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Last Updated: November 24, 2024

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE - Generic Drug Details


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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
Recent Clinical Trials for DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

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

SponsorPhase
Beth Israel Deaconess Medical CenterN/A
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)N/A
Ministry of Health, FrancePhase 3

See all DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE clinical trials

Pharmacology for DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Waylis Therap JALYN dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 022460-001 Jun 14, 2010 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 202509-001 Feb 26, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 207769-001 May 24, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 213300-001 Jul 18, 2024 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 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 ⤷  Sign Up ⤷  Sign Up
Waylis Therap JALYN dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 022460-001 Jun 14, 2010 ⤷  Sign Up ⤷  Sign Up
Waylis Therap JALYN dutasteride; tamsulosin hydrochloride CAPSULE;ORAL 022460-001 Jun 14, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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