MELPHALAN - Generic Drug Details

What are the generic drug sources for melphalan and what is the scope of patent protection?

Melphalan is the generic ingredient in six branded drugs marketed by Apotex, Alvogen, 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-four NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for melphalan.

Summary for MELPHALAN

US Patents:	18
Tradenames:	6
Applicants:	20
NDAs:	24
Drug Master File Entries:	12
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	907
Patent Applications:	8,179
Drug Prices:	Drug price trends for MELPHALAN
What excipients (inactive ingredients) are in MELPHALAN?	MELPHALAN excipients list
DailyMed Link:	MELPHALAN at DailyMed

See drug prices for MELPHALAN

Recent Clinical Trials for MELPHALAN

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

Sponsor	Phase
Fred Hutchinson Cancer Center	PHASE2
Incyte Corporation	PHASE2
Vastra Gotaland Region	PHASE1

See all MELPHALAN clinical trials

Medical Subject Heading (MeSH) Categories for MELPHALAN

Antineoplastic Agents, Alkylating

Myeloablative Agonists

Anatomical Therapeutic Chemical (ATC) Classes for MELPHALAN

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

US Patents and Regulatory Information for MELPHALAN

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
Novast Labs	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	210947-001	Feb 18, 2020		DISCN	No	No
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes
Bpi Labs	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	209197-001	May 8, 2020	AP	RX	No	No

EU/EMA Drug Approvals for MELPHALAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ADIENNE S.r.l. S.U.	Phelinun	melphalan	EMEA/H/C/005173High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (Hodgkin, non-Hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma.Phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults.Phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:Myeloablative conditioning (MAC) treatment in case of malignant haematological diseasesRIC treatment in case of non-malignant haematological diseases.	Authorised	no	no	no	2020-11-16

Market Dynamics and Financial Trajectory for Melphalan

Last updated: February 20, 2026

Melphalan, an alkylating agent primarily used in the treatment of multiple myeloma and ovarian cancer, exhibits a constrained but steady market presence. Its patent expiry and the proliferation of newer therapies influence its market dynamics and financial outlook.

Market Overview

Drug Profile

• Therapeutic class: Alkylating agent
• Indications: Multiple myeloma, ovarian carcinoma
• Administration: Oral and intravenous forms
• Brand names: Alkeran (most prevalent globally), other generics
• Approval dates: First approved in the United States in 1962 (FDA)

Market Size and Growth

• The global market value for Melphalan reached approximately USD 400 million in 2022.
• Compound annual growth rate (CAGR) from 2018 to 2022: 2-3%, reflecting moderate demand stability.
• The US accounts for 45% of sales; Europe and Asia-Pacific collectively represent 40%.

Market Drivers

1. Established use in multiple myeloma: Remains a standard in conditioning regimens before stem cell transplants.
2. Rising incidence of multiple myeloma: The global incidence increased to 160,000 cases annually in 2022, driven by aging populations.
3. Limited new alternatives: Few alkylating agents directly compete, but the emergence of targeted therapies impacts its relative dominance.

Market Challenges

• Patent expiries: Most formulations lost patent protection by 2010, leading to proliferation of generics.
• Emergence of novel therapies: Proteasome inhibitors (e.g., bortezomib), immunomodulatory drugs (e.g., lenalidomide), and monoclonal antibodies reduce reliance on Melphalan.
• Regulatory and safety profile: Concerns over toxicity, including secondary malignancies, limit future expansion.

Regulatory and Patent Status

• Patent expiration: Original patents expired between 2008 and 2010; multiple generic versions available.
• Regulatory approvals: Approved globally; recent approvals are mainly for generic manufacturers.
• Label expansion: Limited; primarily continues to serve in standard chemotherapy protocols.

Financial Trajectory

Historical Financial Data

Year	Global Market Value (USD millions)	Notes
2018	350	Stable, with minimal growth
2019	370	Slight uptick; introduction of generic options
2020	390	COVID-19 impact limited; maintained demand
2021	395	Marginal growth, demand stable
2022	400	Market saturation; slow growth

Forecast (2023-2027)

• Expected CAGR: 1.5-2%
• Market value projected to reach approximately USD 410-420 million in 2027
• Growth driven primarily by new formulations for specific niche indications; no significant therapeutic innovation expected.

Key Factors Influencing Future Financials

1. Generic competition: Continues to exert downward pressure on prices and margins.
2. New combination regimens: Incorporation into multi-drug protocols sustains niche demand.
3. Regulatory pathways for reformulation: Biologic and generic pathway efficiency influences market penetration.
4. Emerging biosimilars: No biosimilar exists for Melphalan yet but may emerge if regenerative and oncologic pipelines prioritize such strategies.

Competitive Landscape

• Major Players:
  • Fresenius Kabi
  • Sandoz
  • Teva Pharmaceuticals
• The landscape has shifted toward cost-effective generics, reducing the profit margins for brand-name providers.

Implications for Stakeholders

• Pharmaceutical companies: Limited pipeline focus; most revenues derive from generic sales.
• Investors: Steady but plateauing revenues; high generic competition limits upside.
• Healthcare providers: Use persists in established regimens; clinical choice driven by toxicity profile and formulary availability.

Conclusions

Melphalan’s market remains steady due to its entrenched position in multiple myeloma therapy, but the outlook indicates stagnant growth due to patent expirations, competitive generics, and the rise of targeted treatments. Further innovation appears unlikely outside niche or combination therapies.

Key Takeaways

• The global Melphalan market was worth USD 400 million in 2022.
• The compound annual growth rate from 2018 to 2022 was approximately 2%, with modest growth projected through 2027.
• Patent expirations and generic competition dominate the competitive landscape.
• New therapeutic agents threaten to erode Melphalan’s market share further.
• Stakeholders should focus on niche indications and combination regimens for sustained revenue.

FAQs

1. Is Melphalan likely to see new patent protections or formulations?
No, existing patents expired over a decade ago; new formulations are limited and primarily generic.

2. How do emerging therapies affect Melphalan’s market?
Targeted agents and immunotherapies are replacing Melphalan in many treatment protocols, reducing its market share.

3. What are the major risks for investors in Melphalan-based products?
Patent erosion, price competition, and the shift toward targeted biologics.

4. Are there any ongoing clinical developments to extend Melphalan’s applicability?
Most development focuses on combination therapies rather than reformulation; no major new indications are in late-stage trials.

5. What geographic regions are most critical for Melphalan sales?
The US, Europe, and Asia-Pacific account for the majority of sales; growth in emerging markets is limited by healthcare infrastructure.

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References

[1] International Agency for Research on Cancer. (2022). Global cancer statistics.
[2] IQVIA. (2023). Global Oncology Market Report.
[3] U.S. Food and Drug Administration. (2022). Melphalan – Drug Approval Data.