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VALCHLOR Drug Patent Profile

Which patents cover Valchlor, and what generic alternatives are available?

Valchlor is a drug marketed by Helsinn and is included in one NDA. There are six patents protecting this drug.

This drug has fifty patent family members in twenty countries.

The generic ingredient in VALCHLOR is mechlorethamine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the mechlorethamine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Valchlor

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 7, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VALCHLOR

International Patents:	50
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	8
Patent Applications:	4,819
Drug Prices:	Drug price information for VALCHLOR
What excipients (inactive ingredients) are in VALCHLOR?	VALCHLOR excipients list
DailyMed Link:	VALCHLOR at DailyMed

See drug prices for VALCHLOR

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

Constraining patent/regulatory exclusivity:

7,838,564

NDA:

202317

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 VALCHLOR

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

Sponsor	Phase
Soligenix	Phase 2
Centre for Human Drug Research, Netherlands	N/A
Recordati Rare Diseases	N/A

See all VALCHLOR clinical trials

Pharmacology for VALCHLOR

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

US Patents and Regulatory Information for VALCHLOR

VALCHLOR is protected by six US patents.

This potential generic entry date is based on patent 7,838,564.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes	8,501,818		Y
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes	8,501,819
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	9,382,191		Y
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes	7,838,564		Y

International Patents for VALCHLOR

When does loss-of-exclusivity occur for VALCHLOR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Lithuania

Luxembourg

New Zealand

Poland

Portugal

Slovenia

South Korea

Spain

Turkey

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VALCHLOR around the world.

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
World Intellectual Property Organization (WIPO)	2009120493

Supplementary Protection Certificates for VALCHLOR

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
1858864	CR 2017 00033	Denmark		PRODUCT NAME: CHLORMETHINE, HERUNDER CHLORMETHINE HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1171 20170307

VALCHLOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Valchlor

Introduction to Valchlor

Valchlor, also known as Ledaga in the EU, is the first and only FDA-approved topical formulation of mechlorethamine, an alkylating agent used for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL), a rare type of skin cancer[1].

Approval and Launch

Valchlor was launched in the U.S. at the end of 2013 and received approval from the European Commission in March 2017. It has been granted orphan drug designation in both the U.S. and the EU, reflecting its importance in treating a rare and debilitating condition[1].

Market Size and Growth

The cutaneous T-cell lymphoma (CTCL) market, which includes Valchlor, is anticipated to grow. As of 2021, the CTCL market size in the seven major markets (U.S., EU5, and Japan) was estimated to be USD 399 million, with an expected growth rate of 3.7% CAGR from 2022 to 2032[4].

Sales Performance

Valchlor has shown significant sales growth since its launch. In 2014, its sales were $11 million, which increased to $35 million globally by 2017. This growth indicates a strong market demand for the drug, particularly in the U.S. where it is widely reimbursed by public and commercial payers[1].

Acquisition by Helsinn Group

In March 2018, Helsinn Group acquired the worldwide rights to Valchlor/Ledaga from Actelion Pharmaceuticals Ltd. This acquisition was part of Helsinn's strategy to expand its portfolio of cancer care products. The acquisition is expected to leverage Helsinn's extensive experience in marketing cancer care products to further grow Valchlor's sales base[1].

Clinical Competitors and Alternatives

Valchlor faces competition from other FDA-approved drugs for CTCL treatment, including Istodax, Uvadex, and Targretin. However, it remains a significant player due to its unique topical formulation and approval for all stages of MF-CTCL[4].

Emerging Competitors: HyBryte™

Soligenix's HyBryte™, a competitor to Valchlor, has shown promising clinical results. A comparability study between HyBryte™ and Valchlor demonstrated a three-fold higher response rate and a better safety profile for HyBryte™. This positions HyBryte™ as a potential front-line treatment for early-stage CTCL, which could impact Valchlor's market share in the future[2].

Financial Trajectory

Revenue and Sales

Valchlor's sales have been a significant contributor to its market presence. The drug's global sales of $35 million in 2017 highlight its financial viability. However, the overall financial trajectory of the companies involved, such as Helsinn and its competitors, can influence Valchlor's market performance.

Cost and Reimbursement

Valchlor benefits from reimbursement by a wide range of public and commercial payers, which has helped in its adoption and sales growth. The cost-effectiveness and reimbursement status are crucial factors in maintaining its market position[1].

Challenges and Opportunities

Limited Treatment Choices

Despite being a rare disease, MF-CTCL has limited treatment choices, which presents an opportunity for Valchlor and other therapies to fill this gap. The lack of curative treatments for CTCL also drives the development of new therapies, potentially impacting Valchlor's market dynamics[4].

Clinical Trials and Development

The ongoing development of new therapies, such as HyBryte™, and the anticipated launch of other CTCL treatments, will continue to shape the market. Companies must focus on cost, efficacy, and safety to maintain or gain market share[4].

Conclusion

Valchlor has established itself as a critical treatment option for MF-CTCL, with a strong sales performance and significant market presence. However, the emergence of competitors like HyBryte™ and the ongoing development of new therapies will continue to influence its market dynamics. The financial trajectory of Valchlor is closely tied to its clinical efficacy, reimbursement status, and the overall market demand for CTCL treatments.

Key Takeaways

• Valchlor is the first and only FDA-approved topical formulation of mechlorethamine for MF-CTCL.
• It has shown significant sales growth since its launch in 2013.
• The drug was acquired by Helsinn Group in 2018 to expand their cancer care portfolio.
• Valchlor faces competition from emerging treatments like HyBryte™.
• The CTCL market is expected to grow, driven by the need for effective and affordable therapies.

FAQs

What is Valchlor used for?

Valchlor is used for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL), a rare type of skin cancer.

Who acquired the worldwide rights to Valchlor?

The Helsinn Group acquired the worldwide rights to Valchlor from Actelion Pharmaceuticals Ltd. in March 2018.

How has Valchlor's sales performance been since its launch?

Valchlor's sales have grown significantly since its launch in 2013, from $11 million in 2014 to $35 million globally in 2017.

What are the emerging competitors to Valchlor?

One of the emerging competitors is Soligenix's HyBryte™, which has shown a three-fold higher response rate and a better safety profile compared to Valchlor in clinical trials.

What is the expected growth rate of the CTCL market?

The CTCL market is expected to grow at a CAGR of 3.7% from 2022 to 2032.

Is Valchlor reimbursed by public and commercial payers?

Yes, Valchlor is reimbursed by a wide range of public and commercial payers, which has contributed to its adoption and sales growth.

Sources

1. Helsinn Group announces agreement to acquire worldwide rights to Valchlor®/Ledaga® - Biospace
2. Soligenix Announces Recent Accomplishments And Second Quarter 2024 Financial Results - Stock Titan
3. Valchlor | Mechlorethamine: Oncology Drug Report 2016 - Business Wire
4. Insights Into The Cutaneous T-cell Lymphoma Treatment Market - DelveInsight
5. Soligenix Announces Recent Accomplishments And Second Quarter 2024 Financial Results - PR Newswire