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Serving 500+ biopharmaceutical companies globally:

Covington
Colorcon
Chubb
McKesson
Johnson and Johnson
Cantor Fitzgerald
Medtronic
Farmers Insurance
Queensland Health
Harvard Business School

Generated: September 26, 2017

DrugPatentWatch Database Preview

BONIVA Drug Profile

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What is the patent landscape for Boniva, and when can generic versions of Boniva launch?

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

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

The generic ingredient in BONIVA is ibandronate sodium. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed 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
Bulk Api Vendors: see list114
Clinical Trials: see list13
Patent Applications: see list5,852
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BONIVA at DailyMed

Pharmacology for Tradename: BONIVA

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-001May 16, 2003DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Roche
BONIVA
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 2006APRXYesYes► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-002Mar 24, 2005ABRXYesYes► Subscribe► Subscribe ► Subscribe
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-001May 16, 2003DISCNYesNo► Subscribe► Subscribe ► Subscribe
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-002Mar 24, 2005ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-002Mar 24, 2005ABRXYesYes► Subscribe► Subscribe ► Subscribe
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-002Mar 24, 2005ABRXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: BONIVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-001May 16, 2003► Subscribe► Subscribe
Roche
BONIVA
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 2006► Subscribe► Subscribe
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-002Mar 24, 2005► Subscribe► Subscribe
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-001May 16, 2003► Subscribe► Subscribe
Roche
BONIVA
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 2006► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
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BONIVA
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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
Poland329347► Subscribe
Cyprus1116233► Subscribe
Canada2346662► Subscribe
Australia722516► Subscribe
Argentina069942► Subscribe
Poland194552► Subscribe
South Korea20120065435► Subscribe
Portugal1880744► Subscribe
EcuadorSP045335► Subscribe
Argentina039978► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Cipla
QuintilesIMS
Argus Health
Fuji
Express Scripts
Medtronic
Daiichi Sankyo
Mallinckrodt
Julphar

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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