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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

319 trials from ClinicalTrials.gov — 7 recruiting, 14 active, 183 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)NCT05104866	Phase 3	Active	AstraZeneca	732	2021-10-18 → 2026-12-31
Surufatinib or Surufatinib Combined With Vinorelbine for Non-Small Cell Lung Cancer NCT04922658	Phase 2	Active	Affiliated Cancer Hospital & Institute of Guangzhou Medical University	76	2020-06-03 → 2026-12-31
Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer NCT06632327	Phase 3	Active	Alliance for Clinical Trials in Oncology	37	2024-12-11 → 2030-04-30
Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]NCT02486718	Phase 3	Active	Hoffmann-La Roche	1,280	2015-10-31 → 2027-08-31
Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma NCT02567435	Phase 3	Active	National Cancer Institute (NCI)	325	2016-06-01 → 2026-10-27
A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma NCT04994132	Phase 3	Active	Children's Oncology Group	113	2021-09-14 → 2027-07-01
Mocetinostat With Vinorelbine in Children, Adolescents & Young Adults With Refractory and/or Recurrent Rhabdomyosarcoma NCT04299113	Phase 1	Active	Jonsson Comprehensive Cancer Center	14	2020-05-14 → 2027-12-30
A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)NCT06459180	Phase 3	Active	Merck Sharp & Dohme LLC	686	2024-07-24 → 2028-06-15
The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer NCT03414658	Phase 2	Active	Adrienne G. Waks	100	2018-06-21 → 2027-05-31
A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features NCT06564844	Phase 3	Active	AstraZeneca	25	2024-10-15 → 2027-06-30

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Medicare Part D Spending

CMS annual spending data for Vinorelbine Tartrate (2024)

Total Spending

$18K

Total Claims

128

Beneficiaries

Avg Cost/Unit

$14.08

Spending Trend

$24K(2019)→$28K(2020)→$27K(2021)→$23K(2022)→$13K(2023)→$18K(2024)

YoY Change:-12.0%

5yr CAGR:-4.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Navelbine (2024)

Total Spending

$96K

Total Claims

2,839

Beneficiaries

368

ASP Price

$7.93

Spending Trend

$378K(2019)→$221K(2020)→$257K(2021)→$191K(2022)→$128K(2023)→$96K(2024)

YoY Change:-3.6%

5yr CAGR:+2.0%

HCPCS: J9390 — Injection, vinorelbine tartrate, 10 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain4 active DMFs10 inactive

4 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

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDVINORELBINE TARTRATE, USP

DMF 314802017

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveVINORELBINE TARTRATE USP

DMF 159562002

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDInactiveVINORELBINE TARTRATE USP

DMF 160112002

ERIOCHEM SAInactiveVINORELBINE TARTRATE, USP

DMF 167062003

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

GUANGZHOU HANFANG PHARMACEUTICAL CO LTDInactiveVINORELBINE TARTRATE, USP

DMF 257832012

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.