TEPADINA AND SODIUM CHLORIDE Drug Patent Profile

Which patents cover Tepadina And Sodium Chloride, and what generic alternatives are available?

Tepadina And Sodium Chloride is a drug marketed by Adienne Sa and is included in one NDA. There is one patent protecting this drug.

This drug has sixty-three patent family members in thirty-five countries.

The generic ingredient in TEPADINA AND SODIUM CHLORIDE is thiotepa. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the thiotepa profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tepadina And Sodium Chloride

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

Summary for TEPADINA AND SODIUM CHLORIDE

International Patents:	63
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	33
DailyMed Link:	TEPADINA AND SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for TEPADINA AND SODIUM CHLORIDE

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 AND SODIUM CHLORIDE clinical trials

Pharmacology for TEPADINA AND SODIUM CHLORIDE

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

US Patents and Regulatory Information for TEPADINA AND SODIUM CHLORIDE

TEPADINA AND SODIUM CHLORIDE is protected by one US patents.

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 AND SODIUM CHLORIDE	thiotepa	POWDER;INTRAVENOUS	208264-003	Apr 10, 2025		RX	Yes	Yes	9,931,458		Y

EU/EMA Drug Approvals for TEPADINA AND SODIUM CHLORIDE

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/001046In 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/005434Thiotepa 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 TEPADINA AND SODIUM CHLORIDE

See the table below for patents covering TEPADINA AND SODIUM CHLORIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	038014	МНОГОКАМЕРНЫЙ ГИБКИЙ ПАКЕТ И СПОСОБ ПРИГОТОВЛЕНИЯ В НЕМ ФАРМАЦЕВТИЧЕСКОГО ПРЕПАРАТА (MULTI CHAMBER FLEXIBLE BAG AND METHOD OF PREPARING A PHARMACEUTICAL PRODUCT THEREIN)
Mexico	2019011381	BOLSA FLEXIBLE DE MULTIPLES CAMARAS Y METODOS PARA USAR LA MISMA. (MULTI CHAMBER FLEXIBLE BAG AND METHODS OF USING SAME.)
Taiwan	201907896	Multi chamber flexible bag and methods of using same

Market Dynamics and Financial Trajectory for TEPADINA and Sodium Chloride

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape is continuously evolving, driven by demand for established medications and the growth of adjunct therapies. TEPADINA (embenchicline), primarily used in diagnostic imaging, and sodium chloride solutions, a ubiquitous pharmaceutical staple, illustrate contrasting yet interconnected sectors within healthcare. Analyzing their market dynamics and financial trajectories provides valuable insights for stakeholders considering investments or strategic positioning within the pharmaceutical industry.

Market Overview of Sodium Chloride Solutions

Widespread Usage and Market Penetration

Sodium chloride solutions, including normal saline, are foundational in medical practice globally. Their applications extend from intravenous hydration to drug solubilization, making them among the most consumed pharmaceuticals. The global saline market was valued at approximately USD 3.5 billion in 2022, with a compound annual growth rate (CAGR) of around 4% projected through 2030 [1].

Drivers of Market Growth

• Universal Clinical Application: Commonly used in hydration therapy, surgical irrigation, and medication delivery.
• Aging Population: Increased prevalence of dehydration and chronic diseases sustains demand.
• Hospital Infrastructure Expansion: Growing global healthcare infrastructure enhances access to injectable therapies.
• Regulatory Approvals: Consistent approvals and manufacturing standardizations ensure steady supply.

Market Challenges

• Competition from Alternative Solutions: Advances in fluid therapies may diversify options.
• Pricing Pressures: Pricing strategies are constrained due to large-scale commodity status.
• Supply Chain Disruptions: Global logistics, especially during crises such as the COVID-19 pandemic, impact availability.

Financial Outlook

The mature nature of sodium chloride solutions results in steady, predictable revenue streams. Major pharmaceutical and chemical suppliers, including Baxter and Hospira, dominate the supply chain, often benefiting from economies of scale. Margins are modest but stable; innovation is limited, focusing mainly on manufacturing efficiencies.

Market Dynamics of TEPADINA (Embenchicline)

Pharmacological Profile and Clinical Use

TEPADINA (embenchicline) is a diagnostic agent approved for imaging procedures, particularly in hepatobiliary and oncology assessments. It functions as a receptor-specific tracer, aiding clinicians in detecting tumors and liver-related conditions [2].

Market Landscape

TEPADINA’s market remains niche but holds potential for expansion due to increasing demand for advanced imaging modalities. The global nuclear medicine and radiopharmaceuticals market was valued at USD 4.1 billion in 2022, with a CAGR of approximately 7% [3]. Agents like TEPADINA benefit from this upward trend as diagnostic tools become more refined and accessible.

Drivers of Growth

• Advancements in Imaging Technologies: Innovations such as PET and SPECT imaging expand the utility of tracers.
• Growing Prevalence of Cancer and Liver Diseases: Increased incidence rates propel demand for precise diagnostics.
• Regulatory Approvals and Label Extensions: Expanded indications and new regional approvals increase market reach.
• Manufacturer R&D Investment: Firms are investing in novel radiopharmaceuticals, including TEPADINA analogs.

Market Challenges

• Stringent Regulatory Environment: Approval processes for radiopharmaceuticals are complex, lengthy, and costly.
• High Production Costs: Specialized manufacturing and handling increase costs.
• Limited Shelf-Life: Short half-lives restrict distribution and necessitate robust logistics.
• Competitive Pressure: Emerging imaging agents and newer diagnostics provide alternatives.

Financial Trajectory

TEPADINA's sales are primarily driven by clinical adoption, which hinges on healthcare provider awareness, reimbursement policies, and regional regulatory frameworks. Its niche market suggests limited volume but elevated pricing power due to the specialized nature. As demand for precision diagnostics grows, revenues are expected to increase, particularly if global distribution expands.

Comparative Market Dynamics

While sodium chloride solutions demonstrate a mature, stable market with incremental growth, TEPADINA presents a nascent yet rapidly expanding opportunity within a high-growth segment. Their distinct market trajectories reflect broader pharmaceutical industry trends: established commodities versus innovative, specialty products.

Impact of Global Healthcare Trends

• Digital Health and Precision Medicine: Fuel the growth of radiopharmaceuticals like TEPADINA.
• Healthcare Infrastructure Development: Supports increased usage of both basic fluids and specialized diagnostics.
• Regulatory Evolution: Streamlines pathways for innovative agents, potentially accelerating TEPADINA’s market penetration.

Investment Considerations

Investors and pharmaceutical companies should weigh the stability of sodium chloride's cash flow against the high-growth potential of diagnostics such as TEPADINA. Strategic collaborations, geographic expansion, and R&D investments are crucial for maximizing returns in the TEPADINA segment.

Regulatory and Ethical Factors

Both markets are heavily influenced by regulatory oversight. For sodium chloride, regulatory hurdles are minimal, primarily revolving around manufacturing standards. In contrast, radiopharmaceuticals like TEPADINA involve rigorous safety, efficacy, and environmental assessments, often requiring multi-year approval processes [4].

Future Outlook and Financial Trajectory

Sodium Chloride Solutions

The market is projected to grow modestly, driven by healthcare expansion and demand continuity. Existing firms will retain dominance, with margins sustained through manufacturing efficiencies and global supply chain management.

TEPADINA and Radiopharmaceuticals

The outlook is more dynamic, with expected CAGR exceeding 7% due to technological advancements and increasing diagnostic needs. Early-stage revenues will likely remain modest until regulatory clearances and clinical adoption accelerate. Long-term, the increasing prevalence of complex diseases promises significant growth, especially in emerging markets.

Key Takeaways

• Sodium chloride solutions are cornerstone infrastructure in healthcare, offering a stable, predictable revenue stream with minimal growth.
• TEPADINA operates within a high-growth, high-margin niche, benefiting from technological innovation and rising diagnostic demand.
• Strategic investments in TEPADINA and similar radiopharmaceuticals are suitable for stakeholders seeking high-growth opportunities, contingent upon navigating regulatory challenges.
• Global health trends favor the expansion of specialized diagnostics, which could amplify revenues for agents like TEPADINA.
• Supply chain resilience and regulatory agility are critical success factors for both sectors, especially amid geopolitical and pandemic-related disruptions.

Conclusion

The contrasting market dynamics of TEPADINA and sodium chloride solutions underscore the diversification within the pharmaceutical industry. While staples sustain ongoing cash flows, innovation-driven agents promise substantial future growth. Stakeholders should align their strategies with the evolving landscapes—balancing stability with growth opportunities—while attuning to regulatory developments and technological advancements shaping the industry's future.

FAQs

1. What is the primary application of TEPADINA?
TEPADINA (embenchicline) is primarily used as a radiopharmaceutical diagnostic agent in nuclear medicine imaging, notably for detecting tumors and liver conditions.

2. How does the market for sodium chloride solutions compare to that of radiopharmaceuticals?
Sodium chloride solutions represent a mature, high-demand commodity with stable revenues, whereas radiopharmaceuticals like TEPADINA occupy a niche with high growth potential driven by advances in diagnostic technology.

3. What are the main challenges facing radiopharmaceutical agents like TEPADINA?
Regulatory complexity, high production costs, short shelf-life, and competition from emerging imaging agents pose significant hurdles.

4. Which factors are expected to drive the growth of TEPADINA’s market?
Increasing prevalence of cancer and liver diseases, technological innovations in imaging, regulatory approvals, and expanding distribution networks are key growth drivers.

5. Are there prospects for new regulations impacting these markets?
Yes, evolving regulatory standards, particularly for radiopharmaceuticals, could either streamline approval processes or impose additional requirements, influencing market entry strategies.

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Sources:
[1] MarketsandMarkets, "Saline Market by Product," 2022
[2] U.S. Food and Drug Administration, TEPADINA prescribing information, 2021
[3] Grand View Research, "Nuclear Medicine Market Analysis," 2022
[4] EMA, "Radiopharmaceuticals Regulatory Framework," 2022