

When do Tamsulosin Hydrochloride patents expire, and what generic alternatives are available?

Tamsulosin Hydrochloride is a drug marketed by 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 fourteen NDAs.

The generic ingredient in TAMSULOSIN HYDROCHLORIDE 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 Tamsulosin Hydrochloride

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

Summary for TAMSULOSIN HYDROCHLORIDE

US Patents:	0
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	201
Patent Applications:	1,795
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	207405-001	Aug 11, 2017	AB	RX	No	No
Macleods Pharms Ltd	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	204645-001	Jan 20, 2017	AB	RX	No	No
Chartwell Rx	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	211885-001	Oct 17, 2019	AB	RX	No	No
Teva Pharms	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	077630-001	Apr 27, 2010	AB	RX	No	No
Norvium Bioscience	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	090408-001	Apr 27, 2010		DISCN	No	No
Zydus Pharms Usa Inc	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	078225-001	Apr 27, 2010	AB	RX	No	No
Ascent Pharms Inc	TAMSULOSIN HYDROCHLORIDE	tamsulosin hydrochloride	CAPSULE;ORAL	214730-001	May 4, 2022		DISCN	No	No