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Serving leading biopharmaceutical companies globally:

Healthtrust
Cipla
Queensland Health
McKesson
Farmers Insurance
Merck
Mallinckrodt
Fuji
Chubb
Harvard Business School

Generated: February 19, 2018

DrugPatentWatch Database Preview

BONIVA Drug Profile

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When do Boniva patents expire, and when can generic versions of Boniva launch?

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

This drug has one hundred and fourteen 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. Additional details are available on the ibandronate sodium profile page.
Drug patent expirations by year for BONIVA
Pharmacology for BONIVA
Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

US Patents and Regulatory Information for BONIVA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for BONIVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 ➤ Sign Up ➤ Sign Up
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for BONIVA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 1 mg/mL, 3 mL Vial ➤ Subscribe 8/31/2007
➤ Subscribe Tablets 2.5 mg and 150 mg ➤ Subscribe 5/16/2007

Premature patent expiration for: BONIVA

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
➤ Sign Up BONIVA ➤ Sign Up

Non-Orange Book US Patents for 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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for BONIVA

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Merck
Cantor Fitzgerald
McKinsey
Accenture
Fuji
Daiichi Sankyo
Farmers Insurance
Healthtrust

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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