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Ibandronate sodiumis 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.
Summary for ibandronate sodium
|Drug Master File Entries:||16|
|Suppliers / Packagers:||11|
|Bulk Api Vendors:||43|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for ibandronate sodium|
|DailyMed Link:||ibandronate sodium at DailyMed|
Recent Clinical Trials for ibandronate sodium
Identify potential brand extensions & 505(b)(2) entrants
|Dr. Reddy's Laboratories Limited||Phase 1|
|National Cancer Institute (NCI)||Phase 3|
|Southwest Oncology Group||Phase 3|
Generic filers with tentative approvals for IBANDRONATE SODIUM
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 Class||Bisphosphonate |
|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|
|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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