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Last Updated: March 19, 2024

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, Anchen Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Chartwell Rx, 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 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-two 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
Hackensack Meridian HealthN/A
NorthShore University HealthSystemPhase 3
Benha UniversityN/A

See all TAMSULOSIN HYDROCHLORIDE clinical trials

Pharmacology for TAMSULOSIN HYDROCHLORIDE
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
Sandoz TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 078015-001 Apr 27, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 090408-001 Apr 27, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride CAPSULE;ORAL 204645-001 Jan 20, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579-001 Apr 15, 1997 ⤷  Try a Trial ⤷  Try a Trial
Sanofi FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579-001 Apr 15, 1997 ⤷  Try a Trial ⤷  Try a Trial
Sanofi FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579-001 Apr 15, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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