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
Hungary	E046954
Finland	3590561
European Patent Office	2797644	APPAREIL FILTRANT ET CADRE, ET PROCÉDÉ D'UTILISATION (FILTER AND FRAME APPARATUS AND METHOD OF USE)
Spain	2950585
European Patent Office	3360588	FILTRE ET APPAREIL CADRE ET PROCÉDÉ D'UTILISATION (FILTER AND FRAME APPARATUS AND METHOD OF USE)
World Intellectual Property Organization (WIPO)	2013070809
Spain	2757557

Supplementary Protection Certificates for HEPZATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	CR 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 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
2701720	CA 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	122023000007	Germany		PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
2701720	3/2023	Austria		PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818

HEPZATO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HEPZATO

Introduction

HEPZATO, a drug developed by Delcath Systems, is making significant strides in the treatment of various cancers, particularly in liver-dominant metastatic diseases. Here, we will delve into the market dynamics and financial trajectory of HEPZATO, highlighting its current status, future prospects, and the implications for investors and patients.

FDA Clearance and Clinical Trials

Delcath Systems has recently received FDA clearance for its Investigational New Drug (IND) application to conduct a Phase 2 clinical trial of HEPZATO in liver-dominant metastatic colorectal cancer (mCRC). This trial will enroll approximately 90 patients across more than 20 sites in the US and Europe, evaluating HEPZATO combined with standard care versus standard care alone. The trial's design and international scope indicate a robust approach to assessing the drug's efficacy and safety[1].

Market Opportunity

The target market for HEPZATO in liver-dominant mCRC is substantial, with an estimated 6,000 to 10,000 patients annually in the US alone receiving third-line treatment. This market size presents a significant opportunity for Delcath Systems to expand its revenue streams beyond its current focus on metastatic uveal melanoma[1].

Current Market Adoption

HEPZATO has already shown strong market adoption in the treatment of uveal melanoma patients with liver metastases. In the third quarter of 2024, HEPZATO KIT generated $10 million in U.S. sales, demonstrating rapid uptake by physicians. This adoption is a positive indicator of the unmet medical need HEPZATO addresses and its potential for broader market acceptance[3][5].

Financial Performance

Delcath Systems reported total revenue of $11.2 million for the third quarter of 2024, a 44% increase from the previous quarter. This revenue includes $10 million from HEPZATO KIT and $1.2 million from CHEMOSAT. The company's financial position has improved significantly with the exercise of Tranche B warrants, resulting in approximately $25 million in proceeds. This additional capital will support ongoing commercialization efforts and fund new clinical trials for expanded indications in 2025[3][5].

Cash Position and Debt

As of the third quarter of 2024, Delcath Systems had a cash and investments position of $14 million, with a quarterly cash burn of $3.6 million. The company has also cleared all its debt obligations, further stabilizing its financial health. This financial stability is crucial for maintaining shareholder value and supporting the ongoing development and commercialization of HEPZATO[4][5].

Research and Development Expenses

Research and development expenses for Delcath Systems decreased to $3.9 million in the third quarter of 2024, down from $4.7 million in the previous year. This reduction, combined with increased selling, general, and administrative expenses due to commercial launch activities, reflects the company's strategic allocation of resources to drive market penetration and clinical trial advancements[5].

Clinical Trial Outcomes and Future Prospects

The CHOPIN study, an investigator-initiated trial evaluating the sequencing of immunotherapy with CHEMOSAT liver-directed therapy, is fully enrolled with 76 patients. Additionally, subgroup analyses from the FOCUS Phase 3 trial presented at ESMO 2024 showed similar outcomes in overall survival, overall response rate, and progression-free survival between different patient groups. These positive outcomes support the continued use and expansion of HEPZATO in various indications[4].

Market Expansion and Revenue Growth

The $25 million financing from warrant exercises will be instrumental in supporting the commercial launch and investment in new clinical trials for expanded indications. Delcath Systems plans to activate more treatment centers, with twelve already active and several more in the process of preceptorship training. This expansion strategy is expected to drive revenue growth and broaden the market reach of HEPZATO[3][4].

Investor Perspective

For investors, the long-term potential of HEPZATO is promising. The drug's efficacy in a larger market like colorectal cancer could significantly boost Delcath Systems' market cap, currently at $379 million. However, investors should view this as a long-term value driver rather than a near-term catalyst, given the trial timelines extending to 2027-2028[1].

Key Takeaways

• FDA Clearance: HEPZATO has received FDA clearance for a Phase 2 trial in liver-dominant mCRC.
• Market Opportunity: The target market for HEPZATO in mCRC is substantial, with 6,000-10,000 patients annually in the US.
• Financial Performance: Strong revenue growth, with $10 million in U.S. sales for HEPZATO KIT in Q3 2024.
• Cash Position: Improved financial health with $14 million in cash and investments and no outstanding debt.
• Clinical Trials: Positive outcomes from ongoing and completed trials support the drug's efficacy and safety.
• Market Expansion: Plans to activate more treatment centers and invest in new clinical trials for expanded indications.

FAQs

Q: What is the current status of HEPZATO's clinical trials? A: HEPZATO has received FDA clearance for a Phase 2 clinical trial in liver-dominant metastatic colorectal cancer, with patient enrollment expected to start in H2 2025.

Q: How significant is the market opportunity for HEPZATO in mCRC? A: The target market for HEPZATO in liver-dominant mCRC includes 6,000 to 10,000 patients annually in the US, presenting a substantial market opportunity.

Q: What are the financial highlights for Delcath Systems in Q3 2024? A: Delcath Systems reported $11.2 million in total revenue, with $10 million from HEPZATO KIT, and received approximately $25 million from warrant exercises.

Q: How is Delcath Systems' cash position and debt status? A: As of Q3 2024, Delcath Systems had $14 million in cash and investments and had cleared all its debt obligations.

Q: What are the future prospects for HEPZATO? A: HEPZATO is expected to drive revenue growth through market expansion, activation of more treatment centers, and investment in new clinical trials for expanded indications.

Sources

1. Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Colorectal Cancer - Stock Titan
2. Delcath Systems Reports Second Quarter 2023 Results and Provides Business Update - Delcath Systems
3. Delcath Systems Announces Preliminary Third Quarter 2024 Revenue Results - Stock Titan
4. Delcath Systems Reports Third Quarter 2024 Results and Business Highlights - Delcath Systems
5. Delcath Systems Reports Third Quarter 2024 Results and Business Highlights - Stock Titan