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Last Updated: March 19, 2024

IBANDRONATE SODIUM Drug Patent Profile


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Which patents cover Ibandronate Sodium, and when can generic versions of Ibandronate Sodium launch?

Ibandronate Sodium is a drug marketed by Accord Hlthcare, Apotex, Avet Lifesciences, Eugia Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sun Pharm, 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 sixteen NDAs.

The generic ingredient in IBANDRONATE SODIUM is ibandronate sodium. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ibandronate Sodium

A generic version of IBANDRONATE SODIUM was approved as ibandronate sodium by APOTEX INC on March 19th, 2012.

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Drug patent expirations by year for IBANDRONATE SODIUM
Drug Prices for IBANDRONATE SODIUM

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Recent Clinical Trials for IBANDRONATE SODIUM

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

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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
Accord Hlthcare IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 206058-001 Feb 5, 2016 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
Eugia Pharma IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 205332-001 Aug 19, 2015 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

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