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Generated: November 13, 2018

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Details for New Drug Application (NDA): 021455

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NDA 021455 describes BONIVA, which is a drug marketed by Roche and Hoffmann La Roche and is included in two NDAs. It is available from one supplier. 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. Thirteen suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.
Summary for 021455
Tradename:BONIVA
Applicant:Hoffmann La Roche
Ingredient:ibandronate sodium
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 021455
Ingredient-typeDiphosphonates
Suppliers and Packaging for NDA: 021455
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BONIVA ibandronate sodium TABLET;ORAL 021455 NDA Genentech, Inc. 0004-0186 0004-0186-82 3 BLISTER PACK in 1 BOX (0004-0186-82) > 1 TABLET, FILM COATED in 1 BLISTER PACK
BONIVA ibandronate sodium TABLET;ORAL 021455 NDA Genentech, Inc. 0004-0186 0004-0186-83 1 BLISTER PACK in 1 BOX (0004-0186-83) > 3 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 16, 2003TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 7, 2019Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 24, 2005TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 7, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:May 6, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN BY ONCE-MONTHLY ORAL ADMINISTRATION OF IBANDRONATE SODIUM MONOHYDRATE EQUIVALENT TO 150MG OF IBANDRONIC ACID

Expired US Patents for NDA 021455

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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