Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Harvard Business School
McKesson
Mallinckrodt

Last Updated: November 18, 2019

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Alfuzosin hydrochloride - Generic Drug Details

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

Alfuzosin hydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, Aurobindo Pharma Ltd, Heritage Pharma, Invagen Pharms, Mylan, Sun Pharm, Torrent Pharms, Unichem Labs Ltd, Wockhardt Ltd, 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. Fifteen suppliers are listed for this compound.

Recent Clinical Trials for alfuzosin hydrochloride

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

SponsorPhase
Gundersen Lutheran Medical FoundationPhase 4
Swiss Group for Clinical Cancer ResearchPhase 2
Mayo ClinicPhase 2

See all alfuzosin hydrochloride clinical trials

Recent Litigation for alfuzosin hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Sanofi-Aventis v. Apotex Inc.2008-06-23
In re: Alfuzosin Hydrochloride Patent Litigation2008-06-09
Sanofi-Aventis v. Wockhardt Limited2008-03-14

See all alfuzosin hydrochloride litigation

Pharmacology for alfuzosin hydrochloride
Synonyms for alfuzosin hydrochloride
(+-)-N-(3-((4-Amino-6,7-dimethoxy-2-quinazolinyl)methylamino)propyl)tetrahydro-2-furamide monohydrochloride
(methyl)amino)propyl)tetrahydrofuran-2
133880-44-1
2-Furancarboxamide, N-(3-((4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino)propyl)tetrahydro-, monohydrochloride (+-)-
4-Amino-6,7-dimethoxy-2-[methyl[3-[(tetrahydro-2-furoyl)amino]propyl]amino]quinazoline Hydrochloride
403A681
81403-68-1
81403-80-7 (Parent)
A2591
AB0008072
AB2000094
AC-1116
AC1L2GRP
AC1Q5PED
AKOS015966770
Alfetim
Alfoten
Alfuzosin (hydrochloride)
Alfuzosin for peak identification, European Pharmacopoeia (EP) Reference Standard
Alfuzosin for system suitability A, European Pharmacopoeia (EP) Reference Standard
Alfuzosin for system suitability, European Pharmacopoeia (EP) Reference Standard
Alfuzosin HCl
Alfuzosin hydrochloride (JAN/USAN)
Alfuzosin hydrochloride (Uroxatral)
Alfuzosin hydrochloride [USAN:USP]
Alfuzosin hydrochloride [USAN]
Alfuzosin hydrochloride, >=98% (HPLC), solid
Alfuzosin hydrochloride, European Pharmacopoeia (EP) Reference Standard
Alfuzosin hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Alfuzosin hydrochloride, United States Pharmacopeia (USP) Reference Standard
Alfuzosin Hydrochloride,(S)
Alfuzosin hydrochloride;
API0001407
AS-14240
AT-12271
BC677639
BCP9000271
BCPP000417
C19H27N5O4
C19H28ClN5O4
CAS-81403-68-1
CC-23835
CCG-213373
CHEBI:32286
CHEMBL1723
CS-2087
CTK8F7637
D01692
DSSTox_CID_25514
DSSTox_GSID_45514
DSSTox_RID_80924
DTXSID3045514
FT-0630890
HMS1569A05
HY-B0192A
K448
KS-00000XK8
LP00224
LS-70107
MFCD00879135
MolPort-006-391-851
N-(3-((4-Amino-6,7-dimethoxy-2-quinazolinyl)methylamino)propyl)tetrahydro-2-furancarboxamide hydrochloride
N-(3-((4-amino-6,7-dimethoxyquinazolin-2-yl)
N-(3-((4-amino-6,7-dimethoxyquinazolin-2-yl)(methyl)amino)propyl)tetrahydrofuran-2-carboxamide hydrochloride
N-[3-[(4-Amino-6,7-dimethoxy-2-quinazolinyl)(methyl)amino]propyl]tetrahydro-2-furancarboxamide Hydrochloride
n-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino]propyl]tetrahydro-2-furancarboxamide hydrochloride
N-[3-[(4-Amino-6,7-dimethoxy-2-quinazolynyl)methylamino]propyl]tetrahydro-2-furancarboxamide hydrochloride
N-[3-[(4-amino-6,7-dimethoxyquinazolin-2-yl)-methylamino]propyl]oxolane-2-carboxamide hydrochloride
N-[3-[4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino]propyl]tetrahydro-2-furancarboxamide hydrochloride
n-{3-[(4-amino-6,7-dimethoxychinazolin-2-yl)(methyl)amino]propyl}tetrahydrofuran-2-carboxamidhydrochlorid
NCGC00016946-01
NCGC00095152-09
NCGC00260909-01
s1409
SCHEMBL179910
SL 77 499-10
SL 77499-10
SL-77.0499-10
SL-77499
SL-77499-10
SL-7749910
SL77.0499-10
SR-01000759345
SR-01000759345-5
SW196913-4
Tox21_110701
Tox21_110701_1
Tox21_500224
Urion
Uroxatral
Uroxatral (TN)
Uroxatral hydrochloride
Xatral
Xatral OD
Xatral Retard
Xatral SR
Xatral XL
YTNKWDJILNVLGX-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for ALFUZOSIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
UROXATRAL TABLET, EXTENDED RELEASE;ORAL alfuzosin hydrochloride 021287 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
Aurobindo Pharma Ltd ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079060-001 Aug 30, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079057-001 Jul 18, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharma ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079056-001 Jul 18, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Torrent Pharms ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079054-001 Jul 18, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Ltd ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 090221-001 Aug 10, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Invagen Pharms ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 090284-001 Jan 17, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079014-001 Jul 18, 2011 AB RX No No   Start Trial   Start Trial   Start 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 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   Start Trial   Start Trial
Concordia UROXATRAL alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021287-001 Jun 12, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Baxter
Johnson and Johnson
McKesson
Mallinckrodt

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