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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Colorcon
Harvard Business School
Farmers Insurance
McKinsey
Baxter
Covington
Daiichi Sankyo

Generated: May 20, 2018

DrugPatentWatch Database Preview

GIAZO Drug Profile

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When do Giazo patents expire, and what generic alternatives are available?

Giazo is a drug marketed by Valeant Pharms Intl and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-seven patent family members in nineteen countries.

The generic ingredient in GIAZO is balsalazide disodium. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.
Summary for GIAZO
Drug patent expirations by year for GIAZO
Pharmacology for GIAZO
Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate
Synonyms for GIAZO
15ASW03C9S
213594-60-6
5-[4-(2-Carboxyethylcarbamoyl)phenylazo]salicylic Acid Disodium Salt
82101-18-6
AC1NUNZE
AKOS015896484
API0000414
Balsalazide Disodium
Balsalazide Disodium Salt
Balsalazide disodium salt hydrate
Balsalazide sodium
Balsalazidedisodium
balsalazine
Balzide
BX-661A
C17H13N3Na2O6
CHEMBL1200760
disodium (3E)-3-[[4-[(3-oxido-3-oxopropyl)carbamoyl]phenyl]hydrazinylidene]-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
HMS2097A22
I06-1923
M003
OR072032
OR242055
ST51053292
UNII-15ASW03C9S

US Patents and Regulatory Information for GIAZO

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 GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 AB RX Yes Yes ➤ 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

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Paragraph IV (Patent) Challenges for GIAZO
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 1.1 g ➤ Subscribe 2013-11-05

Non-Orange Book US Patents for GIAZO

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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Covington
QuintilesIMS
Teva
Dow
McKinsey
Mallinckrodt
Colorcon
Cerilliant

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