Details for New Drug Application (NDA): 202317

✉ Email this page to a colleague

NDA 202317 describes VALCHLOR, which is a drug marketed by Helsinn and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the VALCHLOR profile page.

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.

Summary for 202317

Tradename:	VALCHLOR
Applicant:	Helsinn
Ingredient:	mechlorethamine hydrochloride
Patents:	6

Pharmacology for NDA: 202317

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 202317

Alkylating Agents
Antineoplastic Agents, Alkylating
Chemical Warfare Agents
Irritants

Suppliers and Packaging for NDA: 202317

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317	NDA	Helsinn Therapeutics (U.S.), Inc.	69639-120	69639-120-01	1 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	EQ 0.016% BASE
Approval Date:	Aug 23, 2013	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Mar 7, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Jul 8, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ALKYLATING DRUG INDICATED FOR THE TOPICAL TREATMENT OF STAGE IA AND IB MYCOSIS FUNGOIDES-TYPE CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO HAVE RECEIVED PRIOR SKIN DIRECTED THERAPY
Patent:	⤷ Start Trial	Patent Expiration:	Mar 7, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 202317

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013	⤷ Start Trial	⤷ Start Trial
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013	⤷ Start Trial	⤷ Start Trial
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013	⤷ Start Trial	⤷ Start Trial
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013	⤷ Start Trial	⤷ Start Trial
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.