Details for New Drug Application (NDA): 216264

NDA 216264 describes BLUDIGO, which is a drug marketed by Provepharm Sas and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the BLUDIGO profile page.

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.

Summary for 216264

Tradename:	BLUDIGO
Applicant:	Provepharm Sas
Ingredient:	indigotindisulfonate sodium
Patents:	3

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

Pharmacology for NDA: 216264

Mechanism of Action

Dyes

Suppliers and Packaging for NDA: 216264

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264	NDA	Provepharm Inc.	81284-315	81284-315-05	5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	40MG/5ML (8MG/ML)
Approval Date:	Jul 8, 2022	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 8, 2027
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:		Patent Expiration:	Dec 23, 2037	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:		Patent Expiration:	Dec 23, 2037	Product Flag?		Substance Flag?	Y	Delist Request?

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