Viewing data from:

BLUDIGO

NDA

INDIGOTINDISULFONATE SODIUM | N216264 | PROVEPHARM SAS

1 strength3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

10927258

Dec. 23, 2037

11499050

Dec. 23, 2037

11845867

Nov. 25, 2036

NCE

Jul. 8, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Functional Brain MRI to Understand Pain Phenotypes in Knee Osteoarthritis NCT07668674	Phase 2	Not Yet Recruiting	University Hospital, Clermont-Ferrand	60	2026-07 → 2028-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain3 active DMFs1 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

DISHMAN CARBOGEN AMCIS LTDINDIGOTINDISULFONATE SODIUM USP

DMF 329102018

MACSEN DRUGSINDIGOTINDISULFONATE SODIUM USP

DMF 401192024

SICHUAN ELIXIR PHARMACEUTICAL CO LTDINDIGOTINDISULFONATE SODIUM

DMF 431802025

DISHMAN CARBOGEN AMCIS LTDInactiveINDIGOTINDISULFONATE SODIUM

DMF 327022018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 17, 2023	SUPPL -1	View Letter (PDF)
Jul 11, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/5ML (8MG/ML)

RLD

3 patents1 exclusivity▴

SOLUTION;INTRAVENOUS | Approved: Jul 8, 2022

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10927258	Dec 23, 2037	—	Yes	—	—	—
11499050	Dec 23, 2037	—	Yes	—	—	—
11845867	Nov 25, 2036	—	Yes	—	—	—

Exclusivities (1)

Code	Date	Status
NCE	Jul 8, 2027	Active