Boniva Patent Expiration

Boniva is a drug owned by Hoffmann La Roche Inc. It is protected by 5 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 06, 2023. Details of Boniva's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7192938 Method of treatment using bisphosphonic acid
May, 2023

(1 year, 5 months ago)

Expired
US7410957 Method of treatment using bisphosphonic acid
May, 2023

(1 year, 5 months ago)

Expired
US7718634 Method of treatment using bisphosphonic acid
May, 2023

(1 year, 5 months ago)

Expired
US6294196 Pharmaceutical composition containing diphosphonic acid or salt thereof
Oct, 2019

(5 years ago)

Expired
US6143326 Oral pharmaceutical preparation containing ibandronat
Apr, 2017

(7 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Boniva's patents.

Given below is the list of recent legal activities going on the following patents of Boniva.

Activity Date Patent Number
Patent litigations
Expire Patent 22 Apr, 2019 US7192938 (Litigated)
Maintenance Fee Reminder Mailed 05 Nov, 2018 US7192938 (Litigated)
Expire Patent 18 Jun, 2018 US7718634 (Litigated)
Maintenance Fee Reminder Mailed 01 Jan, 2018 US7718634 (Litigated)
Expire Patent 09 Sep, 2016 US7410957 (Litigated)
Recordation of Patent Grant Mailed 18 May, 2010 US7718634 (Litigated)
Patent Issue Date Used in PTA Calculation 18 May, 2010 US7718634 (Litigated)
Issue Notification Mailed 28 Apr, 2010 US7718634 (Litigated)
Dispatch to FDC 14 Apr, 2010 US7718634 (Litigated)
Application Is Considered Ready for Issue 14 Apr, 2010 US7718634 (Litigated)

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

Several oppositions have been filed on Boniva's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Boniva's generic, the next section provides detailed information on ongoing and past EP oppositions related to Boniva patents.

Boniva's Oppositions Filed in EPO

Boniva has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 29, 2008, by Ratiopharm Gmbh. This opposition was filed on patent number EP03722591A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP07014362A Jun, 2018 ALIUD PHARMA GmbH / STADA Arzneimittel GmbH Revoked
EP07014362A Oct, 2015 Hexal AG Revoked
EP07014362A Oct, 2015 Gedeon Richter Plc. Revoked
EP07014362A Oct, 2015 Actavis Group PTC EHF Revoked
EP07014362A Oct, 2015 Generica Ilac Sanayi ve Ticaret A.S. Revoked
EP07014362A Jun, 2015 Agrobiogen GmbH Biotechnologie Revoked
EP07014362A Feb, 2015 Laboratorios Liconsa, S.A. Revoked
EP07014362A Jan, 2015 Synthon BV Revoked
EP07014362A Jan, 2015 Avansor Pharma Oy Revoked
EP07014362A Jan, 2015 G. L. Pharma GmbH Revoked
EP07014362A Jan, 2015 Glenmark Pharmaceuticals s.r.o. Revoked
EP07014362A Jan, 2015 Stada-Arzneimittel Aktiengesellschaft Revoked
EP03722591A Feb, 2011 Sandoz FarmacĂȘutica, Lda. Revoked
EP03722591A Jul, 2008 Gedeon Richter Plc. Revoked
EP03722591A Jul, 2008 PLIVA HRVATSKA d.o.o. Revoked
EP03722591A Jul, 2008 Generics [UK] Limited Revoked
EP03722591A Jul, 2008 Synthon BV Revoked
EP03722591A Jul, 2008 Teva Pharmaceutical Industries Ltd. et al. Revoked
EP03722591A Jul, 2008 ALFRED, E. TIEFENBACHER GMBH & CO. KG Revoked
EP03722591A Jul, 2008 Laboratorios Liconsa, S.A. Revoked
EP03722591A May, 2008 Ratiopharm GmbH Revoked


US patents provide insights into the exclusivity only within the United States, but Boniva is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Boniva's family patents as well as insights into ongoing legal events on those patents.

Boniva's Family Patents

Boniva has patent protection in a total of 32 countries. It's US patent count contributes only to 7.5% of its total global patent coverage. 20 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Boniva.

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Boniva's generic launch date based on the expiry of its last outstanding patent is estimated to be May 06, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Boniva Generics:

Ibandronate Sodium is the generic name for the brand Boniva. 16 different companies have already filed for the generic of Boniva, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Boniva's generic

How can I launch a generic of Boniva before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Boniva's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Boniva's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Boniva -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
1 mg/mL, 3 mL Vial 31 Aug, 2007 1 02 Sep, 2014 Extinguished
150 mg 16 May, 2007 8 19 Mar, 2012 06 May, 2023 Deferred
2.5 mg 16 May, 2007 1 06 May, 2023 Extinguished





About Boniva

Boniva is a drug owned by Hoffmann La Roche Inc. It is used for the treatment and prevention of osteoporosis in postmenopausal women. Boniva uses Ibandronate Sodium as an active ingredient. Boniva was launched by Hoffmann La Roche in 2003.

Approval Date:

Boniva was approved by FDA for market use on 16 May, 2003.

Active Ingredient:

Boniva uses Ibandronate Sodium as the active ingredient. Check out other Drugs and Companies using Ibandronate Sodium ingredient

Treatment:

Boniva is used for the treatment and prevention of osteoporosis in postmenopausal women.

Dosage:

Boniva is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL


Boniva Patent Expiration

Boniva is a drug owned by Hoffmann La Roche Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 02, 2014. Details of Boniva's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5662918 Pharmaceutical agents containing diphosphonic acids and salts thereof
Sep, 2014

(10 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Boniva's patents.

Given below is the list of recent legal activities going on the following patents of Boniva.

Activity Date Patent Number
Patent litigations
Expire Patent 22 Apr, 2019 US7192938 (Litigated)
Maintenance Fee Reminder Mailed 05 Nov, 2018 US7192938 (Litigated)
Expire Patent 18 Jun, 2018 US7718634 (Litigated)
Maintenance Fee Reminder Mailed 01 Jan, 2018 US7718634 (Litigated)
Expire Patent 09 Sep, 2016 US7410957 (Litigated)
Recordation of Patent Grant Mailed 18 May, 2010 US7718634 (Litigated)
Patent Issue Date Used in PTA Calculation 18 May, 2010 US7718634 (Litigated)
Issue Notification Mailed 28 Apr, 2010 US7718634 (Litigated)
Dispatch to FDC 14 Apr, 2010 US7718634 (Litigated)
Application Is Considered Ready for Issue 14 Apr, 2010 US7718634 (Litigated)

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Boniva is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Boniva's family patents as well as insights into ongoing legal events on those patents.

Boniva's Family Patents


Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Boniva's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 02, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Boniva Generics:

Ibandronate Sodium is the generic name for the brand Boniva. 16 different companies have already filed for the generic of Boniva, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Boniva's generic

How can I launch a generic of Boniva before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Boniva's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Boniva's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Boniva -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
1 mg/mL, 3 mL Vial 31 Aug, 2007 1 02 Sep, 2014 Extinguished
150 mg 16 May, 2007 8 19 Mar, 2012 06 May, 2023 Deferred
2.5 mg 16 May, 2007 1 06 May, 2023 Extinguished





About Boniva

Boniva is a drug owned by Hoffmann La Roche Inc. It is used for the treatment and prevention of osteoporosis in postmenopausal women. Boniva uses Ibandronate Sodium as an active ingredient. Boniva was launched by Roche in 2006.

Approval Date:

Boniva was approved by FDA for market use on 06 January, 2006.

Active Ingredient:

Boniva uses Ibandronate Sodium as the active ingredient. Check out other Drugs and Companies using Ibandronate Sodium ingredient

Treatment:

Boniva is used for the treatment and prevention of osteoporosis in postmenopausal women.

Dosage:

Boniva is available in injectable form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE Discontinued INTRAVENOUS