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Last Updated: March 28, 2024

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INDIGOTINDISULFONATE SODIUM - Generic Drug Details


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What are the generic sources for indigotindisulfonate sodium and what is the scope of patent protection?

Indigotindisulfonate sodium is the generic ingredient in one branded drug marketed by Provepharm Sas and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Indigotindisulfonate sodium has two patent family members in two countries.

There are two drug master file entries for indigotindisulfonate sodium. One supplier is listed for this compound.

Summary for INDIGOTINDISULFONATE SODIUM
International Patents:2
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 109
Clinical Trials: 3
Patent Applications: 3,725
What excipients (inactive ingredients) are in INDIGOTINDISULFONATE SODIUM?INDIGOTINDISULFONATE SODIUM excipients list
DailyMed Link:INDIGOTINDISULFONATE SODIUM at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INDIGOTINDISULFONATE SODIUM
Generic Entry Date for INDIGOTINDISULFONATE SODIUM*:
Constraining patent/regulatory exclusivity:
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 INDIGOTINDISULFONATE SODIUM

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

SponsorPhase
University of Massachusetts, WorcesterPhase 3
Columbia UniversityPhase 4
Weill Medical College of Cornell UniversityPhase 1/Phase 2

See all INDIGOTINDISULFONATE SODIUM clinical trials

Pharmacology for INDIGOTINDISULFONATE SODIUM
Drug ClassDiagnostic Dye
Mechanism of ActionDyes

US Patents and Regulatory Information for INDIGOTINDISULFONATE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Provepharm Sas BLUDIGO indigotindisulfonate sodium SOLUTION;INTRAVENOUS 216264-001 Jul 8, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Provepharm Sas BLUDIGO indigotindisulfonate sodium SOLUTION;INTRAVENOUS 216264-001 Jul 8, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Provepharm Sas BLUDIGO indigotindisulfonate sodium SOLUTION;INTRAVENOUS 216264-001 Jul 8, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Provepharm Sas BLUDIGO indigotindisulfonate sodium SOLUTION;INTRAVENOUS 216264-001 Jul 8, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

International Patents for INDIGOTINDISULFONATE SODIUM

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2018116325 ⤷  Try a Trial
European Patent Office 3559121 NOUVEAU PROCÉDÉ POUR LA PRÉPARATION D'INDIGOTINDISULFONATE DE SODIUM (CARMIN D'INDIGO) (NOVEL PROCESS FOR THE PREPARATION OF INDIGOTINDISULFONATE SODIUM (INDIGO CARMINE)) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.