Viewing data from:

NAVELBINE

NDA

VINORELBINE TARTRATE | N020388 | PIERRE FABRE MEDICAMENT

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

5 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
To Describe How Well Vinorelbine Given Orally Works in Patients With a Breast Cancer After 2 Years of Treatment NCT06500494	—	Active	Pierre Fabre Medicament	368	2024-09-10 → 2028-09
Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma NCT03618550	Phase 2	Recruiting	Memorial Sloan Kettering Cancer Center	257	2018-08-01 → 2026-08
Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer NCT06632327	Phase 3	Recruiting	Alliance for Clinical Trials in Oncology	1,100	2024-12-11 → 2030-04-30
Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery NCT00324805	Phase 3	Completed	National Cancer Institute (NCI)	1,501	2007-07-19 → 2025-01-31
Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer NCT03801304	Phase 2	Completed	University Hospital, Brest	80	2019-01-24 → 2022-02-23

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

Medicare Part B Spending

CMS physician-administered drug spending for Navelbine (2023)

Total Spending

$128K

Total Claims

3,679

Beneficiaries

473

ASP Price

—

HCPCS: J9390 — Injection, vinorelbine tartrate, 10 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain3 active DMFs8 inactive

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

PIERRE FABRE MEDICAMENTVINORELBINE TARTRATE

DMF 94771991

MINAKEM HIGH POTENTVINORELBINE TARTRATE

DMF 146191999

HUBEI HONCH PHARMACEUTICAL CO LTDVINORELBINE TARTRATE

DMF 260912013

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveVINORELBINE TARTRATE USP

DMF 159562002

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDInactiveVINORELBINE TARTRATE USP

DMF 160112002

EXOPHARM CO LTDInactiveVINORELBINE TARTRATE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 190942006

CIPLA LTDInactiveVINORELBINE TARTRATE USP

DMF 201582009

SYNBIAS PHARMA LTDInactiveVINORELBINE TARTRATE

DMF 219292008

ALP PHARM BEIJING CO LTDInactiveVINORELBINE TARTRATE

DMF 239512010

QILU PHARMACEUTICAL CO LTDInactiveVINORELBINE TARTRATE (PROCESS I) (NON STERILE, API)

DMF 252032011

SYNBIAS PHARMA AGInactiveVINORELBINE TARTRATE

DMF 282212014

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jan 27, 2020	SUPPL -37	View Letter (PDF)
May 13, 2019	SUPPL -36	View Letter (PDF)
Jun 27, 2018	SUPPL -35	View Letter (PDF)
Mar 19, 2014	SUPPL -27	View Letter (PDF)
Jul 24, 2003	SUPPL -10	View Letter (PDF)
Nov 5, 2002	SUPPL -14	View Letter (PDF)
Jun 8, 2000	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

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

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 23, 1994

No patent or exclusivity listings for this strength.