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Last Updated: March 19, 2024

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, Avet Lifesciences, 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. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for ibandronate sodium. Ten 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
⤷  Try a Trial⤷  Try a Trial2.5MGTABLET; ORAL
⤷  Try a Trial⤷  Try a 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 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
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 090853-001 Feb 14, 2014 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sagent Pharms Inc IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 202235-001 Sep 2, 2014 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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