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Last Updated: March 4, 2021

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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 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

SponsorPhase
Acrotech BiopharmaPhase 2
David Rizzieri, MDPhase 2
Mayo ClinicPhase 1

See all vincristine sulfate clinical trials

Pharmacology for vincristine sulfate
Drug ClassVinca Alkaloid
Medical Subject Heading (MeSH) Categories for vincristine sulfate
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

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

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

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