ALKERAN Drug Patent Profile

Which patents cover Alkeran, and when can generic versions of Alkeran launch?

Alkeran is a drug marketed by Apotex and is included in two NDAs.

The generic ingredient in ALKERAN is melphalan. There are twelve drug master file entries for this compound. Additional details are available on the melphalan profile page.

Summary for ALKERAN

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	185
Drug Prices:	Drug price information for ALKERAN
What excipients (inactive ingredients) are in ALKERAN?	ALKERAN excipients list
DailyMed Link:	ALKERAN at DailyMed

See drug prices for ALKERAN

Recent Clinical Trials for ALKERAN

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

Sponsor	Phase
St. Louis Children's Hospital Foundation	Phase 1/Phase 2
Washington University School of Medicine	Phase 1/Phase 2
Rising Tide Foundation	Phase 1/Phase 2

See all ALKERAN clinical trials

US Patents and Regulatory Information for ALKERAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	ALKERAN	melphalan hydrochloride	INJECTABLE;INJECTION	020207-001	Nov 18, 1992		DISCN	Yes	No
Apotex	ALKERAN	melphalan	TABLET;ORAL	014691-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for ALKERAN

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

EU/EMA Drug Approvals for ALKERAN

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

International Patents for ALKERAN

See the table below for patents covering ALKERAN around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	108994	Pharmaceutical formulations containing melphalan or melphalan hydrochloride, as well as melphalan and melphalan hydrochloride and processes for preparing them
Hungary	203197	PROCESS FOR PRODUCING INJECTABLE PHARMACEUTICAL COMPOSITIONS COMPRISING MELPHALAN
Hungary	9100335
Hungary	206671	PROCESS FOR PURIFYING MELPHALANE
United Kingdom	8727157
Japan	H01153628	MELPHARANE PREPARATION
Ireland	63996	Pharmaceutical formulations

Supplementary Protection Certificates for ALKERAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	122023000007	Germany		PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
2701720	2290047-6	Sweden		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	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

ALKERAN Market Analysis and Financial Projection

Last updated: February 13, 2026

What is the current market position of ALKERAN?

ALKERAN (melphalan) is an alkylating chemotherapy agent used primarily for multiple myeloma, ovarian cancer, and other hematologic malignancies. It is available in both injectable and oral formulations. The drug has been on the market for several decades, with its first approval in 1964.

Its market share remains significant in niche indications but has diminished in favor of newer therapies, especially targeted agents and immuno-oncology drugs. Despite this, ALKERAN retains relevance in conditioning regimens for stem cell transplants and in regions with limited access to advanced treatments.

How has the market for ALKERAN evolved recently?

The global chemotherapy market is projected to reach USD 50 billion by 2025, with alkylating agents representing roughly 20% of this market. ALKERAN’s contribution has declined over the past five years due to the rise of targeted therapies, such as proteasome inhibitors, IMiDs, and monoclonal antibodies, which offer improved efficacy and fewer side effects.

However, ALKERAN remains in use owing to its low cost, oral administration convenience, and established supply chains. The drug is still listed in national formularies, especially within Asia, Latin America, and Eastern Europe.

What are the key drivers impacting ALKERAN's sales and market growth?

• Therapeutic positioning: Its use in conditioning regimens supports its ongoing demand.
• Pricing and reimbursement policies: Lower price points in emerging markets sustain sales.
• Patent status: ALKERAN has no recent patent protections, leading to generic competition.
• Regulatory environment: Approval requirements vary across regions, influencing availability.
• Clinical guidelines: Inclusion in treatment protocols for specific indications sustains demand.

What are the market challenges facing ALKERAN?

• Emergence of targeted therapies: Drugs such as bortezomib, lenalidomide, and monoclonal antibodies have dominated the multiple myeloma space.
• Safety profile concerns: Alkylating agents are associated with secondary malignancies, myelosuppression, and other toxicities.
• Manufacturing issues: Supply limitations and quality control problems have been reported for older chemotherapies.
• Pricing pressures: Governments and payers push for cost reductions for older chemotherapies.

How do financial dynamics look for ALKERAN?

Revenue and sales forecasts

Estimates suggest global annual sales of ALKERAN hover around USD 50–70 million, mainly driven by markets in India, China, and Eastern Europe. In developed regions like North America and Western Europe, sales are declining, with estimates dropping below USD 20 million annually.

Factors influencing revenue

• Generic competition: Patents have expired; numerous generics compete, driving prices downward.
• Market penetration: Limited growth potential in mature markets.
• Regional variations: Higher usage in lower-income regions where newer agents are less accessible.

Profitability outlook

Manufacturers face margin compression due to price erosion and regulatory pressures. However, low manufacturing costs and continuous demand in specific indications maintain profitability margins.

What are the implications for stakeholders?

• Pharmaceutical companies: Focus may shift toward niche applications of ALKERAN or its combination with newer agents.
• Investors: Revenue prospects are declining, but the drug’s low-cost profile and steady demand in certain markets sustain value.
• Healthcare providers: Shifts toward targeted therapies may phase out ALKERAN in treatment algorithms but could sustain its use in resource-limited settings.

What future developments could impact ALKERAN's market?

• New formulation developments: Extended-release or targeted delivery options.
• Regulatory changes: Stricter safety requirements could limit usage.
• Competitor innovation: Next-generation alkylators or novel conditioning agents.
• Market expansion: Increased use in emerging markets where advanced drugs are less accessible.

---

Key Takeaways

• ALKERAN has a long-standing role in chemotherapy, especially for hematologic and transplant indications.
• Its market share is declining due to competition from targeted therapies but persists via cost advantages.
• Global sales are approximately USD 50–70 million annually, mainly from emerging markets.
• Patent expirations and generics have eroded pricing power.
• Future market prospects depend on regional adoption, regulatory policies, and potential formulation innovations.

---

FAQs

1. What are the primary indications for ALKERAN?
Multiple myeloma, ovarian cancer, leukemia, and as a conditioning agent for stem cell transplantation.

2. How does ALKERAN compare to newer therapies?
It offers lower cost and established familiarity but has a higher toxicity profile and less clinical efficacy in some indications.

3. Are there any ongoing patents or exclusivities?
No; the patent has expired, leading to broad generic competition.

4. Is ALKERAN used outside developed markets?
Yes; it remains a choice in regions with limited access to newer, expensive therapies.

5. What are the main driving factors for ALKERAN's declining sales?
Emerging targeted agents, safety concerns, patent expiry, and market saturation.

---

Cited Sources

[1] Global Oncology Drugs Market Report 2022, Market Research Future.
[2] IMS Health, Oncology Market Data, 2022.
[3] U.S. Food and Drug Administration (FDA) Drug Approvals, 1964–2022.
[4] World Health Organization (WHO), Essential Medicines List.
[5] Company financial reports and industry analyses, 2022–2023.