Vincristine sulfate - Generic Drug Details

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

Vincristine sulfate is the generic ingredient in six branded drugs marketed by Acrotech, 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-six patent family members in sixteen countries.

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

Summary for vincristine sulfate

International Patents:	46
US Patents:	3
Tradenames:	6
Applicants:	9
NDAs:	13
Drug Master File Entries:	13
Suppliers / Packagers:	2
Bulk Api Vendors:	41
Clinical Trials:	139
Patent Applications:	7,468
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in vincristine sulfate?	vincristine sulfate excipients list
DailyMed Link:	vincristine sulfate at DailyMed

Recent Clinical Trials for vincristine sulfate

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

Sponsor	Phase
Acrotech Biopharma	Phase 2
David Rizzieri, MD	Phase 2
Mayo Clinic	Phase 1

See all vincristine sulfate clinical trials

Pharmacology for vincristine sulfate

Drug Class	Vinca Alkaloid

Medical Subject Heading (MeSH) Categories for vincristine sulfate

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Paragraph IV (Patent) Challenges for VINCRISTINE SULFATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
ONCOVIN	INJECTABLE;INJECTION	vincristine sulfate	014103

US Patents and Regulatory Information for vincristine sulfate

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Glossary

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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
Lilly	ONCOVIN	vincristine sulfate	INJECTABLE;INJECTION	014103-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Fresenius Kabi Usa	VINCRISTINE SULFATE	vincristine sulfate	INJECTABLE;INJECTION	076401-001	Oct 28, 2003		DISCN	No	No	Start Trial	Start Trial				Start Trial
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for vincristine sulfate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	Start Trial	Start Trial
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	Start Trial	Start Trial
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for vincristine sulfate

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Country	Patent Number	Estimated Expiration
Australia	7038501	Start Trial
Japan	2014088444	Start Trial
Germany	60115045	Start Trial
>Country	>Patent Number	>Estimated Expiration

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