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

Sponsor	Phase
Beth Israel Deaconess Medical Center	N/A
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A
Gundersen Lutheran Medical Foundation	Phase 4

See all ALFUZOSIN HYDROCHLORIDE clinical trials

Pharmacology for ALFUZOSIN HYDROCHLORIDE

Drug Class	alpha-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ALFUZOSIN HYDROCHLORIDE

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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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
Sun Pharm	ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079057-001	Jul 18, 2011	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 ALFUZOSIN HYDROCHLORIDE

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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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