DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE - Generic Drug Details

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

Dutasteride; tamsulosin hydrochloride is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Aurobindo Pharma, Endo Operations, Zydus Pharms, and Waylis Therap, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	6
Clinical Trials:	21
DailyMed Link:	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

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

Sponsor	Phase
Beth Israel Deaconess Medical Center	N/A
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A
Assistance Publique - Hôpitaux de Paris	Phase 3

See all DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE clinical trials

Pharmacology for DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Drug Class	5-alpha Reductase Inhibitor alpha-Adrenergic Blocker
Mechanism of Action	5-alpha Reductase Inhibitors Adrenergic alpha-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

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

G04CB	Testosterone-5-alpha reductase inhibitors
G04C	DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JALYN	Capsules	dutasteride; tamsulosin hydrochloride	0.5 mg/0.4 mg	022460	1	2010-10-26

US Patents and Regulatory Information for DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs Fl Inc	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	202975-001	Nov 20, 2015		DISCN	No	No
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010	AB	RX	Yes	Yes
Zydus Pharms	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	207769-001	May 24, 2018	AB	RX	No	No
Endo Operations	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	202509-001	Feb 26, 2014	AB	RX	No	No
Aurobindo Pharma	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	213300-001	Jul 18, 2024	AB	RX	No	No

Expired US Patents for DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010