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Last Updated: August 6, 2020

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TEPADINA Drug Profile

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When do Tepadina patents expire, and when can generic versions of Tepadina launch?

Tepadina is a drug marketed by Adienne Sa and is included in one NDA.

The generic ingredient in TEPADINA is thiotepa. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the thiotepa profile page.

US ANDA Litigation and Generic Entry Outlook for Tepadina

A generic version of TEPADINA was approved as thiotepa by WEST-WARD PHARMS INT on April 2nd, 2001.

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Drug patent expirations by year for TEPADINA
Recent Clinical Trials for TEPADINA

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SponsorPhase
University of BirminghamPhase 3
National Heart, Lung, and Blood Institute (NHLBI)Phase 2
Fred Hutchinson Cancer Research CenterPhase 2

See all TEPADINA clinical trials

Pharmacology for TEPADINA
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

US Patents and Regulatory Information for TEPADINA

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 208264-002 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
Adienne Sa TEPADINA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 208264-002 Jan 26, 2017 AP 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

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