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Last Updated: December 1, 2022

Thiotepa - Generic Drug Details


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

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

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

Drug Prices for thiotepa

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Recent Clinical Trials for thiotepa

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SponsorPhase
First Affiliated Hospital of Zhejiang UniversityPhase 2
TScan Therapeutics, Inc.Phase 1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 2

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Pharmacology for thiotepa
Drug Class Alkylating 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
Msn THIOTEPA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 213049-002 Mar 4, 2020 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gland Pharma Ltd THIOTEPA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 214222-002 Jan 3, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Adienne Sa TEPADINA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 208264-002 Jan 26, 2017 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for thiotepa

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
ADIENNE S.r.l. S.U. Tepadina thiotepa EMEA/H/C/001046
In combination with other chemotherapy medicinal products:, , , with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;, when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.". It is proposed that Tepadina must be prescribed by physicians experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation., ,
Authorised no no no 2010-03-15
Esteve Pharmaceuticals GmbH Thiotepa Riemser thiotepa EMEA/H/C/005434
Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients
Authorised yes no no 2021-03-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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