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Generated: July 23, 2017
What are the generic drug sources for ibandronate sodium and what is the scope of ibandronate sodium patent protection?
Ibandronate sodium is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Watson Labs Teva, Apotex Inc, Sagent Pharms, Sun Pharm Inds Ltd, Hoffmann La Roche, Roche, Accord Hlthcare, Mylan Labs Ltd, Emcure Pharms Ltd, Mylan Pharms Inc, Sun Pharm Inds, Dr Reddys Labs Ltd, and Orchid Hlthcare, and is included in sixteen NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 6 |
| Applicants: | 14 |
| NDAs: | 16 |
| Drug Master File Entries: see list | 16 |
| Suppliers / Packagers: see list | 14 |
| Bulk Api Vendors: see list | 129 |
| Clinical Trials: see list | 2,427 |
| Patent Applications: see list | 5,839 |
| Therapeutic Class: | Metabolic Bone Disease Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | ibandronate sodium at DailyMed |
| Ingredient-type | Diphosphonates |
| Drug Class | Bisphosphonate |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 2.5MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 1MG | INJECTABLE; INJECTION |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-002 | Mar 24, 2005 | AB | RX | Yes | Yes | 7,192,938 | ► Subscribe | ► Subscribe | |||||||||||||||||
Sun Pharm Inds | IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 078996-001 | Aug 15, 2012 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sun Pharm Inds Ltd | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 090853-001 | Feb 14, 2014 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sagent Pharms | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 202235-001 | Sep 2, 2014 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Orchid Hlthcare | IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 078998-001 | Mar 19, 2012 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| 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 | 4,927,814 | ► Subscribe | ||||||||||||||||||||||
Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-001 | May 16, 2003 | 4,927,814 | ► Subscribe | ||||||||||||||||||||||
Roche | BONIVA | ibandronate sodium | INJECTABLE;INTRAVENOUS | 021858-001 | Jan 6, 2006 | 5,662,918 | ► Subscribe | ||||||||||||||||||||||
Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-001 | May 16, 2003 | 6,143,326 | ► Subscribe | ||||||||||||||||||||||
Roche | BONIVA | ibandronate sodium | INJECTABLE;INTRAVENOUS | 021858-001 | Jan 6, 2006 | 4,927,814 | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,627,221 | Pharmaceutical composition containing diphosphonic acid or salt thereof | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 5813911 | ► Subscribe | |||||||||||||||||||||||||||
| Argentina | 039978 | ► Subscribe | |||||||||||||||||||||||||||
| Czech Republic | 9803364 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2013166773 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5557989 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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