Mechlorethamine hydrochloride - Generic Drug Details

What are the generic sources for mechlorethamine hydrochloride and what is the scope of freedom to operate?

Mechlorethamine hydrochloride is the generic ingredient in two branded drugs marketed by Helsinn and Recordati Rare, and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mechlorethamine hydrochloride has fifty patent family members in twenty countries.

There is one drug master file entry for mechlorethamine hydrochloride. One supplier is listed for this compound.

Summary for mechlorethamine hydrochloride

International Patents:	50
US Patents:	6
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	21
What excipients (inactive ingredients) are in mechlorethamine hydrochloride?	mechlorethamine hydrochloride excipients list
DailyMed Link:	mechlorethamine hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for mechlorethamine hydrochloride

Constraining patent/regulatory exclusivity:

7,838,564

Dosage:

GEL;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for mechlorethamine hydrochloride

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

Sponsor	Phase
Soligenix	Phase 2
Seattle Genetics, Inc.	Phase 2
Seagen Inc.	Phase 2

See all mechlorethamine hydrochloride clinical trials

Pharmacology for mechlorethamine hydrochloride

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for mechlorethamine hydrochloride

Alkylating Agents

Antineoplastic Agents, Alkylating

Chemical Warfare Agents

Irritants

US Patents and Regulatory Information for mechlorethamine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes	7,872,050
Recordati Rare	MUSTARGEN	mechlorethamine hydrochloride	INJECTABLE;INJECTION	006695-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes	8,450,375		Y
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes	7,838,564		Y

International Patents for mechlorethamine hydrochloride

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009120493
World Intellectual Property Organization (WIPO)	2006099385
Slovenia	2273876
Denmark	2273876

Supplementary Protection Certificates for mechlorethamine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1858864	17C1029	France		PRODUCT NAME: CHLORMETHINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER LE CHLORHYDRATE.; REGISTRATION NO/DATE: EU/1/16/1171 20170307
1858864	PA2017026,C1858864	Lithuania		PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864	PA2017026	Lithuania		PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864	C20170027 00259	Estonia		PRODUCT NAME: KLOORMETIIN;REG NO/DATE: EU/1/16/1171 07.03.2017

Market Dynamics and Financial Trajectory for Mechlorethamine Hydrochloride

Last updated: July 27, 2025

Introduction

Mechlorethamine hydrochloride, historically known as nitrogen mustard, is a chemotherapeutic agent primarily used for treating Hodgkin’s lymphoma and certain other hematologic malignancies. Its unique position as one of the earliest alkylating agents in cancer therapy has both shaped its market presence and dictated its evolving financial trajectory. Despite its age and the advent of newer therapies, stratified factors such as regulatory pathways, manufacturing complexities, and clinical demand continue to influence its market dynamics and revenue potential.

Pharmacological Profile and Clinical Indications

Mechlorethamine hydrochloride functions by forming cross-links in DNA, preventing cell division and inducing apoptosis. Its robust efficacy in hematological cancers renders it a cornerstone in specific chemotherapeutic protocols. However, the drug’s toxicity profile, including severe myelosuppression and tissue necrosis if administered improperly, necessitates specialized handling and limits broader application.

Currently, it remains approved mainly for Hodgkin’s lymphoma, with off-label use in certain other cancers and experimental settings. The narrow scope of approved indications constrains its market expansion potential, but specialized niche positioning sustains its demand within oncology centers with established chemotherapy regimens.

Market Dynamics

Regulatory and Patent Landscape

Mechlorethamine hydrochloride is a generic, with patent protections long expired. Its regulatory pathway is well-established, with approvals dating back to the mid-20th century under various national agencies including the FDA and EMA. The absence of patent exclusivity means less room for premium pricing, forcing market participants to compete mainly on manufacturing quality, cost, and supply reliability.

Manufacturing Challenges and Supply Chain

Manufacturing of mechlorethamine hydrochloride involves handling hazardous intermediates, requiring stringent safety and environmental controls. As a result, the production process is complex and costly relative to more modern chemotherapeutics. Supply chain disruptions have historically impacted availability, affecting market stability.

Market Competition

Though used for specific indications, existing competitors include newer alkylating agents and targeted therapies with improved safety profiles. Monoclonal antibodies and immunotherapy agents have edged out traditional chemotherapeutics in many indications, often offering superior efficacy and tolerability. Nevertheless, for selected chemotherapy regimens, mechlorethamine remains a fallback or adjunct, particularly in regions with limited access to novel treatments.

Clinical and Technological Trends

Emerging interest in targeted delivery systems, such as liposomal formulations or conjugates, aims to mitigate toxicity and enhance efficacy. These innovations may extend the clinical utility of mechlorethamine but are currently at experimental or early-development stages. The adoption of personalized medicine and biomarker-driven protocols could modify its usage pattern, either reducing or, in some cases, expanding its niche application.

Market Size and Revenue Projections

The global market for traditional chemotherapies is projected to decline gradually as targeted and immunotherapies dominate oncology treatment landscapes. Nonetheless, in regions like Latin America, Africa, and parts of Asia, legacy drugs like mechlorethamine still hold significance due to affordability and existing infrastructure.

Current revenue estimates indicate a stable but modest market, with annual sales in the range of $20-50 million globally. The patent expiration, combined with safety concerns and competition, suggests a downward trend in revenue over the next five years. However, niche clinical applications and potential reformulations could offer localized or segment-specific revenue pockets.

Financial Trajectory Analysis

Historical Revenue Trends

Historically, revenue peaked during the late 20th century when chemotherapy protocols heavily depended on agents like mechlorethamine. The advent of targeted therapies, including brentuximab vedotin and immune checkpoint inhibitors, have led to a decline in reliance on traditional alkylating agents.

Future Revenue Outlook

Forecasts suggest a continued decline in overall market share, driven by the following factors:

• Replacement by newer, safer therapies with better efficacy.
• Regulatory pressures to improve safety and handling.
• Reduced formulary inclusion in developed markets.

However, in emerging markets and specific niche uses, demand may remain relatively stable. The development of improved formulations or combination regimens could temporarily stabilize or enhance sales.

Investment and Revenue Drivers

Key drivers influencing future financial performance include:

• Regulatory approvals for novel formulations that improve safety and administration ease.
• Strategic alliances and licensing agreements facilitating broader distribution in developing economies.
• Clinical research demonstrating expanded indications or combination regimens—potentially reviving interest in the drug's utility.
• Market entry of biosimilars and generics, further lowering costs.

Risks and Challenges

Owning a diminishing market share exposes operators to risks such as:

• Regulatory restrictions due to safety concerns.
• Market obsolescence with the introduction of advanced therapeutics.
• Supply chain vulnerabilities impacting consistent availability.

Strategic Outlook

For pharmaceutical entities invested in or considering the mechlorethamine hydrochloride market, focusing on niche applications, optimizing manufacturing efficiency, and pioneering reformulations offer pathways for sustainable revenue. Collaborations with research institutions to explore new delivery platforms could also position the drug favorably amid evolving treatment protocols.

Key Takeaways

• Limited Market Growth: Mechlorethamine hydrochloride's market is declining, primarily due to competition from newer therapies with better safety profiles.
• Niche Utility: Its continued relevance hinges on niche clinical use, especially in regions with limited access to advanced treatments.
• Manufacturing Complexity: Handling hazardous materials increases costs and supply risks, impacting profitability.
• Potential for Reformulation: Innovations like targeted delivery systems could extend its clinical utility and stabilize revenues.
• Emerging Markets' Significance: Developing economies may sustain demand longer than developed markets, emphasizing the need for strategic localization.

FAQs

Q1: What are the primary therapeutic indications for mechlorethamine hydrochloride?
A1: It is mainly indicated for Hodgkin’s lymphoma and certain other hematologic malignancies, often used within combination chemotherapy protocols.

Q2: How does patent status affect the market for mechlorethamine hydrochloride?
A2: Being a generic drug with expired patents, it faces intense price competition, limiting profit margins and incentives for innovation.

Q3: What are the main challenges in manufacturing mechlorethamine hydrochloride?
A3: Its synthesis involves hazardous intermediates requiring specialized safety measures, increasing production costs and supply chain risks.

Q4: Can reformulations or new delivery systems extend the drug’s market life?
A4: Yes, innovations like liposomal formulations may improve safety and efficacy, potentially revitalizing clinical utility and revenue.

Q5: What is the outlook for mechlorethamine hydrochloride in emerging markets?
A5: Demand remains comparatively higher due to cost considerations and limited access to newer therapies, providing ongoing niche opportunities.

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Sources:

1. Global Oncology Drugs Market Analysis, 2022.
2. FDA Drug Approvals and Historical Data.
3. ClinicalUse and Safety Profiles of Alkylating Agents.
4. Industry Reports on Generic Oncology Drugs, 2023.
5. Emerging Technologies in Chemotherapy Delivery Systems.