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Details for Generic Name: ibandronate sodium

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

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

Drug Master File Entries: see list16
Suppliers: see list2
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ibandronate sodium

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

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

Study Comparing Ibandronate Versus Placebo in Hip Osteonecrosis
Status: Not yet recruiting Condition: Aseptic;; Hip Necrosis

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

Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
Status: Completed Condition: Postmenopausal Osteoporosis

PTH & Ibandronate Combination Study (PICS)
Status: Completed Condition: Osteoporosis

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
ibandronate sodium
TABLET; ORAL021455-002Mar 24, 2005RXYes4,927,814<disabled><disabled>
ibandronate sodium
INJECTABLE; INTRAVENOUS021858-001Jan 6, 2006RXYes5,662,918<disabled><disabled>
ibandronate sodium
TABLET; ORAL021455-001May 16, 2003RXYes6,143,326<disabled><disabled>
ibandronate sodium
TABLET; ORAL021455-002Mar 24, 2005RXYes<disabled><disabled>
ibandronate sodium
INJECTABLE; INTRAVENOUS021858-001Jan 6, 2006RXYes4,927,814<disabled><disabled>
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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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