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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 |
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