Melphalan hydrochloride - Generic Drug Details

What are the generic sources for melphalan hydrochloride and what is the scope of freedom to operate?

Melphalan hydrochloride is the generic ingredient in five branded drugs marketed by Apotex, Actavis Llc, Almaject, Arthur Grp, Avet Lifesciences, Bpi Labs, Dr Reddys, Fresenius Kabi Usa, Gland, Hetero Labs, Hikma, Meitheal, Mylan Institutional, Novast Labs, Ph Health, Sagent Pharms Inc, Uswm, Delcath Systems Inc, and Acrotech Biopharma, and is included in twenty-two NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Melphalan hydrochloride has one hundred and thirty-two patent family members in twenty-six countries.

There are nine drug master file entries for melphalan hydrochloride. Seventeen suppliers are listed for this compound.

Summary for melphalan hydrochloride

International Patents:	132
US Patents:	18
Tradenames:	5
Applicants:	19
NDAs:	22
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	901
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for melphalan hydrochloride
What excipients (inactive ingredients) are in melphalan hydrochloride?	melphalan hydrochloride excipients list
DailyMed Link:	melphalan hydrochloride at DailyMed

Recent Clinical Trials for melphalan hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Vastra Gotaland Region	PHASE1
St. Jude Children's Research Hospital	PHASE1
Janssen Research & Development, LLC	PHASE2

See all melphalan hydrochloride clinical trials

Pharmacology for melphalan hydrochloride

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for melphalan hydrochloride

L01AA	Nitrogen mustard analogues
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for MELPHALAN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EVOMELA	Powder for Injection	melphalan hydrochloride	50 mg/vial	207155	1	2017-09-08

US Patents and Regulatory Information for melphalan hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Institutional	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	090270-001	Jun 9, 2009	AP	RX	No	Yes
Novast Labs	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	210947-001	Feb 18, 2020		DISCN	No	No
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes	10,098,997		Y
Hikma	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	090303-001	Oct 28, 2010	AP	RX	No	No
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes	10,195,334		Y
Fresenius Kabi Usa	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	203393-001	Dec 22, 2017	AP	RX	No	No

Expired US Patents for melphalan hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	ALKERAN	melphalan hydrochloride	INJECTABLE;INJECTION	020207-001	Nov 18, 1992	4,997,651

International Patents for melphalan hydrochloride

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201000828
European Patent Office	3603693	FILTRE ET APPAREIL CADRE ET PROCÉDÉ D'UTILISATION (FILTER AND FRAME APPARATUS AND METHOD OF USE)
European Patent Office	2434886	COMPOSITIONS INJECTABLES À BASE DE MELPHALAN COMPRENANT UN DÉRIVÉ DE CYCLODEXTRINE ET LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (INJECTABLE MELPHALAN COMPOSITIONS COMPRISING A CYCLODEXTRIN DERIVATIVE AND METHODS OF MAKING AND USING THE SAME)
Canada	2763365
Eurasian Patent Organization	201892508	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ
New Zealand	596515

Supplementary Protection Certificates for melphalan hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	CA 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	122023000007	Germany		PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
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	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

Market Dynamics and Financial Trajectory for Melphalan Hydrochloride

Last updated: July 28, 2025

Introduction

Melphalan hydrochloride is an alkylating chemotherapeutic agent primarily utilized in the treatment of multiple myeloma and ovarian cancer. As a cornerstone in chemotherapy regimens, its market dynamics are driven by clinical efficacy, regulatory pathways, manufacturing intricacies, and emerging treatment paradigms. This report analyzes the current market landscape, key drivers, challenges, and the financial trajectory anticipated for melphalan hydrochloride over the coming years.

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Market Overview and Regulatory Landscape

Melphalan hydrochloride, marketed under various brand names worldwide, has maintained its significance in oncology. Despite the advent of newer agents, it remains vital, especially in high-dose chemotherapy protocols coupled with stem cell transplantation. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have historically approved formulations based on established efficacy and safety profiles. However, patent expirations and generic availability have influenced pricing strategies and market competition.

In recent years, regulatory pathways for biosimilars and generics have accelerated market penetration, impacting pricing and profit margins. For instance, the approval of generic melphalan formulations in the United States following patent expiry diminished barriers to market entry for low-cost competitors.

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Key Market Drivers

1. Rising Prevalence of Multiple Myeloma and Ovarian Cancer

According to the Global Cancer Observatory, multiple myeloma incidence increases globally, with an aging population contributing substantially to demand. Ovarian cancer remains a leading gynecological malignancy, necessitating effective chemotherapeutic options such as melphalan. The growing patient base sustains steady demand.

2. Integration in High-Dose Chemotherapy Regimens

Melphalan is integral to high-dose chemotherapy (HDCT) and stem cell transplants for multiple myeloma, particularly in transplant conditioning regimens. The optimization of these protocols sustains its clinical relevance and market share.

3. Expansion into Developing Markets

Emerging economies exhibit increased adoption of established chemotherapeutics driven by improving healthcare infrastructure and rising cancer incidence rates. This expansion fuels market growth, especially for cost-effective generic formulations.

4. Technological Advances in Drug Manufacturing

Innovations in synthesis and formulation processes have enhanced the quality, stability, and bioavailability of melphalan hydrochloride. These advances reduce production costs, facilitating competitive pricing and wider accessibility.

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Market Challenges and Limitations

1. Competition from Newer Therapeutics

Targeted therapies, monoclonal antibodies, and immunotherapies are gradually supplanting traditional alkylating agents in some indications. Although melphalan remains standard in specific regimens, its market share faces pressure.

2. Regulatory and Safety Concerns

Potential safety issues, such as secondary malignancies and toxicity profiles, necessitate vigilant regulation and may influence prescribing patterns. Regulatory updates can impact market dynamics, especially if new safety data emerge.

3. Patent Expiry and Price Erosion

Patent expiration accelerates generic entry, lowering prices and compressing profit margins for branded formulations. Price competition significantly influences sales volumes.

4. Supply Chain Disruptions

Manufacturing complexities, especially for sterile injectables, heighten vulnerability to supply disruptions, impacting availability and revenue streams.

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Financial Trajectory and Market Forecast

Current Market Size

The global chemotherapy agents market was valued at approximately $20-25 billion in 2022, with alkylating agents like melphalan representing a significant segment. Melphalan's contribution is estimated at $1-1.5 billion, reflecting its use predominantly in multiple myeloma and ovarian cancer treatments. Its sales are concentrated in North America, Europe, and Asia-Pacific.

Market Growth Projections

The market is projected to grow at a compound annual growth rate (CAGR) of 3-5% during 2023-2030. This growth is driven by the increasing cancer burden, expanding indications, and wider adoption in emerging markets. The increasing preference for combination regimens incorporating melphalan, along with high-dose protocols, augments demand.

Impact of Generic Competition

Patent expirations in major markets, notably the United States and Europe, are expected to intensify competition from generics, resulting in price erosion of 20-30% annually post-entry. This will exert pressure on revenue but also broaden access, potentially increasing overall sales volume.

Potential for Biosimilar and New Formulations

While biosimilars are less applicable to small-molecule chemotherapies like melphalan, reformulations such as liposomal or extended-release variants could rejuvenate the market. Currently, no such formulations are on the horizon, but ongoing research into drug delivery systems may influence future trajectories.

Regulatory and Reimbursement Dynamics

Reimbursement policies and pricing controls in different regions will substantially impact profitability. Countries with reforms favoring biosimilar and generic utilization will see downward pricing pressure, whereas regions maintaining more flexible policies may sustain higher margins.

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Emerging Trends and Strategic Considerations

• Adoption of combinatorial regimens with novel agents could sustain or expand market relevance.
• Manufacturing innovations reducing costs could stabilize profit margins amidst generic competition.
• Market expansion into underserved geographies will drive volume growth.
• Investments in research exploring new indications or delivery methods for melphalan could unlock additional revenue streams.

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Key Takeaways

• Stable Demand in Specific Oncology Modalities: Melphalan hydrochloride remains essential in high-dose chemotherapy protocols, particularly for multiple myeloma, with steady demand underpinning its market position.
• Impact of Patent Expiry and Generics: Expiration of patents leads to increased generic competition, compressing prices but expanding access and sales volume.
• Market Growth Led by Emerging Economies: Rising cancer incidence and improved healthcare infrastructure in developing regions create growth opportunities.
• Competitive Landscape Shaping: New therapies and evolving treatment guidelines may gradually influence market share, demanding strategic adaptation.
• Financial Outlook: The overall market is expected to see moderate growth, with revenue stability maintained through volume expansion and cost-effective manufacturing.

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Conclusion

The landscape for melphalan hydrochloride is characterized by a balance between enduring clinical efficacy, market competition from generics, and shifting oncological treatment paradigms. While revenue growth may decelerate owing to price erosion and competitive dynamics, stable demand driven by established efficacy in high-dose chemotherapy approaches supports a positive financial trajectory. To capitalize on future opportunities, stakeholders should focus on expanding access in emerging markets, leveraging manufacturing efficiencies, and monitoring developments in alternative therapies that may influence its application.

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FAQs

1. What are the main indications for melphalan hydrochloride?
Primarily, melphalan is used in the treatment of multiple myeloma, ovarian cancer, and as part of high-dose chemotherapy regimens preceding stem cell transplantation.

2. How does patent expiry affect the market for melphalan hydrochloride?
Patent expiry enables generic manufacturers to produce lower-cost versions, increasing competition, reducing prices, and potentially lowering revenue margins for branded formulations.

3. Are there any new formulations of melphalan under development?
Currently, no novel formulations are approved; however, research into liposomal or sustained-release versions is ongoing, which may influence future market dynamics.

4. How significant is emerging market growth for melphalan sales?
Emerging markets present substantial opportunities due to rising cancer incidence, improving healthcare access, and affordability of generics, supporting volume growth.

5. What are the main challenges facing melphalan's market sustainability?
Key challenges include competition from targeted and immunotherapies, safety concerns, regulatory changes, and economic pressures from price erosion post-patent expiry.

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Sources:
[1] Global Cancer Observatory, International Agency for Research on Cancer.
[2] MarketResearch.com. "Global Chemotherapy Agents Market Outlook."
[3] FDA Drug Approvals and Regulatory Updates.
[4] IQVIA Data, 2022 Market Insights.
[5] Recent Clinical Trials and Oncology Guidelines, 2022-2023.