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Ibandronate sodium - Generic Drug Details

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Ibandronate sodium is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Watson Labs Inc, Apotex Inc, Sagent Pharms, Sun Pharm Inds Ltd, Hoffmann La Roche, Roche, Accord Hlthcare, Mylan Labs Ltd, Emcure Pharms Ltd, Mylan Pharms Inc, Sun Pharm Inds, Dr Reddys Labs Ltd, and Orchid Hlthcare, and is included in sixteen NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and forty-one patent family members in forty countries.

There are sixteen drug master file entries for ibandronate sodium. Sixteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: ibandronate sodium

Tradenames:2
Patents:5
Applicants:14
NDAs:16
Drug Master File Entries: see list16
Suppliers / Packaging: see list16
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ibandronate sodium

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Tentative approvals for IBANDRONATE SODIUM

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL2.5MG
<disabled><disabled>INJECTABLE; INJECTION1MG

Clinical Trials for: ibandronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-001May 16, 2003DISCNNo6,143,326<disabled> <disabled>
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-001May 16, 2003DISCNNo6,294,196<disabled>Y <disabled>
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-002Mar 24, 2005RXYes7,718,634<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: ibandronate sodium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche
BONIVA
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 20064,927,814<disabled>
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-001May 16, 20034,927,814<disabled>
Roche
BONIVA
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 20065,662,918<disabled>
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Non-Orange Book Patents for Generic Ingredient: ibandronate sodium

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
6,627,221 Pharmaceutical composition containing diphosphonic acid or salt thereof<disabled in preview>
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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: ibandronate sodium

Country Document Number Estimated Expiration
Peru10822000<disabled in preview>
Denmark1117412<disabled in preview>
European Patent Office0998932<disabled in preview>
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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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