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:

Mallinckrodt
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Last Updated: November 16, 2019

DrugPatentWatch Database Preview

DOTAREM Drug Profile

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When do Dotarem patents expire, and when can generic versions of Dotarem launch?

Dotarem is a drug marketed by Guerbet and is included in one NDA.

The generic ingredient in DOTAREM is gadoterate meglumine. One supplier is listed for this compound. Additional details are available on the gadoterate meglumine profile page.

Drug patent expirations by year for DOTAREM
Drug Prices for DOTAREM

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Generic Entry Opportunity Date for DOTAREM
Generic Entry Date for DOTAREM*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
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 DOTAREM

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

SponsorPhase
Boston Medical CenterPhase 4
Massachusetts General HospitalPhase 4
GuerbetN/A

See all DOTAREM clinical trials

Pharmacology for DOTAREM

US Patents and Regulatory Information for DOTAREM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Guerbet DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781-005 Mar 31, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Guerbet DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781-004 Mar 20, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Guerbet DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781-002 Mar 20, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Guerbet DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781-003 Mar 20, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Guerbet DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781-001 Mar 20, 2013 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

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Express Scripts
AstraZeneca
Colorcon
Baxter

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 verifification 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.