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, Endo Operations, Fresenius Kabi Usa, Gland, Hetero Labs, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, 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 twenty-nine patent family members in twenty-six countries.

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

Summary for melphalan hydrochloride

International Patents:	129
US Patents:	18
Tradenames:	5
Applicants:	19
NDAs:	22
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	869
Patent Applications:	2,491
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
St. Louis Children's Hospital Foundation	Phase 1/Phase 2
Rising Tide Foundation	Phase 1/Phase 2
The Leukemia and Lymphoma Society	Phase 1/Phase 2

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	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
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes	11,083,831		Y
Fresenius Kabi Usa	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	203393-001	Dec 22, 2017	AP	RX	No	No
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	9,493,582		Y
Actavis Llc	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	POWDER;INTRAVENOUS	209323-001	Mar 6, 2020		DISCN	No	No
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	9,200,088		Y

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
Mexico	360192	COMPOSICIONES DE CICLODEXTRINAS ALQUILADAS Y PROCESOS PARA PREPARAR Y USAR LAS MISMAS. (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME.)
China	101959508	Sulfoalkyl ether cyclodextrin compositions
World Intellectual Property Organization (WIPO)	2013130666
China	105073785	Alkylated cyclodextrin compositions and processes for preparing and using the same
Canada	2702603	COMPOSITIONS DE CYCLODEXTRINE A GROUPEMENTS ETHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Mexico	2010004900	COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)

Supplementary Protection Certificates for melphalan hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
2701720	CR 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. 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

Market Dynamics and Financial Trajectory for Melphalan Hydrochloride

Last updated: July 5, 2025

Introduction to Melphalan Hydrochloride

Melphalan hydrochloride, a cornerstone alkylating agent in oncology, has played a pivotal role in treating multiple myeloma and ovarian cancer since its approval in the 1950s. As a generic version of the original melphalan, this drug disrupts cancer cell DNA, offering clinicians a reliable option in chemotherapy regimens. In today's pharmaceutical landscape, understanding its market dynamics and financial trajectory helps stakeholders navigate pricing pressures, patent expirations, and evolving demand patterns. This analysis delves into how these factors shape the drug's commercial viability, providing actionable insights for investors and executives.

Overview of Market Dynamics

The market for melphalan hydrochloride reflects broader trends in oncology pharmaceuticals, where generic competition and regulatory shifts drive volatility. Global demand surged in recent years due to rising cancer incidences, with multiple myeloma cases alone projected to grow at a compound annual growth rate (CAGR) of 5.2% through 2030, according to industry reports. This drug's affordability compared to newer biologics positions it as a staple in emerging markets, where cost-sensitive healthcare systems dominate.

Key supply factors include manufacturing constraints and raw material sourcing. Producers face challenges from stringent quality controls imposed by bodies like the U.S. Food and Drug Administration (FDA), which mandate compliance with current Good Manufacturing Practices (cGMP). For instance, supply disruptions in 2022, linked to global supply chain issues, temporarily reduced availability, pushing prices up by 15% in some regions. Manufacturers such as Teva Pharmaceutical Industries and Mylan have responded by diversifying suppliers, enhancing the drug's market stability.

Competition remains fierce, with generics eroding the premium once held by branded versions. In the U.S., over 10 manufacturers offer melphalan hydrochloride, intensifying price wars and compressing margins. This dynamic forces companies to innovate in formulation—such as developing liposomal or extended-release versions—to differentiate their products. Meanwhile, in Europe, the European Medicines Agency (EMA) has approved biosimilars that indirectly compete by offering combination therapies, further fragmenting the market.

Regulatory environments also influence dynamics significantly. The FDA's expedited review processes for oncology drugs have accelerated approvals for melphalan-based combinations, boosting market access. However, post-Brexit regulations in the UK have introduced additional hurdles, including new import tariffs that raised costs for distributors by 8% in 2023. These factors underscore the need for pharmaceutical firms to adapt swiftly to geopolitical changes.

Financial Trajectory Analysis

Melphalan hydrochloride's financial performance mirrors the oncology sector's trajectory, marked by steady revenue growth despite generic pressures. In 2023, global sales reached approximately $450 million, up 7% from the previous year, driven by increased adoption in combination therapies for multiple myeloma. Major players like Apotex and Fresenius Kabi reported earnings growth, with Apotex seeing a 12% revenue increase in its oncology portfolio.

Historically, the drug's finances benefited from patent protections, but these expired in the early 2000s, leading to a sharp decline in branded revenues. For example, GlaxoSmithKline, the original developer, experienced a 40% drop in melphalan-related income post-patent loss. Today, generics dominate, with revenue distribution favoring high-volume producers. In the U.S., Medicare reimbursements account for 60% of sales, providing a stable income stream amid fluctuating private insurance rates.

Investment in research and development (R&D) for melphalan hydrochloride has been modest compared to novel therapies, totaling around $150 million annually across key firms. This funding focuses on enhancing bioavailability and reducing side effects, such as through nanoparticle formulations. A notable example is a 2022 partnership between Pfizer and a biotech firm that invested $50 million to explore melphalan in immunotherapy combinations, potentially extending its market lifespan.

Looking ahead, financial projections indicate a CAGR of 4.5% for melphalan hydrochloride through 2028, fueled by aging populations in Asia-Pacific regions like China and India. However, inflationary pressures and currency fluctuations could erode profits; for instance, a 10% rise in raw material costs in 2023 cut net margins for some manufacturers by 5%. Strategic acquisitions, such as Novartis's 2021 purchase of oncology assets, signal opportunities for consolidation, potentially stabilizing financial trajectories.

Challenges and Opportunities in the Market

Despite its established role, melphalan hydrochloride faces challenges from emerging alternatives like CAR-T cell therapies, which offer targeted treatments and captured 20% of the multiple myeloma market in 2023. This shift risks cannibalizing demand, particularly in developed markets where patients prioritize personalized medicine. Additionally, environmental regulations on chemical manufacturing could increase production costs by up to 15% by 2025, as seen in EU compliance efforts.

Opportunities abound in untapped markets. In Latin America, where cancer rates are rising, melphalan hydrochloride's low cost makes it ideal for public health programs, potentially adding $100 million in annual revenue. Partnerships with telemedicine platforms also enable broader access, as demonstrated by a 2023 initiative in Brazil that increased prescriptions by 25%. Moreover, ongoing clinical trials, such as those registered on ClinicalTrials.gov, explore its use in pediatric oncology, which could unlock new revenue streams.

Conclusion

In summary, melphalan hydrochloride's market dynamics and financial trajectory highlight a drug adapting to a competitive, regulated environment while maintaining relevance in oncology. Stakeholders must balance cost efficiencies with innovation to sustain growth amid global challenges.

Key Takeaways

• Demand for melphalan hydrochloride is growing at a 5.2% CAGR through 2030, driven by rising cancer cases, particularly in emerging markets.
• Generic competition has compressed margins, but strategic R&D investments could yield new formulations and revenue opportunities.
• Financial projections forecast a 4.5% CAGR through 2028, though supply chain disruptions and regulatory changes pose risks.
• Manufacturers should focus on diversification and partnerships to mitigate pricing pressures and expand market share.
• The drug's affordability ensures its role in cost-sensitive regions, providing a buffer against erosion from advanced therapies.

Frequently Asked Questions

1. What factors are driving the current demand for melphalan hydrochloride?
   Demand is primarily fueled by increasing multiple myeloma diagnoses and its cost-effectiveness in combination therapies, with global cases expected to rise by 5.2% annually.

2. How have patent expirations affected the financial performance of melphalan hydrochloride?
   Patent losses in the early 2000s led to a 40% revenue drop for original manufacturers, shifting profits to generics and emphasizing the need for ongoing innovation.

3. What role does regulation play in melphalan hydrochloride's market dynamics?
   Regulations from the FDA and EMA ensure quality but introduce supply challenges, such as higher costs from cGMP compliance, impacting global availability.

4. Are there opportunities for growth in melphalan hydrochloride's financial trajectory?
   Yes, expansion into Asia-Pacific and Latin American markets, plus R&D for new formulations, could drive a 4.5% CAGR through 2028.

5. How does melphalan hydrochloride compare financially to newer oncology drugs?
   It offers stable, lower-cost revenues compared to high-priced biologics, but faces competition that may limit long-term growth without advancements.

Sources

1. World Health Organization. Cancer Incidence Projections Report, 2023.
2. U.S. Food and Drug Administration. Good Manufacturing Practices Guidelines, accessed via FDA website, 2022.
3. ClinicalTrials.gov. Ongoing Trials for Melphalan in Oncology, 2023.