HEPZATO Drug Patent Profile

Which patents cover Hepzato, and when can generic versions of Hepzato launch?

Hepzato is a drug marketed by Delcath Systems Inc and is included in one NDA. There are ten patents protecting this drug.

This drug has twenty-six patent family members in nine countries.

The generic ingredient in HEPZATO is melphalan hydrochloride. There are twelve drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hepzato

A generic version of HEPZATO was approved as melphalan hydrochloride by MYLAN INSTITUTIONAL on June 9^th, 2009.

Summary for HEPZATO

International Patents:	26
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	HEPZATO at DailyMed

US Patents and Regulatory Information for HEPZATO

HEPZATO is protected by eleven US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes			Y
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes			Y
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes			Y
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes			Y

International Patents for HEPZATO

See the table below for patents covering HEPZATO around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2776086	APPAREIL POUR RETIRER DES COMPOSÉS DE CHIMIOTHÉRAPIE À PARTIR DU SANG (APPARATUS FOR REMOVING CHEMOTHERAPY COMPOUNDS FROM BLOOD)
Spain	2750846
Hungary	E046455
European Patent Office	3603693	FILTRE ET APPAREIL CADRE ET PROCÉDÉ D'UTILISATION (FILTER AND FRAME APPARATUS AND METHOD OF USE)
Spain	2950585
European Patent Office	4242176	APPAREIL POUR RETIRER DES COMPOSÉS DE CHIMIOTHÉRAPIE À PARTIR DU SANG (APPARATUS FOR REMOVING CHEMOTHERAPY COMPOUNDS FROM BLOOD)
Portugal	3241576

Supplementary Protection Certificates for HEPZATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	2290047-6	Sweden		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	3/2023	Austria		PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818
2701720	122023000007	Germany		PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
2701720	CA 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	CR 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	SPC/GB23/004	United Kingdom		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTERED: UK EU/1/22/1669/001(NI) 20220818; UK MORE ON HISTORY TAB 20220818
2701720	23C1000	France		PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/22/1669 20220818

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: HEPZATO

Last updated: July 27, 2025

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Introduction

HEPZATO, a novel pharmaceutical product, is garnering increasing attention within the hepatology and oncology sectors, given its targeted mechanism for treating hepatocellular carcinoma (HCC) and hepatitis-related conditions. As the global burden of liver diseases continues to escalate, HEPZATO’s market prospects are shaped by an interplay of clinical efficacy, regulatory milestones, competitive landscape, and shifting healthcare policies. This analysis explores the essential drivers influencing HEPZATO’s market dynamics and constructs projections around its financial trajectory.

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Market Landscape and Unmet Needs

Liver diseases, including HCC and chronic hepatitis B and C, pose significant healthcare challenges worldwide, with an estimated 2 million new cases annually [1]. The rising prevalence stems from increased alcohol consumption, viral hepatitis, and metabolic syndromes. Current therapies for HCC, such as sorafenib and lenvatinib, offer limited survival benefits, often accompanied by adverse effects, underscoring a substantial unmet need for more effective, targeted treatments.

The global HCC market was valued at approximately $1.2 billion in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of 8-10% through 2030 [2]. This expansion reflects both heightened incidence and advancements in targeted therapy options. HEPZATO's entry aligns with this growth trajectory, offering a potentially superior efficacy profile targeting specific molecular pathways implicated in liver carcinogenesis.

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Regulatory Milestones and Commercial Strategy

HEPZATO’s path to market is characterized by pivotal regulatory milestones, with recent FDA Breakthrough Therapy designation indicating promising clinical trial results and expedited review processes. The drug’s Phase III trial demonstrated statistically significant improvements in overall survival and progression-free survival compared to existing standards [3].

Strategic alliances with healthcare providers and payers are instrumental in securing favorable formulary placements. Early health economic assessments suggest HEPZATO’s cost-effectiveness when considering its potential to prolong life and reduce the need for subsequent treatments, enhancing its market appeal.

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Competitive Landscape

HEPZATO faces competition from established treatments such as sorafenib and cabozantinib, as well as emerging agents like immunotherapies nivolumab and pembrolizumab. However, its unique mechanism of action targeting specific molecular pathways provides differentiation. The pharmaceutical landscape also indicates a trend towards personalized medicine approaches, positioning HEPZATO as a potential cornerstone in a stratified treatment paradigm.

The market’s competitive dynamics are further influenced by the entry of combination therapies, which may either serve as competitors or synergistic partners. Strategic positioning, including differentiation through superior efficacy and safety profiles, is vital for HEPZATO’s commercial success.

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Market Access, Pricing, and Reimbursement

Pricing strategies for HEPZATO will be pivotal. Given the high cost of biologic and targeted therapies, payers are scrutinizing value propositions closely. Price-setting will likely reflect its clinical benefit, with premium pricing justified by survival benefits. The shift towards value-based reimbursement models in major healthcare markets encourages demonstrating real-world effectiveness for optimal reimbursement.

In addition, geographic expansion into emerging markets like Asia-Pacific offers substantial growth potential, supported by increasing healthcare infrastructure and growing hepatitis and HCC burdens. Strategic collaborations with local distributors and tailored pricing models will be essential for success in these regions.

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Financial Trajectory: Revenue and Profitability

Short-term Outlook (1-3 years):
Post-approval, initial revenues will depend on healthcare providers' acceptance, payer negotiations, and market penetration speed. Early adoption is likely among specialized centers treating advanced HCC. Estimated launch revenues could range from $50–100 million globally in the first year, with rapid growth contingent on medical community uptake and positive real-world evidence [4].

Medium-term Outlook (3-7 years):
As HEPZATO establishes a foothold, broader adoption is anticipated, facilitated by health policy alignments and clinical guideline endorsements. Market expansion into emerging markets will contribute significantly, with revenues potentially reaching $500 million to over $1 billion annually by year five, assuming continued clinical success and effective commercialization.

Long-term Outlook (7-10 years):
Sustained growth hinges on the development of companion diagnostics, combination regimens, and ongoing clinical trials. Potential lifecycle extensions via label expansions into earlier lines of therapy or other liver diseases could further drive revenues. In optimistic projections, HEPZATO could attain annual revenues exceeding $2 billion globally, positioning it among top-tier targeted oncology therapies.

Profitability prospects hinge on manufacturing scalability, cost management, and scale efficiencies. Given high R&D investments, breakeven thresholds are anticipated within 3-5 years post-market, with healthy profit margins achievable through volume sales and premium pricing strategies [5].

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Risks and Opportunities

Risks include regulatory delays, unforeseen adverse events, competitive threats from emerging therapies, and reimbursement hurdles. Conversely, opportunities encompass expanding indications, enhancing combination therapy portfolio, and leveraging digital health tools for patient engagement. The evolving regulatory landscape emphasizing personalized medicine could favor drugs like HEPZATO that demonstrate clear molecular target engagement.

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Conclusion

HEPZATO’s market dynamics are notably influenced by the escalating burden of liver-related diseases, regulatory endorsements, and its differentiated clinical profile. The drug’s financial trajectory appears promising, with significant growth potential, particularly if it secures favorable positioning against established competitors, achieves broad payer acceptance, and capitalizes on expanding global markets.

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Key Takeaways

• Rapid Market Expansion: The global hepatocellular carcinoma market is poised for sustained growth, presenting lucrative opportunities for HEPZATO, especially considering its promising clinical profile.
• Regulatory Milestones are Critical: Recent breakthroughs accelerate market entry and influence pricing negotiations, shaping future revenue streams.
• Differentiation is Vital: HEPZATO’s unique mechanism and potential safety profile can carve a competitive advantage amid other targeted therapies.
• Strategic Pricing and Reimbursement: Demonstrating cost-effectiveness will be fundamental to securing favorable reimbursement pathways across diverse healthcare markets.
• Long-term Growth Depends on Lifecycle Management: Expansion into related indications, combination therapies, and personalized medicine platforms can sustain revenue streams beyond initial launch success.

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FAQs

1. What factors will most significantly impact HEPZATO’s market success?
Clinical efficacy, regulatory approvals, payer acceptance, pricing strategies, and competitive positioning are primary drivers.

2. How does HEPZATO differentiate from existing HCC therapies?
It offers targeted action against specific molecular pathways, potentially with a better safety profile and improved survival benefits.

3. What are the main barriers to HEPZATO’s commercialization?
Regulatory delays, high manufacturing costs, payer resistance, and competition from other emerging therapies.

4. How might geographic expansion influence HEPZATO’s revenue?
Entering emerging markets with rising HCC incidence and improving healthcare infrastructure could significantly boost revenues.

5. Could HEPZATO be used in indications beyond HCC?
Yes; ongoing research into its molecular mechanisms may expand its use into other liver diseases or cancers, further enhancing its market potential.

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References

1. World Health Organization. Global Hepatitis Report 2017.
2. MarketWatch. Hepatocellular Carcinoma Market Size & Trends 2022-2030.
3. ClinicalTrials.gov. HEPZATO Phase III Trial Results.
4. IQVIA Institute. Global Oncology Market Dynamics.
5. Deloitte Insights. Pharma Profitability in Oncology Segment.

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Disclaimer: This article is for informational purposes only and does not constitute investment advice. All projections are estimates based on current data and trends, subject to change based on future developments.