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Ibandronate sodium - Generic Drug Details
What are the generic drug sources for ibandronate sodium and what is the scope of freedom to operate?
Ibandronate sodium
is the generic ingredient in two branded drugs marketed by Roche, Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Mylan Labs Ltd, Sagent Pharms Inc, Sun Pharm, Hoffmann La Roche, Apotex Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Sun Pharm Industries, and Watson Labs Teva, and is included in seventeen NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Ibandronate sodium has seventy-one patent family members in thirty-two countries.
There are sixteen drug master file entries for ibandronate sodium. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for ibandronate sodium
| International Patents: | 71 |
| US Patents: | 3 |
| Tradenames: | 2 |
| Applicants: | 16 |
| NDAs: | 17 |
| Drug Master File Entries: | 16 |
| Suppliers / Packagers: | 11 |
| Bulk Api Vendors: | 43 |
| Clinical Trials: | 4 |
| Patent Applications: | 13 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for ibandronate sodium |
| DailyMed Link: | ibandronate sodium at DailyMed |
Recent Clinical Trials for ibandronate sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dr. Reddy's Laboratories Limited | Phase 1 |
| National Cancer Institute (NCI) | Phase 3 |
| Southwest Oncology Group | Phase 3 |
Generic filers with tentative approvals for IBANDRONATE SODIUM
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 2.5MG | TABLET; ORAL |
| Start Trial | Start Trial | 1MG | INJECTABLE; INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for ibandronate sodium
| Drug Class | Bisphosphonate |
Paragraph IV (Patent) Challenges for IBANDRONATE SODIUM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BONIVA | INJECTABLE;INTRAVENOUS | ibandronate sodium | 021858 | 2007-08-31 |
| BONIVA | TABLET;ORAL | ibandronate sodium | 021455 | 2007-05-16 |
US Patents and Regulatory Information for ibandronate sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 206058-001 | Feb 5, 2016 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Emcure Pharms Ltd | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 203987-001 | Sep 2, 2014 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Orchid Hlthcare | IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 078998-001 | Mar 19, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start 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 ibandronate sodium
| 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 | Start Trial | Start Trial |
| Roche | BONIVA | ibandronate sodium | INJECTABLE;INTRAVENOUS | 021858-001 | Jan 6, 2006 | 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 |
International Patents for ibandronate sodium
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Argentina | 061845 | Start Trial |
| Israel | 164371 | Start Trial |
| Japan | 5813911 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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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