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Generated: July 16, 2018

DrugPatentWatch Database Preview

Balsalazide disodium - Generic Drug Details

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What are the generic sources for balsalazide disodium and what is the scope of balsalazide disodium freedom to operate?

Balsalazide disodium
is the generic ingredient in three branded drugs marketed by Apotex Inc, Mylan, West-ward Pharms Int, Valeant Pharms Intl, and Par Pharm Inc, and is included in six NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Balsalazide disodium has fifty-seven patent family members in nineteen countries.

There are ten drug master file entries for balsalazide disodium. Ten suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for balsalazide disodium
Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate
Synonyms for balsalazide disodium
(3E)-3-[[4-(2-carboxyethylcarbamoyl)phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylic acid
(3Z)-3-[[4-(2-carboxyethylcarbamoyl)phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylic acid
(3Z)-3-[[4-(2-carboxyethylcarbamoyl)phenyl]hydrazono]-6-oxo-cyclohexa-1,4-diene-1-carboxylic acid
(E)-5-((4-(((2-Carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxybenzoic acid
(E)-5-((4-((2-Carboxyethyl)carbamoyl)phenyl)diazenyl)-2-hydroxybenzoicacid
(E)-5-((p-((2-Carboxyethyl)carbamoyl)phenyl)azo)salicylic acid, disodium salt, dihydrate
(E)-5-({p-[(2-carboxyethyl)carbamoyl]phenyl}azo)-2-salicylic acid
(E)-5-[[4-[[(2-Carboxyethyl)amino]-carbonyl]phenyl]azo-2-hydroxybenzoic acid
(E)-5-[[4-[[(2-Carboxyethyl)amino]carbonyl]phenyl]azo]-2-hydroxybenzoic Acid
(Z)-3-(2-(4-((2-carboxyethyl)carbamoyl)phenyl)hydrazono)-6-oxocyclohexa-1,4-diene-1-carboxylic acid
150399-21-6
15ASW03C9S
1XL6BJI034
213594-60-6
3-(2-{4-[(2-carboxyethyl)carbamoyl]phenyl}hydrazinylidene)-6-oxocyclohexa-1,4-diene-1-carboxylic acid
399030-81-0
399B216
5-((4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxy-benzoicaci(e
5-(2-{4-[(2-carboxyethyl)carbamoyl]phenyl}diazen-1-yl)-2-hydroxybenzoic acid
5-[(1E)-2-[4-[[(2-Carboxyethyl)amino]carbonyl]phenyl]diazenyl]-2-hydroxybenzoic Acid
5-[(E)-{4-[(2-carboxyethyl)carbamoyl]phenyl}diazenyl]-2-hydroxybenzoic acid
5-[4-(2-carboxy-ethylcarbamoyl)-phenylazo]-2-hydroxy-benzoic acid
5-[4-(2-Carboxyethylcarbamoyl)phenylazo]salicylic acid
5-[4-(2-Carboxyethylcarbamoyl)phenylazo]salicylic Acid Disodium Salt
573B042
80573-04-2
82101-18-6
A815288
AB0020029
AB01209737-01
AC-4280
AC-8500
AC1NSFNR
AC1NUNBZ
AC1NUNZE
AC1O3RJF
AC1O6Q0Y
AC1O6Y3M
AK-51728
AKOS015892568
AKOS015896484
AKOS015907895
AKOS015962308
AKOS016339611
AKOS025294907
Ambap80573-04-2
AN-12139
AN-29767
AN-7937
AN-8640
API0000414
API0001585
AS-17568
Bacitracin zinc, Antibiotic for Culture Media Use Only
Balsalazida
Balsalazida [Spanish]
BALSALAZIDE
Balsalazide (INN)
Balsalazide (sodium hydrate)
Balsalazide [INN:BAN]
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
Balsalazidedisodium
Balsalazido
Balsalazido [Spanish]
Balsalazidum
Balsalazidum [Latin]
balsalazine
balsalzide Disodium
Balzide
benzoic acid, 5-((1e)-(4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxy-
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-, (E)-
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
BIDD:GT0772
bisalazide sodique
bisalazine disodium
BSZ
BX 661A
BX-661A
BX661A
C-22326
C17H13N3Na2O4
C17H13N3Na2O6
C17H13N3O6.2Na.2H2O
C17H15N3O6
CAS-80573-04-2
CCG-101140
CCG-213078
CHEBI:267413
CHEBI:59164
CHEBI:94605
CHEMBL1200760
CHEMBL1201346
CHEMBL1208641
Colazal
Colazal (TN)
Colazide
Colazide (TN)
CPD000469221
CS-2899
CS-4522
CTK8E6676
D02715
D07488
D0A6KR
DB01014
disodium (3E)-3-[[4-[(3-oxido-3-oxopropyl)carbamoyl]phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylate
disodium (3E)-3-[[4-[(3-oxido-3-oxopropyl)carbamoyl]phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylate dihydrate
DISODIUM (3Z)-3-(2-{4-[(2-CARBOXYLATOETHYL)CARBAMOYL]PHENYL}HYDRAZIN-1-YLIDENE)-6-OXOCYCLOHEXA-1,4-DIENE-1-CARBOXYLATE
disodium (3Z)-3-(2-{4-[(2-carboxylatoethyl)carbamoyl]phenyl}hydrazin-1-ylidene)-6-oxocyclohexa-1,4-diene-1-carboxylate dihydrate
disodium (3Z)-3-[[4-(2-carboxylatoethylcarbamoyl)phenyl]hydrazono]-6-oxo-cyclohexa-1,4-diene-1-carboxylate
disodium (3Z)-3-[[4-(2-carboxylatoethylcarbamoyl)phenyl]hydrazono]-6-oxo-cyclohexa-1,4-diene-1-carboxylate dihydrate
disodium (3Z)-3-[[4-[(3-oxido-3-oxopropyl)carbamoyl]phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylate
disodium (3Z)-3-[[4-[(3-oxido-3-oxopropyl)carbamoyl]phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylate dihydrate
disodium 3-[[4-[(2-carboxylatoethylamino)-oxomethyl]phenyl]hydrazinylidene]-6-oxo-1-cyclohexa-1,4-dienecarboxylate
disodium 3-[[4-[(3-oxidanidyl-3-oxidanylidene-propyl)carbamoyl]phenyl]hydrazinylidene]-6-oxidanylidene-cyclohexa-1,4-diene-1-carboxylate
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
DR001860
DR002702
DSSTox_CID_20653
DSSTox_GSID_40653
DSSTox_RID_79523
DTXSID7040653
FT-0622551
FT-0658348
Giazo
HMS2052K19
HMS2097A22
HMS2233C19
HMS3264M06
HY-B0667
HY-B0667A
I04-0033
I06-1923
J-008697
J-014008
K-4785
KB-209256
KS-5215
KS-5216
LS-173383
LS-36369
M003
MFCD18632541
MLS001424257
MolPort-005-934-178
MolPort-005-935-652
natrii balsalazidum
NC00390
NCGC00164634-01
NCGC00164634-02
NE31766
NSC-760046
NSC760046
OR072032
OR223856
OR242055
OR343587
P80AL8J7ZP
Pharmakon1600-01502414
Q-200671
SAM001246804
SCHEMBL118300
SCHEMBL138311
SCHEMBL142548
SCHEMBL15841310
SCHEMBL30360
SCHEMBL3666408
SMR000469221
sodium 5-[(E)-{4-[(2-carboxylatoethyl)carbamoyl]phenyl}diazenyl]-2-hydroxybenzoate hydrate (2:1:2)
ST51053292
TC-149982
Tox21_112252
Tox21_112252_1
UNII-15ASW03C9S
UNII-1XL6BJI034
UNII-P80AL8J7ZP
V0740
VA10369
ZINC100056740
ZINC13863965
Tentative approvals for BALSALAZIDE DISODIUM
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial1.1GTABLET;ORAL

US Patents and Regulatory Information for balsalazide disodium

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Expired US Patents for balsalazide disodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for balsalazide disodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,921,344 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Healthtrust
Citi
Federal Trade Commission
Boehringer Ingelheim
Deloitte
Merck
Chubb
Cerilliant

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 verifification 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.