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BLUDIGO Drug Patent Profile

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

Bludigo is a drug marketed by Provepharm Sas and is included in one NDA. There are three patents protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in BLUDIGO is indigotindisulfonate sodium. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the indigotindisulfonate sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Bludigo

Bludigo will be eligible for patent challenges on July 8, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 23, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for BLUDIGO

International Patents:	2
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	2
Patent Applications:	4,114
Drug Prices:	Drug price information for BLUDIGO
What excipients (inactive ingredients) are in BLUDIGO?	BLUDIGO excipients list
DailyMed Link:	BLUDIGO at DailyMed

Drug patent expirations by year for BLUDIGO

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

Generic Entry Date for BLUDIGO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 216264 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 BLUDIGO

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

Sponsor	Phase
Prove pharm	Phase 4

See all BLUDIGO clinical trials

Pharmacology for BLUDIGO

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

US Patents and Regulatory Information for BLUDIGO

BLUDIGO is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BLUDIGO is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BLUDIGO

Process for the preparation of Indigotindisulfonate sodium (indigo carmine)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting BLUDIGO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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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				⤷ 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 BLUDIGO

When does loss-of-exclusivity occur for BLUDIGO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Patent: 59121
Patent: NOUVEAU PROCÉDÉ POUR LA PRÉPARATION D'INDIGOTINDISULFONATE DE SODIUM (CARMIN D'INDIGO) (NOVEL PROCESS FOR THE PREPARATION OF INDIGOTINDISULFONATE SODIUM (INDIGO CARMINE))
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BLUDIGO around the world.

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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