GADAVIST Drug Patent Profile
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Which patents cover Gadavist, 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. Three 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: | 30 |
Clinical Trials: | 28 |
Patent Applications: | 410 |
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 |
![GADAVIST drug patent expirations Drug patent expirations by year for GADAVIST](/p/graph/s/t/GADAVIST-patent-expirations.png)
![Drug Prices for GADAVIST](/p/graph/drug-price/GADAVIST.png)
Recent Clinical Trials for GADAVIST
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 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 | ⤷ 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 | |||
>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 | 201277-003 | 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 | 201277-006 | Dec 18, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Hong Kong | 1002811 | ⤷ Sign Up | |
Norway | 911063 | ⤷ Sign Up | |
Hungary | 215964 | Eljárás 1,4,7,10-tetraazaciklododekán-butil-triolát-származékok előállítására, eljárás ezeket a vegyületeket tartalmazó gyógyszerkészítmények előállítására, és ezeket a vegyületeket tartalmazó diagnosztikai készítmények (PROCESS FOR PRODUCING 1,4,7,10-TETRAAZACYCLODODECANE-BUTYLTRIOLATE DERIVATIVES,PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME AND DIAGNOSTIC AGENTS CONTAINING THE COMPOUNDS) | ⤷ Sign Up |
>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 | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |