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Last Updated: September 30, 2022

VALCHLOR Drug Patent Profile


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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 forty-seven 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

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Summary for VALCHLOR
Drug patent expirations by year for VALCHLOR
Drug Prices for VALCHLOR

See drug prices for VALCHLOR

DrugPatentWatch® Estimated Generic Entry Opportunity Date for VALCHLOR
Generic Entry Date for VALCHLOR*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Centre for Human Drug Research, NetherlandsN/A
Recordati Rare DiseasesN/A
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhase 2

See all VALCHLOR clinical trials

Pharmacology for VALCHLOR
Drug Class Alkylating Drug
Mechanism of ActionAlkylating Activity

US Patents and Regulatory Information for VALCHLOR

VALCHLOR is protected by six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VALCHLOR is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting VALCHLOR

Stabilized compositions of volatile alkylating agents and methods of using thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stabilized compositions of volatile alkylating agents and methods of using thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Stabilized compositions of volatile alkylating agents and methods of using thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stabilized compositions of alkylating agents and methods of using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stabilized compositions of volatile alkylating agents and methods of using thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Stabilized compositions of volatile alkylating agents and methods of using thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Helsinn VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Helsinn VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 06223076
Estimated Expiration: See Plans and Pricing

Canada

Patent: 00468
Estimated Expiration: See Plans and Pricing

China

Patent: 1175735
Estimated Expiration: See Plans and Pricing

Patent: 2036557
Estimated Expiration: See Plans and Pricing

Patent: 7149591
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0190551
Estimated Expiration: See Plans and Pricing

Patent: 0210283
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 13305
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 58864
Estimated Expiration: See Plans and Pricing

Patent: 73876
Estimated Expiration: See Plans and Pricing

Patent: 94960
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 58864
Estimated Expiration: See Plans and Pricing

Patent: 73876
Estimated Expiration: See Plans and Pricing

Patent: 94960
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 19675
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 43767
Estimated Expiration: See Plans and Pricing

Patent: 53482
Estimated Expiration: See Plans and Pricing

Patent: 700033
Estimated Expiration: See Plans and Pricing

Japan

Patent: 36457
Estimated Expiration: See Plans and Pricing

Patent: 71514
Estimated Expiration: See Plans and Pricing

Patent: 08533152
Estimated Expiration: See Plans and Pricing

Patent: 13091643
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 858864
Estimated Expiration: See Plans and Pricing

Patent: 2017026
Estimated Expiration: See Plans and Pricing

Patent: 73876
Estimated Expiration: See Plans and Pricing

Patent: 94960
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0033
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1268
Estimated Expiration: See Plans and Pricing

Patent: 9188
Estimated Expiration: See Plans and Pricing

Patent: 9001
Estimated Expiration: See Plans and Pricing

Poland

Patent: 58864
Estimated Expiration: See Plans and Pricing

Patent: 73876
Estimated Expiration: See Plans and Pricing

Patent: 94960
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 58864
Estimated Expiration: See Plans and Pricing

Patent: 73876
Estimated Expiration: See Plans and Pricing

Patent: 94960
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 58864
Estimated Expiration: See Plans and Pricing

Patent: 73876
Estimated Expiration: See Plans and Pricing

Patent: 94960
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1168252
Estimated Expiration: See Plans and Pricing

Patent: 070120163
Estimated Expiration: See Plans and Pricing

Spain

Patent: 88744
Estimated Expiration: See Plans and Pricing

Patent: 27523
Estimated Expiration: See Plans and Pricing

Patent: 48841
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1907794
Estimated Expiration: See Plans and Pricing

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
Croatia P20210283 See Plans and Pricing
Denmark 2273876 See Plans and Pricing
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) See Plans and Pricing
Cyprus 1113305 See Plans and Pricing
Japan 2013091643 STABILIZED COMPOSITION OF VOLATILE ALKYLATING AGENT AND METHOD FOR USING THEREOF See Plans and Pricing
Spain 2848841 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VALCHLOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1858864 17C1029 France See Plans and Pricing PRODUCT NAME: CHLORMETHINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER LE CHLORHYDRATE.; REGISTRATION NO/DATE: EU/1/16/1171 20170307
1858864 PA2017026,C1858864 Lithuania See Plans and Pricing PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864 295 50013-2017 Slovakia See Plans and Pricing PRODUCT NAME: CHLORMETIN; REGISTRATION NO/DATE: EU/1/16/1171/001 20170306
1858864 PA2017026 Lithuania See Plans and Pricing PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864 C20170027 00259 Estonia See Plans and Pricing PRODUCT NAME: KLOORMETIIN;REG NO/DATE: EU/1/16/1171 07.03.2017
1858864 36/2017 Austria See Plans and Pricing PRODUCT NAME: CHLORMETHIN; REGISTRATION NO/DATE: EU/1/16/1171 (MITTEILUNG) 20170307
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Baxter
Colorcon
Mallinckrodt
AstraZeneca

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. 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.