VINORELBINE TARTRATE Drug Patent Profile

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Vinorelbine Tartrate is a drug marketed by 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 eleven NDAs.

The generic ingredient in VINORELBINE TARTRATE is vinorelbine tartrate. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vinorelbine tartrate profile page.

A generic version of VINORELBINE TARTRATE was approved as vinorelbine tartrate by HIKMA on June 10^th, 2003.

US Patents:	0
Applicants:	10
NDAs:	11
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	80
Patent Applications:	7,215
Formulation / Manufacturing:	see details
DailyMed Link:	VINORELBINE TARTRATE at DailyMed

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

Sponsor	Phase
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 3
Qilu Pharmaceutical Co., Ltd.	Phase 3
Zhiyong Yu	Phase 2

Drug Class	Vinca Alkaloid

L01CA	Vinca alkaloids and analogues
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Totowa	VINORELBINE TARTRATE	vinorelbine tartrate	INJECTABLE;INJECTION	078011-001	Jul 22, 2009	AP	RX	No	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
Fresenius Kabi Usa	VINORELBINE TARTRATE	vinorelbine tartrate	INJECTABLE;INJECTION	076849-001	Apr 18, 2005		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
Dr Reddys	VINORELBINE TARTRATE	vinorelbine tartrate	INJECTABLE;INJECTION	202017-001	Sep 12, 2013	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ebewe Pharma	VINORELBINE TARTRATE	vinorelbine tartrate	INJECTABLE;INJECTION	078408-001	Feb 13, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	VINORELBINE TARTRATE	vinorelbine tartrate	INJECTABLE;INJECTION	076461-001	Dec 11, 2003	AP	RX	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