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Last Updated: November 4, 2024

Alfuzosin hydrochloride - Generic Drug Details


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What are the generic drug sources for alfuzosin hydrochloride and what is the scope of freedom to operate?

Alfuzosin hydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Norvium Bioscience, Sun Pharm, Torrent Pharms, Unichem, Wockhardt, and Concordia, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for alfuzosin hydrochloride. Twelve suppliers are listed for this compound.

Summary for alfuzosin hydrochloride
US Patents:0
Tradenames:2
Applicants:10
NDAs:10
Drug Master File Entries: 19
Finished Product Suppliers / Packagers: 12
Raw Ingredient (Bulk) Api Vendors: 104
Clinical Trials: 45
Patent Applications: 412
What excipients (inactive ingredients) are in alfuzosin hydrochloride?alfuzosin hydrochloride excipients list
DailyMed Link:alfuzosin hydrochloride at DailyMed
Recent Clinical Trials for alfuzosin 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
Gundersen Lutheran Medical FoundationPhase 4

See all alfuzosin hydrochloride clinical trials

Pharmacology for alfuzosin hydrochloride
Paragraph IV (Patent) Challenges for ALFUZOSIN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
UROXATRAL Extended-release Tablets alfuzosin hydrochloride 10 mg 021287 9 2007-06-12

US Patents and Regulatory Information for alfuzosin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent Pharms ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079054-001 Jul 18, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex Inc ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079013-001 Jul 18, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079014-001 Jul 18, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Invagen Pharms ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 090284-001 Jan 17, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Wockhardt ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 090221-001 Aug 10, 2012 DISCN 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 alfuzosin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Concordia UROXATRAL alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021287-001 Jun 12, 2003 ⤷  Sign Up ⤷  Sign Up
Concordia UROXATRAL alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021287-001 Jun 12, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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