Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Last Updated: October 16, 2019

DrugPatentWatch Database Preview

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.

Drug patent expirations by year for GADAVIST
Drug Prices for GADAVIST

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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
Boston Medical CenterPhase 4
Cedars-Sinai Medical CenterN/A
University of Texas Southwestern Medical CenterEarly Phase 1

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   See Pricing   See Pricing Y Y   See Pricing
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-004 Mar 14, 2011 RX Yes Yes   See Pricing   See Pricing   See Pricing
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-002 Mar 14, 2011 RX Yes Yes   See Pricing   See Pricing   See Pricing
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-005 Mar 14, 2011 RX Yes Yes   See Pricing   See Pricing   See Pricing
>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   See Pricing   See Pricing
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-001 Mar 14, 2011   See Pricing   See Pricing
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-003 Mar 14, 2011   See Pricing   See Pricing
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-005 Mar 14, 2011   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Dow
Baxter
Colorcon
Boehringer Ingelheim

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