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
Patent Applications:	6,941
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

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			Y
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			Y
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes			Y

International Patents for mechlorethamine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Spain	2727523
China	101175735	Stabilized compositions of volatile alkylating agents and methods of using thereof
Lithuania	3494960
Cyprus	1123974
China	102036557	Stabilized compositions of alkylating agents and methods of using same

Supplementary Protection Certificates for mechlorethamine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1858864	36/2017	Austria		PRODUCT NAME: CHLORMETHIN; REGISTRATION NO/DATE: EU/1/16/1171 (MITTEILUNG) 20170307
1858864	C20170027 00259	Estonia		PRODUCT NAME: KLOORMETIIN;REG NO/DATE: EU/1/16/1171 07.03.2017
1858864	2017C/033	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1858864	LUC00033	Luxembourg		PRODUCT NAME: CHLORMETHINE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (LEDAGA); AUTHORISATION NUMBER AND DATE: EU/1/1671171 20170307
1858864	17C1029	France		PRODUCT NAME: CHLORMETHINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER LE CHLORHYDRATE.; REGISTRATION NO/DATE: EU/1/16/1171 20170307

Mechlorethamine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mechlorethamine Hydrochloride

Introduction

Mechlorethamine hydrochloride, commonly known as nitrogen mustard, is an alkylating agent used in the treatment of various types of cancer, including cutaneous T-cell lymphoma (CTCL). Here, we delve into the market dynamics and financial trajectory of this drug, particularly focusing on its use in CTCL treatment.

Market Size and Growth

The cutaneous T-cell lymphoma market, where mechlorethamine hydrochloride plays a significant role, is anticipated to grow over the coming years. As of 2021, the CTCL market size in the seven major markets (US, EU5, and Japan) was estimated to be around USD 399 million. This market is expected to increase, with a projected Compound Annual Growth Rate (CAGR) of 3.7% from 2022 to 2032, primarily driven by the lack of curative treatments and the ongoing development of novel therapies[1].

FDA Approvals and Regulatory Landscape

Mechlorethamine hydrochloride, under the brand name Valchlor, received FDA approval in August 2013 for the topical treatment of stage IA and IB mycosis fungoides-type CTCL in patients who have received prior skin-directed therapy. This approval marked a significant milestone in the treatment of CTCL, as it provided a targeted therapy for early-stage patients[1][2][4].

Clinical Use and Indications

Mechlorethamine hydrochloride is specifically indicated for the treatment of mycosis fungoides, the most common type of CTCL. It is used in patients with stage I disease who have had prior skin-directed therapy. The drug works by inhibiting rapidly proliferating cells, making it effective against the skin lesions characteristic of CTCL[1][2][4].

Competitive Landscape

The CTCL treatment market is characterized by several pharmaceutical companies working on novel therapies. Companies such as Soligenix, Philogen, Merck Sharp & Dohme Corp, and others are actively involved in developing new treatments. This competitive landscape drives innovation and potentially increases the market size as new therapies are introduced[1].

Financial Considerations

The financial trajectory of mechlorethamine hydrochloride is influenced by several factors, including its efficacy, cost, and market demand. Given its approval for a specific indication in CTCL, the drug has a niche market but one that is growing due to the lack of alternative treatments. The cost of Valchlor, which contains 0.016% mechlorethamine, is a significant factor in its financial performance. The drug's pricing strategy must balance profitability with patient accessibility, especially since CTCL is classified as a rare disease[1][4].

Challenges and Opportunities

One of the key challenges in the development and marketing of mechlorethamine hydrochloride is the rare nature of CTCL, which makes clinical trials and market assessments more complex. However, this rarity also presents opportunities for pharmaceutical companies to develop and market therapies that can significantly impact the lives of patients. The lack of curative treatments for CTCL means there is a strong demand for effective therapies, which can drive market growth and financial returns for companies investing in this area[1][3].

Regulatory and Reimbursement Hurdles

The regulatory and reimbursement landscape can significantly impact the financial trajectory of mechlorethamine hydrochloride. For instance, the European Commission's approval of Ledaga (chlormethine gel), the European counterpart of Valchlor, highlights the importance of regulatory alignment. Additionally, reimbursement issues, such as those faced by repurposed orphan drugs, can affect the drug's accessibility and profitability. Ensuring regulatory and reimbursement support is crucial for the long-term financial success of the drug[1][3].

Future Outlook

The future outlook for mechlorethamine hydrochloride in the CTCL market is promising. With ongoing research and development in the field, there is potential for expanded indications and improved treatment outcomes. The anticipated launch of new therapies will further boost the market, although it is essential for these therapies to stand out in terms of cost, efficacy, and other relevant parameters to impact the market positively[1].

Key Takeaways

• Market Growth: The CTCL market is expected to grow, driven by the lack of curative treatments and ongoing development of novel therapies.
• FDA Approvals: Mechlorethamine hydrochloride (Valchlor) received FDA approval in 2013 for the treatment of stage IA and IB mycosis fungoides-type CTCL.
• Clinical Use: The drug is indicated for the treatment of mycosis fungoides and works by inhibiting rapidly proliferating cells.
• Competitive Landscape: Several pharmaceutical companies are actively involved in developing new CTCL treatments.
• Financial Considerations: The drug's financial performance is influenced by its efficacy, cost, and market demand.
• Challenges and Opportunities: The rare nature of CTCL presents both challenges and opportunities for pharmaceutical companies.
• Regulatory and Reimbursement: Ensuring regulatory and reimbursement support is crucial for the drug's long-term financial success.

FAQs

Q: What is mechlorethamine hydrochloride used for? A: Mechlorethamine hydrochloride is used for the treatment of cutaneous T-cell lymphoma (CTCL), specifically mycosis fungoides, in patients who have received prior skin-directed therapy.

Q: When was Valchlor approved by the FDA? A: Valchlor (mechlorethamine hydrochloride) was approved by the FDA in August 2013 for the topical treatment of stage IA and IB mycosis fungoides-type CTCL.

Q: What are the key challenges in the development of CTCL treatments? A: The key challenges include the rare nature of CTCL, which complicates clinical trials and market assessments, and regulatory and reimbursement hurdles.

Q: How is the CTCL market expected to grow? A: The CTCL market is expected to grow at a CAGR of 3.7% from 2022 to 2032, driven by the lack of curative treatments and ongoing development of novel therapies.

Q: Which companies are involved in developing CTCL treatments? A: Several pharmaceutical companies, including Soligenix, Philogen, Merck Sharp & Dohme Corp, and others, are actively involved in developing new CTCL treatments.

Sources

1. DelveInsight: Insights Into The Cutaneous T-cell Lymphoma Treatment Market.
2. NCI: Mechlorethamine Hydrochloride - NCI.
3. Frontiers in Pharmacology: Drug Repurposing for Rare Diseases: A Role for Academia.
4. DrugBank: Mechlorethamine: Uses, Interactions, Mechanism of Action - DrugBank.