Gadobutrol - Generic Drug Details
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What are the generic drug sources for gadobutrol and what is the scope of patent protection?
Gadobutrol
is the generic ingredient in two branded drugs marketed by Bayer Hlthcare, Hainan Poly Pharm, and Hengrui Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for gadobutrol. Three suppliers are listed for this compound.
Summary for gadobutrol
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 42 |
| Patent Applications: | 401 |
| 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 |
|---|---|
| Christopher J Chermansky, MD | Early Phase 1 |
| National Institutes of Health (NIH) | Early Phase 1 |
| Lipella Pharmaceuticals, Inc. | Early Phase 1 |
Pharmacology for gadobutrol
| Drug Class | Gadolinium-based Contrast Agent |
| Mechanism of Action | Magnetic Resonance Contrast Activity |
Anatomical Therapeutic Chemical (ATC) Classes for gadobutrol
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hengrui Pharma | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 216081-006 | Nov 17, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-003 | Mar 14, 2011 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-001 | Mar 14, 2011 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-005 | Mar 14, 2011 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hengrui Pharma | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 216081-004 | Nov 17, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hengrui Pharma | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 216081-003 | Nov 17, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | 201277-006 | Dec 18, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-003 | Mar 14, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-004 | Mar 14, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-005 | Mar 14, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-002 | Mar 14, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-001 | Mar 14, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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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