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Last Updated: February 3, 2023

Ibandronate sodium - Generic Drug Details


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What are the generic drug sources for ibandronate sodium and what is the scope of freedom to operate?

Ibandronate sodium is the generic ingredient in two branded drugs marketed by Roche, Accord Hlthcare, Apotex, Emcure Pharms Ltd, Eugia Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sun Pharm, Hoffmann La Roche, Apotex Inc, Aurobindo Pharma, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Orbion Pharms, Sun Pharm Industries, and Watson Labs Teva, and is included in eighteen NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ibandronate sodium has seventy-one patent family members in thirty-two countries.

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

Drug Prices for ibandronate sodium

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Recent Clinical Trials for ibandronate sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Southwest Oncology Group
National Cancer Institute (NCI)
Dr. Reddy's Laboratories LimitedPhase 1

See all ibandronate sodium clinical trials

Generic filers with tentative approvals for IBANDRONATE SODIUM
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing2.5MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing1MGINJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ibandronate sodium
Drug ClassBisphosphonate
Paragraph IV (Patent) Challenges for IBANDRONATE SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BONIVA Injection ibandronate sodium 1 mg/mL, 3 mL Vial 021858 1 2007-08-31
BONIVA Tablets ibandronate sodium 2.5 mg 021455 1 2007-05-16

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
Macleods Pharms Ltd IBANDRONATE SODIUM ibandronate sodium TABLET;ORAL 206887-001 Oct 31, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys Labs Ltd IBANDRONATE SODIUM ibandronate sodium TABLET;ORAL 078997-001 Apr 30, 2012 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 204222-001 Oct 16, 2015 AP RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ibandronate sodium

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

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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 verification 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.