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Last Updated: November 24, 2024

MITOMYCIN Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Mitomycin

A generic version of MITOMYCIN was approved as mitomycin by HIKMA on April 19th, 1995.

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Drug patent expirations by year for MITOMYCIN
Drug Prices for MITOMYCIN

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Recent Clinical Trials for MITOMYCIN

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SponsorPhase
City of Hope Medical CenterPhase 2
Columbia UniversityN/A
VarianN/A

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Pharmacology for MITOMYCIN
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for MITOMYCIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JELMYTO Powder for Injection mitomycin 40 mg/vial 211728 1 2023-12-28

US Patents and Regulatory Information for MITOMYCIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare MITOMYCIN mitomycin INJECTABLE;INJECTION 064144-001 Apr 30, 1998 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira MITOMYCIN mitomycin INJECTABLE;INJECTION 064106-001 Nov 29, 1995 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rk Pharma MITOMYCIN mitomycin INJECTABLE;INJECTION 203386-001 Oct 13, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa MITOMYCIN mitomycin INJECTABLE;INJECTION 211269-001 Apr 5, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma MITOMYCIN mitomycin INJECTABLE;INJECTION 216732-001 Oct 30, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gland Pharma Ltd MITOMYCIN mitomycin INJECTABLE;INJECTION 216648-001 Nov 22, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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