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Serving leading biopharmaceutical companies globally:

Harvard Business School
Teva
US Army
Merck
Chubb
Deloitte
Queensland Health
Accenture
Argus Health
Covington

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021858

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NDA 021858 describes BONIVA, which is a drug marketed by Roche and Hoffmann La Roche and is included in two NDAs. It is available from two suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the BONIVA profile page.

The generic ingredient in BONIVA is ibandronate sodium. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.
Summary for 021858
Tradename:BONIVA
Applicant:Roche
Ingredient:ibandronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021858
Ingredient-typeDiphosphonates
Suppliers and Packaging for NDA: 021858
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858 NDA Genentech, Inc. 0004-0191 N 0004-0191-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 3MG BASE/3ML
Approval Date:Jan 6, 2006TE:APRLD:Yes

Expired US Patents for NDA 021858

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Chubb
Cipla
Merck
Deloitte
QuintilesIMS
Boehringer Ingelheim
AstraZeneca

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