BONIVA Drug Patent Profile
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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. There are three patents protecting this drug and two Paragraph IV challenges.
This drug has seventy-one patent family members in thirty-two countries.
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.
Summary for BONIVA
| International Patents: | 71 |
| US Patents: | 3 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 84 |
| Clinical Trials: | 13 |
| Patent Applications: | 4,367 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BONIVA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BONIVA |
| What excipients (inactive ingredients) are in BONIVA? | BONIVA excipients list |
| DailyMed Link: | BONIVA at DailyMed |
Recent Clinical Trials for BONIVA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hoffmann-La Roche | Phase 3 |
| Hoffmann-La Roche | |
| M.D. Anderson Cancer Center | Phase 3 |
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
BONIVA is protected by three US patents.
Patents protecting BONIVA
Method of treatment using bisphosphonic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Method of treatment using bisphosphonic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT AND PREVENTION OF OSTEOPOROSIS
Method of treatment using bisphosphonic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT AND PREVENTION OF OSTEOPOROSIS
| 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 | 021455-002 | Mar 24, 2005 | 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 |
| 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 |
| Roche | BONIVA | ibandronate sodium | INJECTABLE;INTRAVENOUS | 021858-001 | Jan 6, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Premature patent expiration for: BONIVA
Expiration due to failure to pay maintenance fee
| Patent Number | Tradename | Expiration Date |
|---|---|---|
| ⤷ Try a Trial | BONIVA | ⤷ Try a Trial |
International Patents for BONIVA
See the table below for patents covering BONIVA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Croatia | P20040906 | BISPHOSPHONIC ACID FOR THE TREATMENT AND PREVENTION OF OSTREOPOROSIS | ⤷ Try a Trial |
| German Democratic Republic | 263992 | NEUE DIPHOSPHONSAEUREDERIVATE, VERFAHREN ZU DEREN HERSTELLUNG UND DIESE VERBINDUNGEN ENTHALTENDE ARZNEIMITTEL | ⤷ Try a Trial |
| Greece | 3023962 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 03095029 | ⤷ 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 | 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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.
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