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Generated: October 21, 2017

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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 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.

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 Generic Name: vincristine sulfate

US Patents:3
Tradenames:6
Applicants:9
NDAs:13
Drug Master File Entries: see list13
Suppliers / Packagers: see list3
Bulk Api Vendors: see list62
Clinical Trials: see list1,380
Patent Applications: see list9,912
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:vincristine sulfate at DailyMed

Pharmacology for Ingredient: vincristine sulfate

Ingredient-typeVinca Alkaloids
Drug ClassVinca Alkaloid
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;INJECTION014103-003Mar 7, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe
Lilly
ONCOVIN
vincristine sulfate
INJECTABLE;INJECTION014103-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Teva Parenteral
VINCASAR PFS
vincristine sulfate
INJECTABLE;INJECTION071426-001Jul 17, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Hospira
VINCRISTINE SULFATE
vincristine sulfate
INJECTABLE;INJECTION071559-001Apr 11, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
VINCRISTINE SULFATE
vincristine sulfate
INJECTABLE;INJECTION076401-001Oct 28, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
VINCRISTINE SULFATE
vincristine sulfate
INJECTABLE;INJECTION071561-001Apr 11, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
VINCRISTINE SULFATE
vincristine sulfate
INJECTABLE;INJECTION076296-001Dec 20, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012RXYesYes► Subscribe► 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
Lilly
ONCOVIN
vincristine sulfate
INJECTABLE;INJECTION014103-003Mar 7, 1984► Subscribe► Subscribe
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012► Subscribe► Subscribe
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012► Subscribe► Subscribe
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012► Subscribe► 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
7,452,550Liposomal antineoplastic drugs and uses thereof► Subscribe
7,060,828Liposomal camptothecins and uses thereof► Subscribe
7,244,450Compositions and methods for treating lymphoma► Subscribe
7,311,924Compositions and methods for treating cancer► Subscribe
7,244,448Liposomal antineoplastic drugs and uses thereof► 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
Austria442839► Subscribe
Israel212389► Subscribe
Austria309787► Subscribe
Denmark2266537► Subscribe
China1446079► Subscribe
Spain2524141► Subscribe
Spain2253398► Subscribe
Australia7038501► Subscribe
Germany60042968► Subscribe
Portugal1169021► 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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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Chinese Patent Office
Fuji
Cerilliant
Johnson and Johnson
Novartis
US Department of Justice
Baxter
Argus Health

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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