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Balsalazide disodium - Generic Drug Details

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Balsalazide disodium is the generic ingredient in three branded drugs marketed by Valeant Pharms Intl, Roxane, Mylan, Par Pharm Inc, and Apotex 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.

This ingredient has fifty-six patent family members in nineteen countries.

There are ten drug master file entries for balsalazide disodium. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: balsalazide disodium

Tradenames:3
Patents:7
Applicants:5
NDAs:6
Drug Master File Entries: see list10
Suppliers / Packaging: see list13
Therapeutic Class:Inflammatory Bowel Disease Agents
Drug Prices:see low prices

Pharmacology for Ingredient: balsalazide disodium

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Tentative approvals for BALSALAZIDE DISODIUM

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL1.1G
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane
BALSALAZIDE DISODIUM
balsalazide disodium
CAPSULE;ORAL077806-001Dec 28, 2007RXNo► subscribe► subscribe
Valeant Pharms Intl
GIAZO
balsalazide disodium
TABLET;ORAL022205-001Feb 3, 2012RXYes7,452,872► subscribe ► subscribe
Valeant Pharms Intl
GIAZO
balsalazide disodium
TABLET;ORAL022205-001Feb 3, 2012RXYes7,625,884► subscribe ► subscribe
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Expired Orange Book Patents for Generic Ingredient: balsalazide disodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Intl
COLAZAL
balsalazide disodium
CAPSULE;ORAL020610-001Jul 18, 20004,412,992*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,921,344Formulations 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 Ingredient: balsalazide disodium

Country Document Number Estimated Expiration
Canada2816276► subscribe
France2760638► subscribe
World Intellectual Property Organization (WIPO)2011137103► 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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