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Last Updated: July 7, 2020

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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 three 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. Eleven 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:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 021455
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 0004-0186-83 1 BLISTER PACK in 1 BOX (0004-0186-83) > 3 TABLET, FILM COATED in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021455
Tradename Dosage Ingredient NDA Submissiondate
BONIVA TABLET;ORAL ibandronate sodium 021455 2007-05-16

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2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 24, 2005TE:ABRLD:Yes
Patent:  Start 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
Patent:  Start TrialPatent Expiration:May 6, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT AND PREVENTION OF OSTEOPOROSIS

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

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