THIOTEPA - Generic Drug Details

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

Thiotepa is the generic ingredient in four 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, Meitheal, MSN, and Shorla, and is included in sixteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Thiotepa has two patent family members in one country.

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

Summary for THIOTEPA

International Patents:	2
US Patents:	1
Tradenames:	4
Applicants:	14
NDAs:	16
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	243
Patent Applications:	7,491
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
City of Hope Medical Center	Phase 1
National Cord Blood Network	Phase 2
Fred Hutchinson Cancer Center	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

Anatomical Therapeutic Chemical (ATC) Classes for THIOTEPA

L01AC	Ethylene imines
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Gland Pharma Ltd	THIOTEPA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	214222-001	Mar 8, 2021	AP	RX	No	No
Hikma	THIOTEPA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	211755-001	Sep 5, 2023	AP	RX	No	No
Teva Parenteral	THIOTEPA	thiotepa	INJECTABLE;INJECTION	075730-002	Apr 20, 2001		DISCN	No	No
Adienne Sa	TEPADINA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	208264-001	Jan 26, 2017	AP	RX	Yes	Yes
Beloteca	THIOTEPA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	217559-001	Aug 20, 2024	AP	RX	No	No
Teva Parenteral	THIOTEPA	thiotepa	INJECTABLE;INJECTION	075730-001	Apr 20, 2001		DISCN	No	No

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

International Patents for THIOTEPA

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2023156911
World Intellectual Property Organization (WIPO)	2022038490