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Gadobutrol - Generic Drug Details
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What are the generic sources for gadobutrol and what is the scope of patent protection?
Gadobutrol
is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Gadobutrol has twenty-five patent family members in sixteen countries.
There is one drug master file entry for gadobutrol. One supplier is listed for this compound.
Summary for gadobutrol
| International Patents: | 25 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 37 |
| Clinical Trials: | 37 |
| Patent Applications: | 1,133 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in gadobutrol? | gadobutrol excipients list |
| DailyMed Link: | gadobutrol at DailyMed |
Recent Clinical Trials for gadobutrol
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bayer AG (Sponsor) | Phase 4 |
| IQVIA (Sponsor) | Phase 4 |
| Bracco (Sponsor) | Phase 4 |
Pharmacology for gadobutrol
| Drug Class | Gadolinium-based Contrast Agent |
| Mechanism of Action | Magnetic Resonance Contrast Activity |
US Patents and Regulatory Information for gadobutrol
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-004 | Mar 14, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-003 | Mar 14, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-005 | Mar 14, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-006 | Dec 18, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-006 | Dec 18, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-002 | Mar 14, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-001 | Mar 14, 2011 | RX | Yes | Yes | 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 gadobutrol
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-001 | Mar 14, 2011 | Start Trial | Start Trial |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-005 | Mar 14, 2011 | Start Trial | Start Trial |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-004 | Mar 14, 2011 | Start Trial | Start Trial |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-002 | Mar 14, 2011 | Start Trial | Start Trial |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-003 | Mar 14, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for gadobutrol
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 237461 | Start Trial |
| Germany | 10075007 | Start Trial |
| Germany | 4009119 | Start Trial |
| Hungary | 910874 | Start Trial |
| Finland | 109695 | Start Trial |
| Germany | 59105815 | Start Trial |
| Australia | 647091 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for gadobutrol
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0448191 | CA 2001 00009 | Denmark | Start Trial | |
| >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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