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Vincristine sulfate - Generic Drug Details

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What are the generic sources for vincristine sulfate and what is the scope of vincristine sulfate patent protection?

Vincristine sulfate is the generic ingredient in six branded drugs marketed by Talon Therap, Lilly, Teva Parenteral, Bristol Myers Squibb, Abic, Abraxis Pharm, Fresenius Kabi Usa, Hospira, and Teva Pharms Usa, and is included in thirteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vincristine sulfate has forty-five patent family members in sixteen countries.

There are thirteen drug master file entries for vincristine sulfate. Three suppliers are listed for this compound.

Summary for vincristine sulfate

International Patents:	45
US Patents:	3
Tradenames:	6
Applicants:	9
NDAs:	13
Drug Master File Entries:	13
Suppliers / Packagers:	3
Bulk Api Vendors:	31
Clinical Trials:	118
Patent Applications:	7,562
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for vincristine sulfate
DailyMed Link:	vincristine sulfate at DailyMed

Pharmacology for vincristine sulfate

Ingredient-type	Vinca Alkaloids
Drug Class	Vinca Alkaloid

Medical Subject Heading (MeSH) Categories for vincristine sulfate

Antineoplastic Agents, Phytogenic

Tubulin Modulators

US Patents and Regulatory Information for vincristine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Parenteral	VINCASAR PFS	vincristine sulfate	INJECTABLE;INJECTION	071426-001	Jul 17, 1987		DISCN	No	No
Fresenius Kabi Usa	VINCRISTINE SULFATE	vincristine sulfate	INJECTABLE;INJECTION	076401-001	Oct 28, 2003		DISCN	No	No
Talon Therap	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012		RX	Yes	Yes			Y
Talon Therap	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012		RX	Yes	Yes

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Expired US Patents for vincristine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Talon Therap	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012
Talon Therap	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012
Talon Therap	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012
Lilly	ONCOVIN	vincristine sulfate	INJECTABLE;INJECTION	014103-003	Mar 7, 1984

Non-Orange Book US Patents for vincristine sulfate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,060,828	Liposomal camptothecins and uses thereof
7,244,448	Liposomal antineoplastic drugs and uses thereof
7,244,450	Compositions and methods for treating lymphoma
7,311,924	Compositions and methods for treating cancer

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International Patents for vincristine sulfate

Country	Document Number	Estimated Expiration
Australia	777572
Israel	212390
Israel	153676
European Patent Office	1299084