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:	7,329
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
Fred Hutchinson Cancer Center	Phase 2
National Cord Blood Network	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	214222-002	Jan 3, 2022	AP	RX	No	No
Gland Pharma Ltd	THIOTEPA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	214222-001	Mar 8, 2021	AP	RX	No	No
Fresenius Kabi Usa	THIOTEPA	thiotepa	INJECTABLE;INJECTION	075698-001	Sep 20, 2001		DISCN	No	No
Shorla	TEPYLUTE	thiotepa	SOLUTION;INTRAVENOUS	216984-001	Jun 25, 2024		RX	Yes	Yes			Y
Beloteca	THIOTEPA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	217559-001	Aug 20, 2024	AP	RX	No	No
Meitheal	THIOTEPA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	216037-002	Dec 26, 2023	AP	RX	No	No
Hengrui Pharma	THIOTEPA	thiotepa	INJECTABLE;INJECTION	209150-001	May 4, 2018	AP	RX	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)	2022038490
World Intellectual Property Organization (WIPO)	2023156911

THIOTEPA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Thiotepa

Introduction to Thiotepa

Thiotepa is a well-established chemotherapeutic agent belonging to the class of alkylating agents. It is used in the treatment of various cancers, including blood diseases and solid tumors, particularly in the context of hematopoietic progenitor cell transplantation (HPCT)[1].

Market Size and Growth Projections

The thiotepa market is experiencing significant growth, driven by its increasing use in oncology treatments. Here are some key points regarding the market size and growth projections:

• Current Market Value: The thiotepa API market reached a substantial value in 2023 and is anticipated to grow further, reaching a projected value by 2031. This growth is attributed to the expanding use of thiotepa in cancer treatments and the development of new formulations[2].
• Compound Annual Growth Rate (CAGR): The market is expected to exhibit a notable CAGR from 2024 to 2031, indicating a sustained and significant expansion. This growth is fueled by the increasing demand for effective cancer treatments and the advancements in drug formulations[2][4].

Market Segmentation

The thiotepa market is segmented based on several factors:

• Type: The market is categorized by the purity of thiotepa, with segments including purity ≥98% and purity <98%. This segmentation helps in understanding the quality and application-specific demand for thiotepa[2].
• Application: Thiotepa is used in various applications, primarily in injectable forms. The market report also includes other applications, highlighting the versatility of the drug[2].
• Geographical Regions: The market is analyzed across different geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. This segmentation provides insights into regional demand and growth opportunities[2].

Drivers and Restraints

Drivers

• Increasing Cancer Incidence: The rising incidence of cancers, such as breast and ovarian cancer, drives the demand for effective chemotherapeutic agents like thiotepa. For instance, the American Cancer Society estimates that over 300,000 women will be diagnosed with breast cancer in the U.S. in 2024[3].
• Advancements in Formulations: The development of new, more convenient formulations, such as the ready-to-dilute TEPYLUTE approved by the FDA, enhances the usability and accuracy of thiotepa administration. This reduces preparation time and medical personnel exposure to hazardous drugs[3].
• Growing Need for Conditioning Treatments: Thiotepa is crucial in conditioning treatments prior to HPCT, which is a growing area in oncology. Its use in combination with other chemotherapy agents and total body irradiation (TBI) supports the market growth[1].

Restraints

• Side Effects and Safety Concerns: Thiotepa is associated with several side effects, including infections, cytopenia, graft-versus-host disease, and mucosal inflammation. These safety concerns can limit its use and impact market growth[1].
• Regulatory Restrictions: Thiotepa must not be used in pregnant or breastfeeding women and should not be administered with certain vaccines, which can restrict its market potential[1].

Competitive Landscape

The thiotepa market is characterized by a competitive landscape involving several key players:

• Shorla Oncology: Known for its innovative formulations, Shorla Oncology recently received FDA approval for TEPYLUTE, a ready-to-dilute formulation of thiotepa. This company is also developing other oncology drugs, including treatments for leukemia and other cancers[3].
• Other Key Players: Companies like Heraeus Deutschland GmbH & Co. KG, IDT Australia, MSN Laboratories, Natco Pharma, and Emcure Pharmaceuticals are significant players in the thiotepa API market. These companies contribute to the market through their product offerings, strategic market approaches, and geographical reach[2].

Financial Trajectory

The financial trajectory of the thiotepa market is positive, with several indicators pointing to sustained growth:

• Revenue Projections: The market is expected to generate substantial revenue by 2031, driven by the increasing demand for thiotepa in cancer treatments and the introduction of new formulations[2][4].
• Investment and Development: Companies are investing heavily in research and development to improve thiotepa formulations and expand its applications. For example, Shorla Oncology's pipeline includes several innovative oncology drugs, which will contribute to the financial growth of the market[3].

Market Outlook

The market outlook for thiotepa is favorable, with several factors contributing to its growth:

• Emerging Trends: The development of new formulations and the increasing focus on precision medicine are emerging trends that will drive the market forward. For instance, the approval of TEPYLUTE addresses unmet needs by simplifying the preparation and administration of thiotepa[3].
• Macro-Economic Factors: The overall economic and political landscapes of countries, along with the social factors influencing healthcare spending, will continue to impact the market. A stable and supportive regulatory environment will be crucial for the market's growth[2].

Key Takeaways

• Growing Demand: The thiotepa market is driven by the increasing incidence of cancers and the need for effective chemotherapeutic agents.
• Advancements in Formulations: New formulations like TEPYLUTE are enhancing the usability and safety of thiotepa administration.
• Competitive Landscape: The market is competitive, with key players investing in research and development to improve thiotepa formulations.
• Positive Financial Trajectory: The market is expected to generate significant revenue by 2031, driven by increasing demand and innovative developments.

FAQs

What is thiotepa used for?

Thiotepa is used in the treatment of various cancers, including blood diseases and solid tumors, particularly in the context of hematopoietic progenitor cell transplantation (HPCT)[1].

What are the common side effects of thiotepa?

Common side effects include infections, cytopenia, graft-versus-host disease, disorders of the gut, haemorrhagic cystitis, and mucosal inflammation[1].

What is TEPYLUTE?

TEPYLUTE is a ready-to-dilute formulation of thiotepa approved by the FDA, designed to simplify preparation and administration, reducing medical personnel exposure to hazardous drugs[3].

Who are the key players in the thiotepa market?

Key players include Shorla Oncology, Heraeus Deutschland GmbH & Co. KG, IDT Australia, MSN Laboratories, Natco Pharma, and Emcure Pharmaceuticals[2][3].

What is the projected growth rate of the thiotepa market?

The market is expected to exhibit a notable CAGR from 2024 to 2031, indicating a sustained and significant expansion[2][4].

Sources

1. European Medicines Agency: Tepadina | European Medicines Agency (EMA) - Europa.eu
2. Market Research Intellect: Global Thiotepa API Market Size, Scope And Forecast Report
3. Biospace: Shorla Oncology Announces FDA Approval for TEPYLUTE, A Novel Formulation to Treat Breast and Ovarian Cancer
4. News Channel Nebraska: Thiotepa Market Size And Analysis Research Report 2032