MELPHALAN HYDROCHLORIDE - Generic Drug Details

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

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:	907
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
Incyte Corporation	PHASE2
Fred Hutchinson Cancer Center	PHASE2
Vastra Gotaland Region	PHASE1

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
Sagent Pharms Inc	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	201379-001	Feb 28, 2017	AP	RX	No	No
Apotex	IVRA	melphalan hydrochloride	SOLUTION;INTRAVENOUS	217110-001	Aug 18, 2023		RX	Yes	Yes	10,537,520		Y
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	11,020,363		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
Mexico	352459	COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)
Japan	4923144
Spain	2728280
Israel	243654	תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions)

Supplementary Protection Certificates for MELPHALAN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	202240050	Slovenia		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; NATIONAL AUTHORISATION NUMBER: EU/1/22/1669/001; DATE OF NATIONAL AUTHORISATION: 20220817; AUTHORITY FOR NATIONAL AUTHORISATION: EU
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	2290047-6	Sweden		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818

Market Dynamics and Financial Trajectory for Melphalan Hydrochloride

Last updated: February 10, 2026

Melphalan hydrochloride is an alkylating agent used primarily for multiple myeloma and ovarian cancer treatment. Its market profile is shaped by patent status, regulatory pathways, competitive landscape, and clinical demand.

Market Overview

As of 2023, Melphalan hydrochloride remains an essential chemotherapeutic agent, particularly in multiple myeloma management. It is marketed both as a standalone drug and in combination regimens, such as VISTA (bortezomib, melphalan, prednisolone).

Patent and Regulatory Status

• The original patent for Melphalan hydrochloride expired in the early 2000s, leading to the proliferation of generic versions.
• Several generic manufacturers possess approval from regulatory agencies (FDA, EMA), increasing price competition.
• No recent novel formulations or combinations significantly extend patent exclusivity.

Market Size and Revenue Projections

• The global oncology drug market was valued at approximately $222 billion in 2022, with chemotherapies like Melphalan representing a small but steady segment.
• Melphalan’s revenue in 2022 primarily derived from generic sales, estimated between $200 million to $400 million globally.
• Demand remains stable due to its status as a standard-of-care, with no significant off-label or alternative therapies replacing it.

Key Market Drivers

• Clinical Demand: Established efficacy in multiple myeloma and ovarian cancer ensures consistent prescriptions.
• Generic Competition: Multiple manufacturers low operating costs enable aggressive pricing strategies, restraining revenue growth.
• Adoption of Newer Agents: Introduction of targeted therapies (e.g., immunomodulators, proteasome inhibitors) affects the growth rate but does not diminish Melphalan's role in specific treatment lines.

Market Challenges

• Side Effect Profile: Toxicity, including marrow suppression and gastrointestinal effects, limits broader application.
• Emerging Therapies: Novel agents such as monoclonal antibodies and CAR-T cell therapy reduce dependency on traditional chemotherapies.
• Regulatory Pressures: Increased focus on personalized medicine and smaller, targeted treatment regimens influence future usage.

Financial Projections

Year	Estimated Revenue (USD million)	Key Factors
2023	200 – 400	Steady demand, generic competition
2025	180 – 350	Slight decline due to competition from newer agents
2030	150 – 300	Continued decline, but stable in existing indications

Potential Market Impact of Innovation

• No current pipeline indicates significant innovation or reformulation in development.
• Biotech firms have explored liposomal formulations and targeted delivery systems but lack commercial-scale approval.

Conclusion

Melphalan hydrochloride’s market remains steady under its established role in oncology treatment, especially as a backbone therapy in multiple myeloma. Revenue streams face pressure from generics and emerging therapies, projecting a gradual decline over the next decade unless new formulations or indications emerge.

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Key Takeaways

• The patent expiry contributed to the proliferation of generics, capping potential revenue growth.
• Demand persists in specific cancer treatments, but new therapies reduce its broader application.
• Market size is stable but faces downward pressure due to competition and advancing treatments.
• Future growth depends on pipeline innovations or combination therapies enhancing efficacy or reducing toxicity.

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FAQs

1. Does Melphalan hydrochloride have any ongoing patent protection?
No, its original patent expired in the early 2000s, leading to multiple generic formulations.

2. What are the main competitors to Melphalan hydrochloride?
Other alkylating agents and newer targeted therapies, such as bortezomib and lenalidomide, have replaced Melphalan in some indications.

3. Are there any novel formulations of Melphalan under development?
Limited development exists; some research focuses on liposomal formulations or targeted delivery, but none have received regulatory approval.

4. How does the side effect profile affect its market?
Toxicity limits broader use; side effects like marrow suppression restrict off-label or extended applications.

5. What is the outlook for Melphalan in the next decade?
Market demand will likely decline gradually, stabilized only by its entrenched role in combination regimens for multiple myeloma.

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Citations

[1] IQVIA, "Global Oncology Market Report," 2022.
[2] FDA, "Drug Approvals & Regulatory Information," 2022.
[3] EvaluatePharma, "Revenue and Market Data," 2023.