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Last Updated: March 28, 2024

THIOPLEX Drug Patent Profile


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Which patents cover Thioplex, and what generic alternatives are available?

Thioplex is a drug marketed by Immunex and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Thioplex

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

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

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

SponsorPhase
Baptist Health South FloridaPhase 2
St. Jude Children's Research HospitalPhase 2
Massachusetts General HospitalPhase 1/Phase 2

See all THIOPLEX clinical trials

US Patents and Regulatory Information for THIOPLEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Immunex THIOPLEX thiotepa INJECTABLE;INJECTION 020058-001 Dec 22, 1994 DISCN Yes 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 THIOPLEX

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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