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Last Updated: August 6, 2020

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Thiotepa - Generic Drug Details

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What are the generic sources for thiotepa and what is the scope of freedom to operate?

Thiotepa is the generic ingredient in three branded drugs marketed by Immunex, Dr Reddys, Fresenius Kabi Usa, Jiangsu Hengrui Med, Sti Pharma Llc, Teva Parenteral, West-ward Pharms Int, Adienne Sa, and MSN, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for thiotepa. Five suppliers are listed for this compound.

Drug Prices for thiotepa

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Recent Clinical Trials for thiotepa

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

SponsorPhase
Baptist Health South FloridaPhase 2
University of BirminghamPhase 3
Gustave Roussy, Cancer Campus, Grand ParisPhase 3

See all thiotepa clinical trials

Pharmacology for thiotepa
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for thiotepa

US Patents and Regulatory Information for thiotepa

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Adienne Sa TEPADINA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 208264-001 Jan 26, 2017 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Adienne Sa TEPADINA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 208264-001 Jan 26, 2017 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Msn THIOTEPA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 213049-002 Mar 4, 2020 AP RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys THIOTEPA thiotepa INJECTABLE;INJECTION 210337-001 May 4, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Teva Parenteral THIOTEPA thiotepa INJECTABLE;INJECTION 075730-002 Apr 20, 2001 DISCN No No   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

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