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Serving leading biopharmaceutical companies globally:

Cipla
Queensland Health
Boehringer Ingelheim
Colorcon
Chinese Patent Office
Daiichi Sankyo
Moodys
Chubb
Johnson and Johnson
Citi

Generated: December 12, 2017

DrugPatentWatch Database Preview

COLAZAL Drug Profile

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Which patents cover Colazal, and what generic alternatives are available?

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-four patent family members in eleven countries.

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

Pharmacology for COLAZAL

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms IntlCOLAZALbalsalazide disodiumCAPSULE;ORAL020610-001Jul 18, 2000ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlCOLAZALbalsalazide disodiumCAPSULE;ORAL020610-001Jul 18, 2000ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Tradename: COLAZAL

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
8,921,344Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives► Subscribe
9,192,616Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: COLAZAL

Country Document Number Estimated Expiration
BrazilPI0717859► Subscribe
Mexico2008002283► Subscribe
Japan2012246322► Subscribe
Canada2816276► Subscribe
Japan2010509326► Subscribe
Australia2007322362► Subscribe
Japan2013032395► Subscribe
South Korea20090118906► Subscribe
China103948609► Subscribe
Israel189104► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Cipla
Accenture
Daiichi Sankyo
Healthtrust
QuintilesIMS
Mallinckrodt
Julphar
Cantor Fitzgerald
Medtronic
UBS

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.

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