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BONIVA Drug Profile

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Boniva is a drug marketed by Hoffmann La Roche and Roche and is included in two NDAs. It is available from two suppliers. There are five patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in BONIVA is ibandronate sodium. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the ibandronate sodium profile page.

Summary for Tradename: BONIVA

Patents:5
Applicants:2
NDAs:2
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: BONIVA

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
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► subscribe ► subscribe
Roche
BONIVA
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 2006RXYes► subscribe► subscribe
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-002Mar 24, 2005RXYes7,410,957► subscribe ► subscribe
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Expired Patents for Tradename: BONIVA

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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► subscribe
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-002Mar 24, 20054,927,814► subscribe
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-001May 16, 20034,927,814► subscribe
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Paragraph IV activity for: BONIVA

Drugname Dosage Strength RLD Submissiondate
ibandronate sodiumInjection1 mg/mL, 3 mL VialBoniva8/31/2007
ibandronate sodiumTablets2.5 mg and 150 mgBoniva5/16/2007

Premature patent expiration for: BONIVA

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
7,410,957
BONIVA
August 12, 2016

Non-Orange Book Patents for Tradename: BONIVA

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► 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: BONIVA

Country Document Number Estimated Expiration
Japan2002527398► subscribe
Brazil0308901► subscribe
Czech Republic299008► 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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