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Last Updated: July 27, 2021

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Tamsulosin hydrochloride - Generic Drug Details

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What are the generic drug sources for tamsulosin hydrochloride and what is the scope of patent protection?

Tamsulosin hydrochloride is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Alkem Labs Ltd, Anbison Lab, Anchen Pharms, Aurobindo Pharma Ltd, Impax Labs, Macleods Pharms Ltd, Mylan, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Wockhardt, and Zydus Pharms Usa Inc, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for tamsulosin hydrochloride
Recent Clinical Trials for tamsulosin hydrochloride

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

SponsorPhase
University of ArizonaPhase 2
Wake Forest University Health SciencesPhase 4
Johns Hopkins UniversityPhase 2

See all tamsulosin hydrochloride clinical trials

Pharmacology for tamsulosin hydrochloride
Paragraph IV (Patent) Challenges for TAMSULOSIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
FLOMAX CAPSULE;ORAL tamsulosin hydrochloride 020579 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
Sun Pharm Inds Ltd TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 090931-001 Jul 15, 2010 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Synthon Pharms TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 078801-001 Apr 27, 2010 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Teva Pharms TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 077630-001 Apr 27, 2010 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 090408-001 Apr 27, 2010 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Anchen Pharms TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 202010-001 Jan 4, 2013 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Macleods Pharms Ltd TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 204645-001 Jan 20, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579-001 Apr 15, 1997 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579-001 Apr 15, 1997 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579-001 Apr 15, 1997 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579-001 Apr 15, 1997 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Boehringer Ingelheim
Mallinckrodt
Moodys
McKinsey

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