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
(2 years ago) |
Expired
|
| US7410957 | Method of treatment using bisphosphonic acid |
May, 2023
(2 years ago) |
Expired
|
| US7718634 | Method of treatment using bisphosphonic acid |
May, 2023
(2 years ago) |
Expired
|
| US6294196 | Pharmaceutical composition containing diphosphonic acid or salt thereof |
Oct, 2019
(6 years ago) |
Expired
|
| US6143326 | Oral pharmaceutical preparation containing ibandronat |
Apr, 2017
(8 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.
Latest 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 |
|---|---|---|
 | ||
| Expire Patent
Critical | 22 Apr, 2019 | US7192938 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 05 Nov, 2018 | US7192938 (Litigated) |
| Expire Patent
Critical | 18 Jun, 2018 | US7718634 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 01 Jan, 2018 | US7718634 (Litigated) |
| Expire Patent
Critical | 09 Sep, 2016 | US7410957 (Litigated) |
| Recordation of Patent Grant Mailed
Critical | 18 May, 2010 | US7718634 (Litigated) |
| Patent Issue Date Used in PTA Calculation
Critical | 18 May, 2010 | US7718634 (Litigated) |
| Issue Notification Mailed
Critical | 28 Apr, 2010 | US7718634 (Litigated) |
| Dispatch to FDC | 14 Apr, 2010 | US7718634 (Litigated) |
| Application Is Considered Ready for Issue
Critical | 14 Apr, 2010 | US7718634 (Litigated) |
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 |
|---|---|---|---|
 | |||
| 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 Farmacêutica, 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
Explore Our Curated Drug Screens
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 Generic API suppliers:
Ibandronate Sodium is the generic name for the brand Boniva. 15 different companies have already filed for the generic of Boniva, with Pharmobedient 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 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
(11 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.
Latest 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 |
|---|---|---|
| | ||
| Expire Patent
Critical | 22 Apr, 2019 | US7192938 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 05 Nov, 2018 | US7192938 (Litigated) |
| Expire Patent
Critical | 18 Jun, 2018 | US7718634 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 01 Jan, 2018 | US7718634 (Litigated) |
| Expire Patent
Critical | 09 Sep, 2016 | US7410957 (Litigated) |
| Recordation of Patent Grant Mailed
Critical | 18 May, 2010 | US7718634 (Litigated) |
| Patent Issue Date Used in PTA Calculation
Critical | 18 May, 2010 | US7718634 (Litigated) |
| Issue Notification Mailed
Critical | 28 Apr, 2010 | US7718634 (Litigated) |
| Dispatch to FDC | 14 Apr, 2010 | US7718634 (Litigated) |
| Application Is Considered Ready for Issue
Critical | 14 Apr, 2010 | US7718634 (Litigated) |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
Ibandronate Sodium is the generic name for the brand Boniva. 15 different companies have already filed for the generic of Boniva, with Pharmobedient 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 |