Thiotepa - Generic Drug Details

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.

Summary for thiotepa

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	12
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	234
Patent Applications:	7,569
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for thiotepa
What excipients (inactive ingredients) are in thiotepa?	thiotepa excipients list
DailyMed Link:	thiotepa at DailyMed

See drug prices for thiotepa

Recent Clinical Trials for thiotepa

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

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

See all thiotepa clinical trials

Pharmacology for thiotepa

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for thiotepa

Antineoplastic Agents, Alkylating

Myeloablative Agonists

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
Gland Pharma Ltd	THIOTEPA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	214222-002	Jan 3, 2022	AP	RX	No	No
Adienne Sa	TEPADINA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	208264-002	Jan 26, 2017	AP	RX	Yes	Yes

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