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Last Updated: April 3, 2020

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COLAZAL Drug Profile


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When do Colazal patents expire, and when can generic versions of Colazal launch?

Colazal is a drug marketed by Valeant Pharms Intl and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-seven patent family members in twelve countries.

The generic ingredient in COLAZAL is balsalazide disodium. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.

US ANDA Litigation and Generic Entry Outlook for Colazal

A generic version of COLAZAL was approved as balsalazide disodium by APOTEX INC on December 28th, 2007.

  Start Trial

Drug patent expirations by year for COLAZAL
Drug Prices for COLAZAL

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Recent Clinical Trials for COLAZAL

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

SponsorPhase
Roxane LaboratoriesN/A
Mylan PharmaceuticalsPhase 1

See all COLAZAL clinical trials

Recent Litigation for COLAZAL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Salix Pharmaceuticals, Inc. v. Apotex, Inc.2015-09-30
Salix Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc.2014-07-17

See all COLAZAL litigation

Synonyms for COLAZAL
(E)-5-((p-((2-Carboxyethyl)carbamoyl)phenyl)azo)salicylic acid, disodium salt, dihydrate
150399-21-6
15ASW03C9S
1XL6BJI034
213594-60-6
5-[(1E)-[4-[[(2-Carboxyethyl)Amino]Carbonyl]Phenyl]Azo]-2-Hydroxybenzoic Acid Disodium Salt
5-[4-(2-Carboxyethylcarbamoyl)phenylazo]salicylic Acid Disodium Salt
82101-18-6
A809040
A815288
AC-4280
AK175612
AKOS015896484
AKOS015907895
AKOS015962308
AKOS025294907
API0000414
API0001585
Balsalazide (sodium hydrate)
Balsalazide Disodium
Balsalazide disodium (USAN)
Balsalazide disodium [USAN:USP]
Balsalazide disodium [USAN]
BALSALAZIDE DISODIUM DIHYDRATE
Balsalazide disodium hydrate
Balsalazide Disodium Salt
Balsalazide disodium salt dihydrate
Balsalazide disodium salt hydrate
Balsalazide sodium
balsalazide-disodium
balsalazine
balsalzide Disodium
Balzide
Benzoic acid, 5-((1E)-(4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxy-, disodium salt
Benzoic acid, 5-((1E)-(4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxy-, disodium salt, dihydrate
Benzoic acid, 5-((4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxy-, disodium salt
Benzoic acid, 5-((4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxy-, disodium salt, dihydrate, (E)-
Benzoic Acid,5-((1E)-(4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxy-,disodium salt
bisalazide sodique
bisalazine disodium
BSZ
BX 661A
BX-661A
BX661A
C-22326
C17H13N3Na2O4
C17H13N3Na2O6
C17H13N3O6.2Na.2H2O
CCG-213078
CHEBI:59164
CHEMBL1200760
Colazide
Colazide (TN)
CS-4522
CTK8E6676
D02715
disodium 3-[[4-[(2-carboxylatoethylamino)-oxomethyl]phenyl]hydrazinylidene]-6-oxo-1-cyclohexa-1,4-dienecarboxylate
disodium 3-[[4-[(2-carboxylatoethylamino)-oxomethyl]phenyl]hydrazinylidene]-6-oxo-1-cyclohexa-1,4-dienecarboxylate dihydrate
disodium 3-[[4-[(3-oxidanidyl-3-oxidanylidene-propyl)carbamoyl]phenyl]hydrazinylidene]-6-oxidanylidene-cyclohexa-1,4-diene-1-carboxylate
disodium 3-[[4-[(3-oxidanidyl-3-oxidanylidene-propyl)carbamoyl]phenyl]hydrazinylidene]-6-oxidanylidene-cyclohexa-1,4-diene-1-carboxylate dihydrate
Disodium 5-((4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxybenzoate
disodium 5-((4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxybenzoate dihydrate
disodium 5-[(E)-{4-[(2-carboxylatoethyl)carbamoyl]phenyl}diazenyl]-2-hydroxybenzoate--water (1/2)
disodium 5-[4-(2-carboxyethylcarbamoyl)phenylazo]salicylate
disodium balsalazide
disodium,(3Z)-3-[[4-(2-carboxylatoethylcarbamoyl)phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylate
disodium;(3E)-3-[[4-(2-carboxylatoethylcarbamoyl)phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylate;dihydrate
FT-0602903
FT-0622551
FT-0658348
Giazo
HMS2097A22
HMS3264M06
HMS3714A22
HY-B0667A
J-008697
J-014008
K-4785
KS-5216
LS-173383
M003
MFCD18632541
natrii balsalazidum
Q27126501
Q27251713
SCHEMBL30360
SCHEMBL3666408
Sodium (E)-5-((4-((2-carboxylatoethyl)carbamoyl)phenyl)diazenyl)-2-hydroxybenzoate
sodium (E)-5-((4-(2-carboxylatoethylcarbamoyl)phenyl)diazenyl)-2-hydroxybenzoate dihydrate
sodium 5-[(E)-{4-[(2-carboxylatoethyl)carbamoyl]phenyl}diazenyl]-2-hydroxybenzoate hydrate (2:1:2)
SY016905
UNII-15ASW03C9S
UNII-1XL6BJI034

US Patents and Regulatory Information for COLAZAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Baxter
Johnson and Johnson
Medtronic
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.