TEPADINA Drug Patent Profile

When do Tepadina patents expire, and when can generic versions of Tepadina launch?

Tepadina is a drug marketed by Adienne Sa and is included in one NDA.

The generic ingredient in TEPADINA 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 Tepadina

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

Summary for TEPADINA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	32
Patent Applications:	4,100
Drug Prices:	Drug price information for TEPADINA
What excipients (inactive ingredients) are in TEPADINA?	TEPADINA excipients list
DailyMed Link:	TEPADINA at DailyMed

See drug prices for TEPADINA

Recent Clinical Trials for TEPADINA

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 TEPADINA clinical trials

Pharmacology for TEPADINA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

US Patents and Regulatory Information for TEPADINA

TEPADINA is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adienne Sa	TEPADINA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	208264-001	Jan 26, 2017	AP	RX	Yes	Yes
Adienne Sa	TEPADINA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	208264-002	Jan 26, 2017	AP	RX	Yes	Yes

EU/EMA Drug Approvals for TEPADINA

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

TEPADINA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TEPADINA

Introduction

TEPADINA, a formulation of the active substance thiotepa, is a crucial chemotherapeutic agent used in various medical treatments, including conditioning regimens for hematopoietic progenitor cell transplantation (HPCT) and the treatment of several types of cancer. Here, we delve into the market dynamics and financial trajectory of TEPADINA.

Market Size and Projections

The thiotepa market, which includes TEPADINA, has been experiencing significant growth. As of 2023, the global thiotepa market was valued at USD 1.2 billion and is projected to reach USD 2.6 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 9.2% from 2024 to 2031[3].

Key Drivers of Market Growth

Several factors are driving the growth of the thiotepa market:

Increasing Incidence of Cancer

The rising incidence of cancer globally is a major driver. Thiotepa is used in the treatment of various cancers, including breast, ovarian, and bladder cancer, which are becoming more prevalent[3].

Advancements in Oncology Research

Developments in oncology research and the creation of targeted cancer medicines that include thiotepa are expanding its range of applications. This includes its use in conditioning regimens prior to bone marrow transplants[3].

Growing Demand for Chemotherapeutic Drugs

The need for potent chemotherapeutic drugs like thiotepa is increasing due to the growing demand for effective cancer treatments. This demand is further fueled by an aging population and increased healthcare spending[3].

Expansion of Bone Marrow Transplants

The growing usage of bone marrow transplants, which often include thiotepa in their conditioning regimens, is another significant factor contributing to market growth[3].

Market Segmentation

The thiotepa market is segmented based on several criteria:

Type

The market is categorized into thiotepa injection, thiotepa powder, and thiotepa tablets. TEPADINA is available as a powder for solution in single-dose vials for intravenous, intracavitary, or intravesical use[4].

Application

Thiotepa is used in cancer chemotherapy, oncology treatments, and the pharmaceutical industry. Its applications include reducing the risk of graft rejection in HPCT and treating various types of cancer[2][4].

Geographical Regions

The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region has its own growth dynamics driven by local healthcare needs and economic factors[3].

Financial Performance and Availability

FDA Approval and Distribution

TEPADINA was approved by the FDA and is available in the U.S. through Amneal Biosciences in both 15 mg/vial and 100 mg/vial formulations. This approval has made it more convenient for pharmacists to administer larger doses, which is particularly valuable in pediatric transplant processes[4].

Pricing and Accessibility

The availability of TEPADINA in different dosages has improved its accessibility. However, the cost of the drug can be a barrier, especially in developing countries. Rising healthcare spending and easier access to cancer therapies in these regions are helping to drive demand[3].

Safety and Efficacy Considerations

Side Effects and Contraindications

TEPADINA is associated with several side effects, including severe marrow suppression, infections, cytopenia, graft-versus-host disease, and mucosal inflammation. It is contraindicated in patients with severe hypersensitivity to thiotepa and in concomitant use with live or attenuated vaccines[1][2][4].

Risk Management Plan

A risk management plan has been developed to ensure the safe use of TEPADINA. This plan includes safety information in the summary of product characteristics and the package leaflet, outlining precautions for healthcare professionals and patients[1].

Industry Expert Insights

Industry experts highlight the importance of TEPADINA in the treatment of cancer and in conditioning regimens for HPCT. For example, Charles Lucarelli, President of Amneal Biosciences, noted the value of the 100 mg thiotepa vial in accommodating larger doses, which is particularly beneficial in pediatric transplant processes[4].

Market Trends and Future Outlook

The thiotepa market, including TEPADINA, is expected to continue its strong growth trajectory driven by the increasing incidence of cancer, advancements in oncology research, and the growing demand for chemotherapeutic drugs. Here are some key trends:

Increasing Focus on Targeted Therapies

There is a growing focus on targeted cancer therapies, which includes the use of thiotepa in combination with other drugs to enhance efficacy and reduce side effects[3].

Expanding Geographical Reach

The market is expected to expand in various geographical regions, particularly in developing countries where access to cancer therapies is improving[3].

Regulatory Support

Regulatory approvals and support from health authorities, such as the FDA and EMA, are crucial for the continued growth of the thiotepa market[1][4].

Key Takeaways

• The global thiotepa market, including TEPADINA, is projected to grow significantly, reaching USD 2.6 billion by 2031.
• The market is driven by the increasing incidence of cancer, advancements in oncology research, and the growing demand for chemotherapeutic drugs.
• TEPADINA is available in various formulations and is used in conditioning regimens for HPCT and the treatment of several types of cancer.
• The drug is associated with several side effects and has specific contraindications.
• A risk management plan is in place to ensure safe use.

FAQs

What is TEPADINA used for?

TEPADINA is used to reduce the risk of graft rejection in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor cell transplantation (HPCT). It is also used in the treatment of various cancers, including adenocarcinoma of the breast, ovary, and bladder[2][4].

What are the common side effects of TEPADINA?

Common side effects include severe marrow suppression, infections, cytopenia, graft-versus-host disease, mucosal inflammation, and hemorrhagic cystitis[1][2][4].

Can TEPADINA be used in pregnant women?

No, TEPADINA must not be used in women who are pregnant or breast-feeding due to its teratogenic effects observed in animal studies[1][2].

What is the recommended dosage of TEPADINA?

The dosage of TEPADINA varies depending on the type of disease and the patient's body surface area or weight. For example, in adults, the daily dose ranges from 120 to 481 mg/m² given for up to five days before transplantation[1][2].

Is TEPADINA available in different formulations?

Yes, TEPADINA is available as a powder for solution in single-dose vials of 15 mg and 100 mg for intravenous, intracavitary, or intravesical use[4].

What is the market size and growth projection for the thiotepa market?

The global thiotepa market was valued at USD 1.2 billion in 2023 and is expected to reach USD 2.6 billion by 2031, growing at a CAGR of 9.2% from 2024 to 2031[3].

Sources

1. European Medicines Agency - Tepadina | European Medicines Agency (EMA) - Europa.eu
2. FDA - TEPADINA [PDF] - accessdata.fda.gov
3. Market Research Intellect - Thiotepa Market Size and Projections - Market Research Intellect
4. BioSpace - First FDA-Approved 100 Mg Thiotepa Now Available ... - BioSpace