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Last Updated: March 29, 2024

VINORELBINE TARTRATE - Generic Drug Details


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What are the generic drug sources for vinorelbine tartrate and what is the scope of patent protection?

Vinorelbine tartrate is the generic ingredient in two branded drugs marketed by Pierre Fabre, Actavis Totowa, Dr Reddys, Ebewe Pharma, Fresenius Kabi Usa, Hikma, Hospira, Jiangsu Hansoh Pharm, Mylan Labs Ltd, Novast Labs, and Teva Pharms Usa, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for vinorelbine tartrate. Two suppliers are listed for this compound.

Summary for VINORELBINE TARTRATE
Recent Clinical Trials for VINORELBINE TARTRATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Phase 3
Qilu Pharmaceutical Co., Ltd.Phase 3
Zhiyong YuPhase 2

See all VINORELBINE TARTRATE clinical trials

Pharmacology for VINORELBINE TARTRATE
Drug ClassVinca Alkaloid

US Patents and Regulatory Information for VINORELBINE TARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novast Labs VINORELBINE TARTRATE vinorelbine tartrate INJECTABLE;INJECTION 208997-001 Aug 5, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jiangsu Hansoh Pharm VINORELBINE TARTRATE vinorelbine tartrate INJECTABLE;INJECTION 091106-001 Sep 26, 2012 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pierre Fabre NAVELBINE vinorelbine tartrate INJECTABLE;INJECTION 020388-001 Dec 23, 1994 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira VINORELBINE TARTRATE vinorelbine tartrate INJECTABLE;INJECTION 076827-001 Jun 2, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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