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Serving leading biopharmaceutical companies globally:

Cerilliant
Daiichi Sankyo
Mallinckrodt
Healthtrust
Teva
Fish and Richardson
US Department of Justice
Chinese Patent Office
Accenture
Medtronic

Generated: January 24, 2018

DrugPatentWatch Database Preview

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 Roche, Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Mylan Labs Ltd, Sagent Pharms, Sun Pharm Inds Ltd, Hoffmann La Roche, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Sun Pharm Industries, and Watson Labs Teva, and is included in seventeen NDAs. There are five 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 fifty-three patent family members in forty countries.

There are sixteen drug master file entries for ibandronate sodium. Fifteen suppliers are listed for this compound. There are two tentative approvals for this compound.
Pharmacology for ibandronate sodium
Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
Tentative approvals for IBANDRONATE SODIUM
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe2.5MGTABLET; ORAL
➤ Subscribe➤ Subscribe1MGINJECTABLE; INJECTION

US Patents and Regulatory Information for ibandronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Industries IBANDRONATE SODIUM ibandronate sodium TABLET;ORAL 078996-001 Aug 15, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Dr Reddys Labs Ltd IBANDRONATE SODIUM ibandronate sodium TABLET;ORAL 078997-001 Apr 30, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex Inc IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 204222-001 Oct 16, 2015 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Accord Hlthcare IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 206058-001 Feb 5, 2016 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Labs Ltd IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 202671-001 Sep 2, 2014 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sun Pharm Inds Ltd IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 090853-001 Feb 14, 2014 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sagent Pharms IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 202235-001 Sep 2, 2014 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 ibandronate sodium

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

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

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International Patents for ibandronate sodium

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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
QuintilesIMS
Citi
Federal Trade Commission
Medtronic
Queensland Health
Harvard Business School
Covington

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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