You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

BONIVA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Boniva, and what generic alternatives are available?

Boniva is a drug marketed by Roche and Hoffmann La Roche and is included in two NDAs.

The generic ingredient in BONIVA is ibandronate sodium. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Boniva

A generic version of BONIVA was approved as ibandronate sodium by APOTEX INC on March 19th, 2012.

  Try a Trial

Drug patent expirations by year for BONIVA
Drug Prices for BONIVA

See drug prices for BONIVA

Drug Sales Revenue Trends for BONIVA

See drug sales revenues for BONIVA

Recent Clinical Trials for BONIVA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hoffmann-La RochePhase 3
Hoffmann-La Roche
Roche Pharma AGPhase 3

See all BONIVA clinical trials

Paragraph IV (Patent) Challenges for BONIVA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BONIVA Injection ibandronate sodium 1 mg/mL, 3 mL Vial 021858 1 2007-08-31
BONIVA Tablets ibandronate sodium 2.5 mg 021455 1 2007-05-16

US Patents and Regulatory Information for BONIVA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BONIVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 ⤷  Try a Trial ⤷  Try a Trial
Roche BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858-001 Jan 6, 2006 ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-002 Mar 24, 2005 ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche BONIVA ibandronate sodium TABLET;ORAL 021455-001 May 16, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BONIVA

See the table below for patents covering BONIVA around the world.

Country Patent Number Title Estimated Expiration
New Zealand 221027 DIPHOSPHONIC ACID DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS ⤷  Try a Trial
Germany 19615812 ⤷  Try a Trial
Ecuador SP045335 ACIDOS BISFOSFONICOS PARA EL TRATAMIENTO Y PREVENCION DE OSTEOPOROSIS ⤷  Try a Trial
South Korea 20000010557 ⤷  Try a Trial
European Patent Office 0936913 PREPARATION PHARMACEUTIQUE ORALE CONTENANT DE L'IBANDRONATE (ORAL PHARMACEUTICAL PREPARATION CONTAINING IBANDRONAT) ⤷  Try a Trial
Portugal 1506041 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BONIVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0252504 96C0046 Belgium ⤷  Try a Trial PRODUCT NAME: DOXORUBICIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/96/011/001 19960624
0252504 SPC/GB96/060 United Kingdom ⤷  Try a Trial PRODUCT NAME: IBANDRONIC ACID ((1-HYDROXY-3-(METHYLPENTYLAMINO) - PROPYLIDINE)-DIPHOSPHONIC ACID); REGISTERED: UK EU/1/96/012/001 19960625
0252504 C960032 Netherlands ⤷  Try a Trial PRODUCT NAME: ACIDUM IBANDRONICUM, DESGEWENST IN DE VORM VAN EEN FARMACOLO- GISCH AANVAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET METHANOL,ETHANOL,2-PROPANOL OF 2-METHYLPROPANOL, OF IN DE VORM VEN EEN HYDRAAT,I.H.B.MONONATRIUM IBANDRONAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/96/012/001 19960625
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.