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MARQIBO KIT

NDA

VINCRISTINE SULFATE | N202497 | ACROTECH BIOPHARMA 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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs8 inactive

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

MINAKEM HIGH POTENTVINCRISTINE SULFATE

DMF 49321983

HUBEI HONCH PHARMACEUTICAL CO LTDVINCRISTINE SULFATE

DMF 399432024

GEDEON RICHTER LTDInactiveVINCRISTINE SULFATE

DMF 35071979

PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKSInactiveVINCRISTINE SULFATE USP

DMF 48621983

CHEMWERTH INCInactiveVINCRISTINE SULFATE

DMF 62211986

SAPCOL INTERNATIONAL LTDInactiveVINCRISTINE

DMF 62901986

CIPLA LTDInactiveVINCRISTINE SULFATE USP

DMF 65001986

ADITHYA ALKALOIDS LTDInactiveVINCRISTINE SULFATE

DMF 112851995

HANA BIOSCIENCES INCInactiveVINCRISTINE SULFATE LIPOSOME INJECTION

DMF 126261997

GUANGZHOU HUANYE PHARMACEUTICAL CO LTDInactiveVINCRISTINE SULFATE USP (NON-STERILE BULK DRUG)

DMF 185792005

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG/5ML (1MG/ML)

RLD

0 patents0 exclusivities▴

INJECTABLE, LIPOSOMAL;INTRAVENOUS | Approved: Aug 9, 2012

No patent or exclusivity listings for this strength.