Viewing data from:

EXTRANEAL

NDA

ICODEXTRIN | N021321 | VANTIVE US HEALTHCARE LLC

1 strength0 unique patents0 unique exclusivities

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
Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal Dialysis NCT05721404	Phase 4	Recruiting	First Affiliated Hospital, Sun Yat-Sen University	194	2023-05-24 → 2027-12-31

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

VANTIVE US HEALTHCARE LLCICODEXTRIN POWDER

DMF 140721999

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

Approval Letters

16 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 7.5GM/100ML

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAPERITONEAL | Approved: Dec 20, 2002

No patent or exclusivity listings for this strength.