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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

Pharmacology for Ingredient: vincristine sulfate

Ingredient-typeVinca Alkaloids
Drug ClassVinca Alkaloid

Clinical Trials for: vincristine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
VINCREX
vincristine sulfate
INJECTABLE;INJECTION070867-001Jul 12, 1988DISCNNo<disabled><disabled>
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012RXYes7,247,316<disabled>Y <disabled>
Lilly
ONCOVIN
vincristine sulfate
INJECTABLE;INJECTION014103-002Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: vincristine sulfate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 20125,543,152<disabled>
Lilly
ONCOVIN
vincristine sulfate
INJECTABLE;INJECTION014103-003Mar 7, 19844,619,935<disabled>
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 20125,814,335<disabled>
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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
7,244,448Liposomal antineoplastic drugs and uses thereof<disabled in preview>
7,452,550Liposomal antineoplastic drugs and uses thereof<disabled in preview>
7,244,450Compositions and methods for treating lymphoma<disabled in preview>
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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
Canada2366787<disabled in preview>
European Patent Office1985285<disabled in preview>
China1446079<disabled in preview>
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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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