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Generated: July 23, 2017

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Ibandronate sodium - Generic Drug Details

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What are the generic drug sources for ibandronate sodium and what is the scope of ibandronate sodium patent protection?

Ibandronate sodium
is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Watson Labs Teva, 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 six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ibandronate sodium has one hundred and forty-three patent family members in forty countries.

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

Summary for Generic Name: ibandronate sodium

Tradenames:2
Patents:6
Applicants:14
NDAs:16
Drug Master File Entries: see list16
Suppliers / Packagers: see list14
Bulk Api Vendors: see list129
Clinical Trials: see list2,427
Patent Applications: see list5,839
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ibandronate sodium at DailyMed

Pharmacology for Ingredient: ibandronate sodium

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Tentative approvals for IBANDRONATE SODIUM

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe2.5MGTABLET; ORAL
► Subscribe► Subscribe1MGINJECTABLE; INJECTION
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;ORAL021455-002Mar 24, 2005ABRXYesYes7,192,938► Subscribe ► Subscribe
Sun Pharm Inds
IBANDRONATE SODIUM
ibandronate sodium
TABLET;ORAL078996-001Aug 15, 2012ABRXNoNo► Subscribe► Subscribe
Sun Pharm Inds Ltd
IBANDRONATE SODIUM
ibandronate sodium
INJECTABLE;INTRAVENOUS090853-001Feb 14, 2014APRXNoNo► Subscribe► Subscribe
Sagent Pharms
IBANDRONATE SODIUM
ibandronate sodium
INJECTABLE;INTRAVENOUS202235-001Sep 2, 2014APRXNoNo► Subscribe► Subscribe
Orchid Hlthcare
IBANDRONATE SODIUM
ibandronate sodium
TABLET;ORAL078998-001Mar 19, 2012ABRXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ibandronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
Roche
BONIVA
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 20065,662,918► Subscribe
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-001May 16, 20036,143,326► Subscribe
Roche
BONIVA
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 20064,927,814► Subscribe
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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► 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: ibandronate sodium

Country Document Number Estimated Expiration
Japan5813911► Subscribe
Argentina039978► Subscribe
Czech Republic9803364► Subscribe
Japan2013166773► Subscribe
Japan5557989► 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:

Baxter
Fish and Richardson
Accenture
Mallinckrodt
Chinese Patent Office
McKesson
Queensland Health
Chubb
US Department of Justice
AstraZeneca

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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