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 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-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-eight 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:	128
US Patents:	18
Tradenames:	5
Applicants:	19
NDAs:	22
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	869
Patent Applications:	1,596
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
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 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
Mylan Institutional	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	090270-001	Jun 9, 2009	AP	RX	No	Yes
Meitheal	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	212960-001	May 28, 2021	AP	RX	No	No
Arthur Grp	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	211463-001	Sep 13, 2019	AP	RX	No	No
Ingenus Pharms Llc	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	210947-001	Feb 18, 2020	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

International Patents for melphalan hydrochloride

Country	Patent Number	Title	Estimated Expiration
Israel	216405	תכשיר רוקחי המכיל מלפלן ונגזרת ציקלודקסטרין ושימוש בו להכנת תרופות (Pharmaceutical composition comprising melphalan and a cyclodextrin derivative and its use in the manufacture of medicaments)
Mexico	2010004900	COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)
Russian Federation	2615385	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME RELATED APPLICATIONS)
Japan	2016166368	アルキル化シクロデキストリン組成物ならびにその調製方法および使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITION AS WELL AS PREPARATION METHOD AND USE METHOD THEREOF)

Supplementary Protection Certificates for melphalan hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	CR 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 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	CA 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	122023000007	Germany		PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817

Melphalan hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Melphalan Hydrochloride

Introduction to Melphalan Hydrochloride

Melphalan hydrochloride is a chemotherapy drug used primarily in the treatment of multiple myeloma and certain types of cancer. Its efficacy and the growing demand for cancer treatments have positioned it as a significant player in the oncology market.

Market Size and Growth Projections

The global melphalan hydrochloride API market is anticipated to experience substantial growth. As of 2024, the market size was valued at approximately USD 322.02 million and is projected to reach USD 456.7 million by 2031, exhibiting a compound annual growth rate (CAGR) of 6.00% during this period[1].

Driving Factors

Several factors are driving the growth of the melphalan hydrochloride market:

Increasing Cancer Incidence

The rising incidence of cancer, particularly multiple myeloma, is a major driver. As the global population ages and lifestyle factors contribute to higher cancer rates, the demand for effective treatments like melphalan hydrochloride is increasing[1].

Technological Advancements

Advancements in pharmaceutical technology and manufacturing processes have improved the quality and availability of melphalan hydrochloride. This has enhanced its market appeal and expanded its use in various medical settings[1].

Market Segmentation

The melphalan hydrochloride market is segmented based on several criteria:

Type

The market is classified into two main types based on purity: Purity ≥ 98% and Purity < 98%. The higher purity segment is generally preferred for its consistency and efficacy in medical applications[1].

Application

Melphalan hydrochloride is primarily used in the form of injections. Other applications, though less common, also contribute to the market's overall growth. The injection segment dominates due to its direct and effective delivery method[1].

Regional Analysis

The global melphalan hydrochloride market is segmented into five major regions: North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region has its own set of market dynamics, driven by local healthcare policies, economic conditions, and the prevalence of cancer.

• North America and Europe: These regions are expected to remain significant due to advanced healthcare systems and high awareness of cancer treatments.
• Asia-Pacific: This region is anticipated to show rapid growth due to increasing healthcare expenditure and a large patient population[3].

Competitive Landscape

The melphalan hydrochloride market is competitive, with several key players:

• Fresenius Kabi
• Spectrum Pharmaceuticals
• Meitheal Pharmaceutical
• Dr. Reddy's
• Sagent
• Athenex
• Mediclone Biotech
• Mylan
• GSK
• Par Pharmaceuticals

These companies are focusing on improving product quality, expanding distribution networks, and investing in research and development to stay competitive[3].

Clinical Efficacy and Pharmacokinetics

Melphalan hydrochloride has shown significant clinical efficacy, particularly in myeloablative conditioning for multiple myeloma patients undergoing autologous transplantation. Studies have demonstrated high response rates and effective myeloablation and engraftment times[4].

• Response Rates: Clinical trials have shown a 95% response rate post-treatment compared to 79% pre-treatment.
• Myeloablation and Engraftment: The drug achieves myeloablation in a mean time of 2.9 days and engraftment in a mean time of 11 days[4].

Pharmacokinetics

The pharmacokinetics of melphalan hydrochloride involve rapid distribution and elimination. Key parameters include:

• Half-lives: Distribution-phase half-life of 10 minutes and terminal-elimination-phase half-life of 75 minutes.
• Clearance: Average total body clearance of 7 to 9 mL/min/kg.
• Volume of Distribution: Ranges from 35.5 to 185.7 L/m²[4].

Financial Trajectory

The financial trajectory of the melphalan hydrochloride market is promising, driven by increasing demand and expanding applications.

• Revenue Growth: The market is expected to grow from USD 322.02 million in 2024 to USD 456.7 million by 2031, with a CAGR of 6.00%[1].
• Investment Opportunities: The growing demand for cancer treatments and the advancements in pharmaceutical technology present significant investment opportunities in this market.

Challenges and Opportunities

While the market for melphalan hydrochloride is growing, there are challenges and opportunities to consider:

Challenges

• Regulatory Hurdles: Strict regulatory requirements can delay market entry and affect profitability.
• Competition: The presence of multiple competitors can lead to pricing pressures and market share competition.

Opportunities

• Emerging Markets: Expanding into emerging markets in Asia-Pacific and Latin America can provide significant growth opportunities.
• Research and Development: Investing in R&D can lead to improved formulations and new applications, further expanding the market[3].

Key Takeaways

• The melphalan hydrochloride market is projected to grow significantly, driven by increasing cancer incidence and technological advancements.
• The market is segmented by type and application, with the injection segment being the most dominant.
• Key players are focusing on improving product quality and expanding distribution networks.
• Clinical efficacy and favorable pharmacokinetics support the drug's use in multiple myeloma treatment.
• The financial trajectory is positive, with a projected CAGR of 6.00% from 2024 to 2031.

Frequently Asked Questions (FAQs)

1. What is the projected market size of the melphalan hydrochloride API market by 2031? The melphalan hydrochloride API market is expected to reach USD 456.7 million by 2031[1].

2. What is the CAGR of the melphalan hydrochloride API market from 2024 to 2031? The market is expected to exhibit a CAGR of 6.00% from 2024 to 2031[1].

3. What are the primary applications of melphalan hydrochloride? Melphalan hydrochloride is primarily used in the form of injections, with other applications being less common[1].

4. Which regions are expected to drive the growth of the melphalan hydrochloride market? North America, Europe, and the Asia-Pacific region are expected to be significant drivers of market growth[3].

5. What are the key factors driving the growth of the melphalan hydrochloride market? The increasing incidence of cancer and technological advancements in pharmaceutical manufacturing are key drivers of market growth[1].

Cited Sources:

1. Proficient Market Insights - Melphalan Hydrochloride API Market Size, Share & Growth
2. Dataintelo - Melphalan Injection Market Research Report 2032
3. Cognitive Market Research - Melphalan Injection Market Report 2024 (Global Edition)
4. FDA - CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW of Melphalan HCl for Injection
5. Market Research Intellect - Melphalan Hydrochloride Market Size And Projection