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Generated: May 24, 2017

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Ibandronate sodium - Generic Drug Details

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What are the generic sources for ibandronate sodium and what is the scope of ibandronate sodium patent protection?

Ibandronate sodium
is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Watson Labs Inc, Apotex Inc, Sagent Pharms, Sun Pharm Inds Ltd, Hoffmann La Roche, Roche, Accord Hlthcare, Mylan Labs Ltd, Emcure Pharms Ltd, Mylan Pharms Inc, Sun Pharm Inds, Dr Reddys Labs Ltd, and Orchid Hlthcare, and is included in sixteen NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ibandronate sodium has one hundred and forty-three patent family members in forty countries.

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

Summary for Generic Name: ibandronate sodium

Drug Master File Entries: see list16
Suppliers / Packagers: see list14
Bulk Api Vendors: see list129
Clinical Trials: see list948
Patent Applications: see list5,839
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ibandronate sodium at DailyMed

Pharmacology for Ingredient: ibandronate sodium

Drug ClassBisphosphonate

Tentative approvals for IBANDRONATE SODIUM

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe2.5MGTABLET; ORAL
► Subscribe► Subscribe1MGINJECTABLE; INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orchid Hlthcare
ibandronate sodium
TABLET;ORAL078998-001Mar 19, 2012ABRXNoNo► Subscribe► Subscribe
Hoffmann La Roche
ibandronate sodium
TABLET;ORAL021455-001May 16, 2003DISCNYesNo6,143,326► Subscribe ► Subscribe
Apotex Inc
ibandronate sodium
TABLET;ORAL078948-001Mar 19, 2012ABRXNoNo► Subscribe► Subscribe
Hoffmann La Roche
ibandronate sodium
TABLET;ORAL021455-002Mar 24, 2005ABRXYesYes7,410,957► Subscribe ► Subscribe
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 2006APRXYesYes► Subscribe► Subscribe
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