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Last Updated: July 12, 2020

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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 freedom to operate?

Ibandronate sodium is the generic ingredient in two branded drugs marketed by Roche, Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Mylan Labs Ltd, Sagent Pharms Inc, Sun Pharm, Hoffmann La Roche, Apotex Inc, 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 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 sixteen 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

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SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1
National Cancer Institute (NCI)Phase 3
Southwest Oncology GroupPhase 3

See all ibandronate sodium clinical trials

Generic filers with tentative approvals for IBANDRONATE SODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial2.5MGTABLET; ORAL
  Start Trial  Start Trial1MGINJECTABLE; 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 NDA Submissiondate
BONIVA INJECTABLE;INTRAVENOUS ibandronate sodium 021858 2007-08-31
BONIVA TABLET;ORAL ibandronate sodium 021455 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
Accord Hlthcare IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 206058-001 Feb 5, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Emcure Pharms Ltd IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 203987-001 Sep 2, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Orchid Hlthcare IBANDRONATE SODIUM ibandronate sodium TABLET;ORAL 078998-001 Mar 19, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
>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 021455-002 Mar 24, 2005   Start Trial   Start Trial
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006   Start Trial   Start Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Dow
AstraZeneca
Moodys
McKinsey

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