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Generated: May 22, 2017

DrugPatentWatch Database Preview

Details for Patent: 7,625,884

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Which drugs does patent 7,625,884 protect, and when does it expire?


Patent 7,625,884 protects GIAZO and COLAZAL and is included in two NDAs. There has been one Paragraph IV challenge on Giazo.

Protection for COLAZAL has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-four patent family members in eleven countries.

Summary for Patent: 7,625,884

Title:Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Abstract:A method of increasing the bioavailability of balsalazide by administration of an oral dosage form with food is provided, as well as an article of manufacture comprising an oral dosage form of balsalazide in a suitable container and associated with printed labeling which describes the increased bioavailability of the medication in the container when taken with food.
Inventor(s): Johnson; Lorin (Palo Alto, CA)
Assignee: Salix Pharmaceuticals, Ltd (Morrisville, NC)
Application Number:11/877,589
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Valeant Pharms Intl
GIAZO
balsalazide disodium
TABLET;ORAL022205-001Feb 3, 2012ABRXYesYes7,625,884► Subscribe TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
Valeant Pharms Intl
COLAZAL
balsalazide disodium
CAPSULE;ORAL020610-001Jul 18, 2000ABRXYesYes7,625,884*PED► SubscribeY
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Non-Orange Book Patents for Patent: 7,625,884

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
9,192,616Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives► Subscribe
7,452,872Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives► Subscribe
8,921,344Formulations 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 Patent: 7,625,884

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office2586427► Subscribe
European Patent Office2529729► Subscribe
European Patent Office2096912► Subscribe
European Patent Office1931354► Subscribe
China105267226► 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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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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