You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 3, 2024

Thiotepa - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, Dr Reddys, Fresenius Kabi Usa, Hengrui Pharma, Penn Life, Teva Parenteral, West-ward Pharms Int, Adienne Sa, Gland Pharma Ltd, Hikma, Kindos, and MSN, and is included in fourteen 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

See drug prices for thiotepa

Recent Clinical Trials for thiotepa

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

SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
First Affiliated Hospital of Zhejiang UniversityPhase 2
TScan Therapeutics, Inc.Phase 1

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
Immunex THIOTEPA thiotepa INJECTABLE;INJECTION 011683-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Adienne Sa TEPADINA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 208264-002 Jan 26, 2017 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Beloteca THIOTEPA thiotepa INJECTABLE;INJECTION 211831-001 Dec 8, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma THIOTEPA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 211755-001 Sep 5, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
West-ward Pharms Int THIOTEPA thiotepa INJECTABLE;INJECTION 075547-001 Apr 2, 2001 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd THIOTEPA thiotepa POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL 214222-001 Mar 8, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.