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Last Updated: January 20, 2020

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GADAVIST Drug Profile

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When do Gadavist patents expire, and what generic alternatives are available?

Gadavist is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-five patent family members in sixteen countries.

The generic ingredient in GADAVIST is gadobutrol. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadobutrol profile page.

US ANDA Litigation and Generic Entry Outlook for Gadavist

  Start Trial

Gadavist was eligible for patent challenges on March 14th, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 12th, 2022. This may change due to patent challenges or generic licensing.

Drug patent expirations by year for GADAVIST
Drug Prices for GADAVIST

See drug prices for GADAVIST

Generic Entry Opportunity Date for GADAVIST
Generic Entry Date for GADAVIST*:
Constraining patent/regulatory exclusivity:
USE IN CARDIAC MRI TO ASSESS MYOCARDIAL PERFUSION (STRESS, REST) AND LATE GADOLINIUM ENHANCEMENT IN ADULT PATIENTS WITH KNOWN OR SUSPECTED CORONARY ARTERY DISEASE (CAD)
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GADAVIST

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Institute (NCI)Early Phase 1
M.D. Anderson Cancer CenterEarly Phase 1
Boston Medical CenterPhase 4

See all GADAVIST clinical trials

Pharmacology for GADAVIST
Synonyms for GADAVIST
10-((1RS,2SR)-2,3-Dihydroxy-1-(hydroxymethyl)propyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triacetato(3-))gadolinium
138071-82-6
CS-2214
Gadobutrol
Gadobutrol [USAN:INN:JAN]
Gadograf
Gadolinium-DO3A-butriol
Gadolinium, (10-(2,3-Dihydroxy-1-(hydroxymethyl)propyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triacetato(3-)-N1,N4,N7,N10,O1,O4,O7)-
Gadovist
Gd-DO3A-butriol
HSDB 8231
HY-16217
Protovist
ZK 135079

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 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
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 201277-002 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
>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 201277-001 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 201277-005 Mar 14, 2011   Start Trial   Start Trial
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-002 Mar 14, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Dow
Boehringer Ingelheim
Johnson and Johnson
AstraZeneca

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