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.

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

Indicators of Generic Entry

Summary for VALCHLOR

US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	8
Patent Applications:	5,555
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

Recent Clinical Trials for VALCHLOR

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

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

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
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
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			Y

Expired US Patents for VALCHLOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013

International Patents for VALCHLOR

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

Country	Patent Number	Title	Estimated Expiration
Australia	2006223076	Stabilized compositions of volatile alkylating agents and methods of using thereof
Canada	2600468	COMPOSITIONS STABILISEES D'AGENTS D'ALKYLATION VOLATILS ET METHODES D'UTILISATION DE CES COMPOSITIONS (STABILIZED COMPOSITIONS OF VOLATILE ALKYLATING AGENTS AND METHODS OF USING THEREOF)
China	101175735	Stabilized compositions of volatile alkylating agents and methods of using thereof
China	102036557	Stabilized compositions of alkylating agents and methods of using same
China	107149591	烷基化剂的稳定组合物及其使用方法 (Stabilized compositions of volatile alkylating agents and methods of using thereof)
Cyprus	1113305

Supplementary Protection Certificates for VALCHLOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1858864	PA2017026	Lithuania		PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864	CR 2017 00033	Denmark		PRODUCT NAME: CHLORMETHINE, HERUNDER CHLORMETHINE HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1171 20170307
1858864	300888	Netherlands		PRODUCT NAME: CHLORMETHINE, ALSMEDE DE THERAPEUTISCH EQUIVALENTE VARIANTEN ER VAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/16/1171 20170307
1858864	122017000059	Germany		PRODUCT NAME: CHLORMETHIN; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864	36/2017	Austria		PRODUCT NAME: CHLORMETHIN; REGISTRATION NO/DATE: EU/1/16/1171 (MITTEILUNG) 20170307
1858864	LUC00033	Luxembourg		PRODUCT NAME: CHLORMETHINE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (LEDAGA); AUTHORISATION NUMBER AND DATE: EU/1/1671171 20170307

Last updated: July 15, 2026

VALCHLOR (vals tchl or) market dynamics and financial trajectory: exclusivity, generic and settlement risks, and payer impact

VALCHLOR (valchlor, mechlorethamine gel 0.016%) is a single-asset dermatology product with a constrained addressable population (cutaneous T-cell lymphoma, specifically facial involvement and limited-stage disease). Its commercial trajectory has been shaped by (1) narrow FDA-labeled use, (2) distribution and reimbursement friction typical for specialty topical oncology, and (3) a patent and exclusivity posture that has left the product exposed to competitive entry pressure even as litigation outcomes determine timing.

What is VALCHLOR’s FDA status and labeled use driving uptake?

What does VALCHLOR treat under the FDA label?

VALCHLOR (mechlorethamine hydrochloride, topical gel 0.016%) is indicated for the topical treatment of cutaneous T-cell lymphoma (CTCL) in patients with mycosis fungoides affecting the facial area. The label restricts use to a defined clinical context, limiting addressable patient numbers compared with broader dermatology oncology products.

What FDA pathway and regulatory milestones matter for competition?

VALCHLOR is an FDA-approved topical oncology product; entry risk is downstream of regulatory status, Orange Book listing, and patent expiry and exclusivity events rather than new-review pathway dynamics. The key commercial relevance for investors and licensors is that:

• generic topical oncology launches require ANDA eligibility for the labeled drug product and conditions;
• biosimilar frameworks are not applicable (small molecule topical);
• third-party challenge risk is tied to Orange Book patent counts and their expiration schedules.

How does VALCHLOR’s market size and payer coverage affect revenue?

What is the addressable market constraint for a topical CTCL therapy?

CTCL is relatively rare compared with common dermatology indications. Within CTCL, the facial involvement subset further tightens use. That combination typically produces:

• a smaller prescriber base,
• slower patient conversion to therapy,
• higher per-patient treatment intensity in pharmacy and prior authorization workflows.

What payer dynamics tend to dominate VALCHLOR’s financial performance?

Specialty topical oncology products face reimbursement friction through:

• prior authorization requirements,
• coverage edits tied to documentation of facial involvement,
• step therapy or “trial of alternatives” processes in some commercial plans,
• lower utilization versus systemic CTCL drugs where those are covered and clinically preferred.

What procurement and channel dynamics likely impact pricing and net sales?

For a niche topical oncology product, revenue is highly sensitive to:

• channel stocking decisions by specialty distributors,
• contract pharmacy placement and formulary inclusion,
• seasonal and clinic-driven prescribing patterns rather than broad retail demand.

What patents protect VALCHLOR and how strong is the patent estate?

How many patents cover VALCHLOR on the Orange Book?

VALCHLOR’s competitive posture depends on Orange Book-listed patents for the drug substance, formulation, and use. This is the primary determinant of whether ANDA filers can enter before the legal expiry window closes.

What patent types usually matter most for a topical oncology gel?

In topical oncology, the patent stack typically includes:

• composition of matter (drug substance or key formulation components),
• formulation-specific patents (gel matrix, concentrations, stabilizers),
• method-of-use patents tied to indication and dosing regimen.

What does patent strength mean for generic entry risk?

The stronger the composition-of-matter and formulation coverage, the lower the probability of “design-around” entry by generic applicants. A weaker formulation or use-only patent profile increases the chance of earlier launch via an ANDA carveout if a paragraph IV is successful.

When does VALCHLOR lose exclusivity and what are the key expiration dates?

How do exclusivity and patent expiry interact for VALCHLOR?

Generic timing for VALCHLOR is governed by:

1. the expiration of the last Orange Book patent that blocks ANDA approval for the reference product as listed for the relevant label,
2. any applicable exclusivity periods that extend legal protection beyond patent expiry.

For a niche therapy, even a small delay in the last blocking event can materially shift revenue because the product lacks broad market volume.

Which companies are challenging VALCHLOR with Paragraph IV and what do litigation outcomes mean?

What is the usual pattern of Paragraph IV for specialty topical drugs?

An ANDA challenger typically files a paragraph IV certification to assert non-infringement or invalidity for one or more Orange Book patents. For VALCHLOR, the financial relevance is direct:

• a successful first challenger can shift revenue from incumbents quickly due to small patient pools and high substitution rates among remaining prescribers once coverage permits generic access;
• an unfavorable outcome can delay generic launches by years and raise the challenger’s sunk-cost profile.

What litigation and settlements usually drive the commercial timeline?

For branded specialty drugs, settlements often involve:

• agreed effective dates of generic launch,
• license terms or ongoing royalty structures,
• stipulations that can determine whether a challenger can launch at launch date or at risk.

The commercial result is typically a discrete step-change in market access for the branded product once the generic comes in.

What is the generic and biosimilar risk profile for VALCHLOR?

Are biosimilars applicable to VALCHLOR?

No. VALCHLOR is a small-molecule topical product; competitive risk is from generics and potentially authorized generics rather than biosimilars.

What generic entry scenarios matter most financially?

The highest-impact scenarios are:

• early launch if the last blocking patent is found invalid or not infringed,
• delayed launch if the court enjoins the challenger,
• “at-risk” launch by a challenger if settlement does not occur.

Because the addressable market is small, substitution can be disproportionately fast once a covered generic is available.

How does VALCHLOR’s financial trajectory compare with other CTCL therapies?

What does comparison look like across specialty oncology dermatology?

Compared with systemic CTCL therapies, VALCHLOR has:

• lower total addressable revenue due to topical-only indication constraints,
• narrower prescriber and patient conversion funnel,
• higher sensitivity to reimbursement and formulary changes.

When systemic competitors expand indications or gain payer preference, the topical incumbent often faces share loss that is not easily offset by price increases.

What matters more: volume or price for VALCHLOR?

For niche topical oncology products, net sales often depend more on:

• units dispensed and persistence,
• payer access (coverage and copays),
• specialty channel placement.

Net pricing changes can occur but are less able to offset volume declines if the payer list narrows.

What commercialization factors affect VALCHLOR: product supply, adherence, and adoption?

How does treatment regimen complexity impact usage?

Topical oncology gels typically require:

• consistent application,
• careful handling and patient education,
• adherence monitoring.

Lower adherence reduces effective use conversion, which can translate to modest prescribing volumes even when clinical uptake exists.

How do safety and tolerability considerations affect market penetration?

Topical mechlorethamine can cause local irritation and treatment discontinuation risks. That influences:

• prescriber comfort,
• patient selection,
• willingness to maintain therapy long-term.

In niche oncology, such discontinuation can materially affect refill-driven revenue.

What patent litigation affects VALCHLOR market access and contract terms?

How do court outcomes translate to market timing?

A typical revenue-impact sequence is:

1. ANDA filing triggers litigation or potential settlement negotiations;
2. court decisions or settlements determine whether launch is enjoined or permitted;
3. launch triggers competitive pricing pressure and payer re-optimization;
4. branded net sales compress due to channel conversion to the cheaper alternative.

For VALCHLOR, the scale of revenue means that even a late single-digit percent conversion shift can be material.

What are VALCHLOR’s commercial milestones and revenue drivers over time?

What drives quarterly net sales volatility for niche oncology products?

Common drivers include:

• patient starts and therapy duration,
• formulary changes and prior authorization outcomes,
• inventory timing at specialty distributors,
• substitution dynamics as generic/authorized generic timelines approach.

What are the “leading indicators” for revenue in a topical CTCL product?

The most predictive indicators typically are:

• new patient starts at dermatology oncology centers,
• refill persistence rates,
• formulary status at large pharmacy benefit managers.

Key Takeaways

• VALCHLOR’s financial trajectory is dominated by its narrow labeled population in CTCL facial involvement and by payer and reimbursement friction typical of specialty topical oncology.
• Generic competition risk is determined by Orange Book-listed patents and any associated exclusivity, not by pathway mechanics.
• Litigation and settlement outcomes are the key timing levers that can cause step-changes in branded revenue via generic substitution in a small patient pool.
• For investors and licensors, VALCHLOR is best modeled as a niche specialty product where formulary access and legal-competition timing drive financial outcomes more than price moves.

FAQs

1. What Orange Book patents block generic ANDA approval for VALCHLOR and which expire first?
2. Which Paragraph IV certifications have been filed against VALCHLOR and on what patent numbers?
3. What settlement terms are typical in VALCHLOR-style specialty topical oncology cases, and how do they affect generic launch dates?
4. How do payer prior authorization and formulary edits typically impact net sales for topical oncology drugs like VALCHLOR?
5. What generic entry scenarios create the fastest brand revenue decline for niche CTCL therapies?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA Label. VALCHLOR (mechlorethamine hydrochloride) topical gel prescribing information. U.S. Food and Drug Administration.

DrugChatter Q&A for VALCHLOR

What is valchlor?