INDIGOTINDISULFONATE SODIUM - Generic Drug Details

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What are the generic drug sources for indigotindisulfonate sodium and what is the scope of freedom to operate?

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:	5
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Prove pharm	Phase 4
University of Massachusetts, Worcester	Phase 3
Columbia University	Phase 4

See all INDIGOTINDISULFONATE SODIUM clinical trials

Pharmacology for INDIGOTINDISULFONATE SODIUM

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

US Patents and Regulatory Information for INDIGOTINDISULFONATE SODIUM

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Glossary

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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	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
>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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2018116325		⤷ Sign Up
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))	⤷ Sign Up
>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.

Summary for INDIGOTINDISULFONATE SODIUM

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INDIGOTINDISULFONATE SODIUM

Recent Clinical Trials for INDIGOTINDISULFONATE SODIUM

Pharmacology for INDIGOTINDISULFONATE SODIUM

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INDIGOTINDISULFONATE SODIUM