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, Endo Operations, Fresenius Kabi Usa, Gland Pharma Ltd, Hetero Labs, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, 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:	71
Clinical Trials:	869
Patent Applications:	7,510
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
The Leukemia and Lymphoma Society	Phase 1/Phase 2
St. Louis Children's Hospital Foundation	Phase 1/Phase 2
Rising Tide Foundation	Phase 1/Phase 2

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
Ingenus Pharms Llc	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	210947-001	Feb 18, 2020	AP	RX	No	No
Hikma	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	090303-001	Oct 28, 2010	AP	RX	No	No
Actavis Llc	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	206018-001	Dec 19, 2016	AP	RX	No	No
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes
Hetero Labs	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	215024-001	May 23, 2024	AP	RX	No	No
Apotex	IVRA	melphalan hydrochloride	SOLUTION;INTRAVENOUS	217110-001	Aug 18, 2023		RX	Yes	Yes			Y

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/005173 High-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

MELPHALAN Market Analysis and Financial Projection Experimental

Melphalan Hydrochloride: Market Dynamics and Financial Trajectory

Introduction to Melphalan Hydrochloride

Melphalan Hydrochloride is a chemotherapy drug that has been a cornerstone in the treatment of various malignancies, particularly multiple myeloma and ovarian cancer. As an alkylating agent, it interferes with DNA replication, inhibiting cancer cell growth and making it a vital component in cancer treatment regimens[1].

Market Size and Projection

The global market for Melphalan Hydrochloride has seen significant growth, driven by several key factors:

• Increasing Cancer Incidence: The rising incidence of cancer globally, especially among the geriatric population, has fueled the demand for effective chemotherapy agents like Melphalan Hydrochloride[1][3].
• Generic Versions: The approval of generic versions of Melphalan Hydrochloride has increased competition, driving down prices and making the drug more accessible to a broader patient demographic[1][4].
• Projected Growth: The market is projected to expand steadily over the next decade, with estimates suggesting a substantial increase in market value due to technological advancements and the rising demand for cost-effective treatments[1].

Market Drivers

Several factors are driving the growth of the Melphalan Hydrochloride market:

• Enhanced Formulations: Recent developments in liposomal formulations aim to improve drug delivery directly to cancer cells while minimizing harm to healthy tissue. This has improved patient outcomes and opened new avenues for research and development in oncology[1].
• Strategic Collaborations: Pharmaceutical companies and research institutions are collaborating to develop new therapies that include Melphalan Hydrochloride, exploring synergistic effects with other chemotherapeutic agents[1].
• Cost-Effectiveness: Compared to newer therapies, Melphalan Hydrochloride is relatively affordable, making it a preferred option in developing countries and for patients with limited financial resources[1].

Financial Trajectory

The financial trajectory of Melphalan Hydrochloride is influenced by several key aspects:

• Revenue Growth: Companies like Avenacy have initiated commercial operations for Melphalan Hydrochloride, with U.S. sales reaching approximately $25 million for the twelve months ending in June 2023. This indicates a steady revenue stream from the drug[4].
• Investment Opportunities: The market presents several investment opportunities, including pharmaceutical development, healthcare infrastructure expansion, and research initiatives. Investing in companies that enhance formulations or combinations of Melphalan Hydrochloride can yield significant returns[1].

Impact of Generic Versions

The approval of generic versions of Melphalan Hydrochloride has significantly impacted market dynamics:

• Increased Competition: Generic versions have increased competition, leading to lower prices and making the drug more accessible to healthcare providers and patients[1][4].
• Broader Usage: This change has resulted in broader usage across various healthcare settings, contributing to the drug's market growth[1].

Technological Advancements

Technological advancements are playing a crucial role in the market growth of Melphalan Hydrochloride:

• Liposomal Formulations: The development of liposomal formulations has improved drug delivery and reduced side effects, enhancing patient outcomes and opening new research avenues[1].
• Combination Therapies: Strategic collaborations are focusing on developing new combination therapies that include Melphalan Hydrochloride, further enhancing treatment efficacy[1].

Company-Specific Developments

Companies like Delcath Systems and Avenacy are making significant strides in the market:

• Delcath Systems: Delcath's HEPZATO KIT, which uses Melphalan Hydrochloride for percutaneous hepatic perfusion (PHP), has shown strong demand and rapid uptake by physicians. The company achieved $11.2 million in preliminary Q3 2024 revenue and secured additional financing through warrant exercises to support commercialization and new clinical trials[2].
• Avenacy: Avenacy has launched Melphalan Hydrochloride for Injection in the U.S. market, supported by a global network of development and manufacturing partners. This launch has expanded the availability of the drug and contributed to its revenue growth[4].

Global Oncology Drugs Market Context

The global oncology drugs market, within which Melphalan Hydrochloride operates, is experiencing rapid expansion:

• Market Valuation: The global oncology drugs market was valued at $231.56 billion in 2024 and is projected to reach $532.91 billion by 2031, growing at a CAGR of 12.6%[3].
• Segmentation: The cytotoxic drugs segment, which includes Melphalan Hydrochloride, is expected to hold a significant market share, although targeted therapies are expected to grow rapidly and potentially surpass cytotoxic drugs by 2031[3].

Side Effects and Patient Monitoring

While Melphalan Hydrochloride is effective, it comes with common side effects such as nausea, vomiting, fatigue, and low blood cell counts. Patients are closely monitored during treatment to manage these adverse effects[1].

Future Outlook

The future outlook for Melphalan Hydrochloride is positive, driven by:

• Increasing Cancer Incidence: The rising incidence of cancer globally will continue to drive demand for effective chemotherapy agents.
• Technological Advancements: Continued innovations in drug delivery systems and combination therapies will enhance treatment efficacy and reduce side effects.
• Cost-Effectiveness: The relative affordability of Melphalan Hydrochloride compared to newer therapies will maintain its market presence, especially in developing countries[1].

Key Takeaways

• Melphalan Hydrochloride is a crucial chemotherapy drug used in treating multiple myeloma and ovarian cancer.
• The market for Melphalan Hydrochloride is growing due to increasing cancer incidence, generic versions, and technological advancements.
• Companies like Delcath Systems and Avenacy are contributing to the drug's market growth through innovative formulations and commercial launches.
• The global oncology drugs market is expanding rapidly, with cytotoxic drugs like Melphalan Hydrochloride holding significant market share.

FAQs

1. What is Melphalan Hydrochloride used for? Melphalan Hydrochloride is primarily used to treat multiple myeloma and certain types of ovarian cancer. It may also be used in combination therapies for other malignancies[1].

2. How does Melphalan Hydrochloride work? Melphalan Hydrochloride works by interfering with the DNA of cancer cells, preventing them from dividing and growing. This cytotoxic effect is crucial in shrinking tumors and reducing cancer spread[1].

3. What are the common side effects of Melphalan Hydrochloride? Common side effects include nausea, vomiting, fatigue, and low blood cell counts. Patients are closely monitored during treatment to manage these adverse effects[1].

4. How has the approval of generic versions impacted the market? The approval of generic versions has increased competition, driven down prices, and made the drug more accessible to healthcare providers and patients, leading to broader usage across various healthcare settings[1][4].

5. What are the investment opportunities in the Melphalan Hydrochloride market? Investment opportunities include pharmaceutical development, healthcare infrastructure expansion, and research initiatives that explore the potential of Melphalan Hydrochloride in treating additional cancer types[1].

Sources

1. Market Research Intellect: "Revolutionizing Oncology: The Surge of Melphalan Hydrochloride in Healthcare"[1].
2. Stock Titan: "Delcath Systems Announces Preliminary Third Quarter 2024 Revenue Results"[2].
3. BioSpace: "Oncology Drugs Market to Reach USD 532.91 Billion by 2031"[3].
4. BioSpace: "Avenacy Announces Launch of Melphalan Hydrochloride for Injection in the U.S. Market"[4].
5. NCODA: "Now Approved: PEPAXTO® (melphalan flufenamide)"[5].