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Last Updated: February 25, 2024

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-eight 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 Loss of Exclusivity (LOE) 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 ClassAlkylating 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stabilized compositions of volatile alkylating agents and methods of using thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stabilized compositions of alkylating agents and methods of using same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stabilized compositions of volatile alkylating agents and methods of using thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Helsinn VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Helsinn VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Helsinn VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Helsinn VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Canada

Patent: 00468
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1175735
Estimated Expiration: ⤷  Try a Trial

Patent: 2036557
Estimated Expiration: ⤷  Try a Trial

Patent: 7149591
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0190551
Estimated Expiration: ⤷  Try a Trial

Patent: 0210283
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 13305
Estimated Expiration: ⤷  Try a Trial

Patent: 23974
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 58864
Estimated Expiration: ⤷  Try a Trial

Patent: 73876
Estimated Expiration: ⤷  Try a Trial

Patent: 94960
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 58864
Estimated Expiration: ⤷  Try a Trial

Patent: 73876
Estimated Expiration: ⤷  Try a Trial

Patent: 94960
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 19675
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 43767
Estimated Expiration: ⤷  Try a Trial

Patent: 53482
Estimated Expiration: ⤷  Try a Trial

Patent: 700033
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 36457
Estimated Expiration: ⤷  Try a Trial

Patent: 71514
Estimated Expiration: ⤷  Try a Trial

Patent: 08533152
Estimated Expiration: ⤷  Try a Trial

Patent: 13091643
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 858864
Estimated Expiration: ⤷  Try a Trial

Patent: 2017026
Estimated Expiration: ⤷  Try a Trial

Patent: 73876
Estimated Expiration: ⤷  Try a Trial

Patent: 94960
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 0033
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1268
Estimated Expiration: ⤷  Try a Trial

Patent: 9188
Estimated Expiration: ⤷  Try a Trial

Patent: 9001
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 58864
Estimated Expiration: ⤷  Try a Trial

Patent: 73876
Estimated Expiration: ⤷  Try a Trial

Patent: 94960
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 58864
Estimated Expiration: ⤷  Try a Trial

Patent: 73876
Estimated Expiration: ⤷  Try a Trial

Patent: 94960
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 58864
Estimated Expiration: ⤷  Try a Trial

Patent: 73876
Estimated Expiration: ⤷  Try a Trial

Patent: 94960
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1168252
Estimated Expiration: ⤷  Try a Trial

Patent: 070120163
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 88744
Estimated Expiration: ⤷  Try a Trial

Patent: 27523
Estimated Expiration: ⤷  Try a Trial

Patent: 48841
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1907794
Estimated Expiration: ⤷  Try a Trial

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
Denmark 1858864 ⤷  Try a Trial
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) ⤷  Try a Trial
Spain 2848841 ⤷  Try a Trial
Japan 5236457 ⤷  Try a Trial
Spain 2727523 ⤷  Try a Trial
>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 ⤷  Try a Trial PRODUCT NAME: CHLORMETHINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER LE CHLORHYDRATE.; REGISTRATION NO/DATE: EU/1/16/1171 20170307
1858864 PA2017026,C1858864 Lithuania ⤷  Try a Trial PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864 132017000093882 Italy ⤷  Try a Trial PRODUCT NAME: CLORMETINA(LEDAGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1171, 20170307
1858864 LUC00033 Luxembourg ⤷  Try a Trial PRODUCT NAME: CHLORMETHINE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (LEDAGA); AUTHORISATION NUMBER AND DATE: EU/1/1671171 20170307
1858864 300888 Netherlands ⤷  Try a Trial PRODUCT NAME: CHLORMETHINE, ALSMEDE DE THERAPEUTISCH EQUIVALENTE VARIANTEN ER VAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/16/1171 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.