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Details for Generic Name: ibandronate sodium

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

This ingredient has one hundred and fifty-one patent family members in forty-one countries.

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

Summary for Generic Name: ibandronate sodium

Tradenames:2
Patents:6
Applicants:13
NDAs:14
Drug Master File Entries: see list16
Suppliers / Packaging: see list5
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for Ingredient: ibandronate sodium

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Tentative approvals for IBANDRONATE SODIUM

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL2.5MG
<disabled><disabled>INJECTABLE; INJECTION1MG

Clinical Trials for: ibandronate sodium

Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition
Status: Completed Condition: Healthy

A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia
Status: Completed Condition: Postmenopausal Osteoporosis

A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis
Status: Completed Condition: Postmenopausal Osteoporosis

BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )
Status: Completed Condition: Osteoporosis

Study Comparing Ibandronate Versus Placebo in Hip Osteonecrosis
Status: Recruiting Condition: Aseptic;; Hip Necrosis

A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
Status: Completed Condition: Post Menopausal Osteoporosis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-002Mar 24, 2005RXYes7,192,938<disabled> <disabled>
Mylan Pharms Inc
IBANDRONATE SODIUM
ibandronate sodium
TABLET;ORAL078995-001Mar 19, 2012RXNo<disabled><disabled>
Apotex Inc
IBANDRONATE SODIUM
ibandronate sodium
TABLET;ORAL078948-001Mar 19, 2012RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: ibandronate sodium

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche
BONIVA
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 20064,927,814<disabled>
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-002Mar 24, 20054,927,814<disabled>
Roche
BONIVA
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 20065,662,918<disabled>
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International Patent Family for Ingredient: ibandronate sodium

Country Document Number Publication Date
Israel164371Nov 30, 2010
Colombia5050325Jun 27, 2001
Malaysia140080Nov 30, 2009
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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