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VELBAN

NDA

VINBLASTINE SULFATE | N012665 | ELI LILLY AND CO

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

3 trials from ClinicalTrials.gov — 1 recruiting, 2 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma NCT03907488	Phase 3	Active	National Cancer Institute (NCI)	994	2019-08-29 → 2027-03-28
A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma NCT04576117	Phase 3	Active	National Cancer Institute (NCI)	300	2021-02-16 → 2026-12-30
Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer NCT04628767	Phase 2/3	Recruiting	National Cancer Institute (NCI)	131	2021-11-12 → 2027-09-30

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

API Supply Chain3 active DMFs3 inactive

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

MINAKEM HIGH POTENTVINBLASTINE SULFATE

DMF 53351984

HUBEI HONCH PHARMACEUTICAL CO LTDVINBLASTINE SULFATE PHARMACEUTICAL INTERMEDATE

DMF 392642024

HUBEI HONCH PHARMACEUTICAL CO LTDVINBLASTINE SULFATE NON-STERILE, BULK DRUG SUBSTANCE

DMF 399442025

CIPLA LTDInactiveVINBLASTINE SULFATE USP

DMF 64991986

ADITHYA ALKALOIDS LTDInactiveVINBLASTINE SULFATE

DMF 112841995

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveVINBLASTINE SULFATE USP

DMF 162402002

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

Products (1)

#001 — 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.