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Last Updated: June 25, 2021

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Vincristine sulfate - Generic Drug Details

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What are the generic drug sources for vincristine sulfate and what is the scope of freedom to operate?

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. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for vincristine sulfate. Two suppliers are listed for this compound.

Summary for vincristine sulfate
Recent Clinical Trials for vincristine sulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Yazeed SawalhaPhase 1
Acrotech BiopharmaPhase 2
David Rizzieri, MDPhase 2

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
Hospira VINCRISTINE SULFATE vincristine sulfate INJECTABLE;INJECTION 071559-001 Apr 11, 1988 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Fresenius Kabi Usa VINCRISTINE SULFATE vincristine sulfate INJECTABLE;INJECTION 076296-001 Dec 20, 2002 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Abic VINCRISTINE SULFATE vincristine sulfate INJECTABLE;INJECTION 070873-001 Feb 19, 1987 DISCN No No   Get Started Free   Get Started Free   Get Started Free
>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   Get Started Free   Get Started Free
Acrotech MARQIBO KIT vincristine sulfate INJECTABLE, LIPOSOMAL;INTRAVENOUS 202497-001 Aug 9, 2012   Get Started Free   Get Started Free
Lilly ONCOVIN vincristine sulfate INJECTABLE;INJECTION 014103-003 Mar 7, 1984   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Merck
McKinsey
AstraZeneca
Baxter

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