GADAVIST Drug Patent Profile
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When do Gadavist patents expire, and when can generic versions of Gadavist launch?
Gadavist is a drug marketed by Bayer Hlthcare and is included in one NDA.
The generic ingredient in GADAVIST is gadobutrol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the gadobutrol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gadavist
A generic version of GADAVIST was approved as gadobutrol by HENGRUI PHARMA on November 17th, 2022.
Summary for GADAVIST
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 5 |
| Clinical Trials: | 28 |
| Patent Applications: | 516 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GADAVIST |
| What excipients (inactive ingredients) are in GADAVIST? | GADAVIST excipients list |
| DailyMed Link: | GADAVIST at DailyMed |
Recent Clinical Trials for GADAVIST
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institutes of Health (NIH) | Early Phase 1 |
| Lipella Pharmaceuticals, Inc. | Early Phase 1 |
| Christopher J Chermansky, MD | Early Phase 1 |
Pharmacology for GADAVIST
| Drug Class | Gadolinium-based Contrast Agent |
| Mechanism of Action | Magnetic Resonance Contrast Activity |
Anatomical Therapeutic Chemical (ATC) Classes for GADAVIST
US Patents and Regulatory Information for GADAVIST
| 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 | 201277-006 | Dec 18, 2013 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-003 | Mar 14, 2011 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-001 | Mar 14, 2011 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-002 | Mar 14, 2011 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-005 | Mar 14, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 GADAVIST
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-004 | Mar 14, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-006 | Dec 18, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-003 | Mar 14, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-002 | Mar 14, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-001 | Mar 14, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GADAVIST
See the table below for patents covering GADAVIST around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2074219 | ⤷ Try a Trial | |
| Japan | 2968367 | ⤷ Try a Trial | |
| Hungary | T60478 | ⤷ Try a Trial | |
| New Zealand | 237461 | 10-TRIHYDROXYBUTYL-1,4, | ⤷ Try a Trial |
| Israel | 97592 | Tetraazacyclododecane butyltriol derivatives processes for the production thereof and pharmaceutical compositions containing the same | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GADAVIST
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0448191 | CA 2001 00009 | Denmark | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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