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Vincristine sulfate - Generic Drug Details

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

This ingredient has forty-one 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 Generic Name: vincristine sulfate

Tradenames:6
Patents:3
Applicants:9
NDAs:13
Drug Master File Entries: see list13
Suppliers / Packaging: see list3
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: vincristine sulfate

Ingredient-typeVinca Alkaloids
Drug ClassVinca Alkaloid
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012RXYes7,247,316► subscribeY ► subscribe
Fresenius Kabi Usa
VINCRISTINE SULFATE
vincristine sulfate
INJECTABLE;INJECTION076401-001Oct 28, 2003DISCNNo► subscribe► subscribe
Bristol Myers Squibb
VINCREX
vincristine sulfate
INJECTABLE;INJECTION070867-001Jul 12, 1988DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: vincristine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 20125,814,335► subscribe
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 20125,543,152► subscribe
Lilly
ONCOVIN
vincristine sulfate
INJECTABLE;INJECTION014103-003Mar 7, 19844,619,935► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
7,060,828Liposomal camptothecins and uses thereof► subscribe
7,452,550Liposomal antineoplastic drugs and uses thereof► subscribe
7,311,924Compositions and methods for treating cancer► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: vincristine sulfate

Country Document Number Estimated Expiration
Germany60115044► subscribe
European Patent Office1299085► subscribe
Japan2002541088► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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