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Serving leading biopharmaceutical companies globally:

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Generated: December 18, 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 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.

Pharmacology for vincristine sulfate

Ingredient-typeVinca Alkaloids
Drug ClassVinca Alkaloid

Medical Subject Heading (MeSH) Categories 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 Pharms UsaVINCRISTINE SULFATE PFSvincristine sulfateINJECTABLE;INJECTION075493-001Sep 1, 1999APRXNoNo► Subscribe► Subscribe► Subscribe
AbicVINCRISTINE SULFATEvincristine sulfateINJECTABLE;INJECTION070873-001Feb 19, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Talon TherapMARQIBO KITvincristine sulfateINJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Talon TherapMARQIBO KITvincristine sulfateINJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012RXYesYes► Subscribe► Subscribe► Subscribe
HospiraVINCRISTINE SULFATEvincristine sulfateINJECTABLE;INJECTION071560-001Apr 11, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
HospiraVINCRISTINE SULFATEvincristine sulfateINJECTABLE;INJECTION071561-001Apr 11, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Abraxis PharmVINCRISTINE SULFATEvincristine sulfateINJECTABLE;INJECTION070411-001Sep 10, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaVINCRISTINE SULFATEvincristine sulfateINJECTABLE;INJECTION076296-001Dec 20, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Bristol Myers SquibbVINCREXvincristine sulfateINJECTABLE;INJECTION070867-001Jul 12, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
LillyONCOVINvincristine sulfateINJECTABLE;INJECTION014103-003Mar 7, 1984DISCNNoNo► 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
Talon TherapMARQIBO KITvincristine sulfateINJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012► Subscribe► Subscribe
LillyONCOVINvincristine sulfateINJECTABLE;INJECTION014103-003Mar 7, 1984► Subscribe► Subscribe
Talon TherapMARQIBO KITvincristine sulfateINJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012► Subscribe► Subscribe
Talon TherapMARQIBO KITvincristine sulfateINJECTABLE, 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
7,311,924Compositions and methods for treating cancer► Subscribe
7,244,450Compositions and methods for treating lymphoma► 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
Israel145720► Subscribe
Cyprus1109641► Subscribe
Germany60115044► Subscribe
European Patent Office1299085► Subscribe
Canada2366787► Subscribe
Japan2002541088► Subscribe
Japan2015071631► Subscribe
European Patent Office2266537► Subscribe
Japan2012092148► Subscribe
Austria442839► 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:

US Army
Chubb
Teva
Cantor Fitzgerald
QuintilesIMS
Cerilliant
Accenture
AstraZeneca
Express Scripts
Federal Trade Commission

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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