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Last Updated: October 31, 2020

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VALCHLOR Drug 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 thirty-nine 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.

US ANDA Litigation and 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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Drug patent expirations by year for VALCHLOR
Drug Prices for VALCHLOR

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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
Mayo ClinicPhase 2
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhase 2
National Institutes of Health (NIH)Phase 0

See all VALCHLOR clinical trials

Pharmacology for VALCHLOR
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

US Patents and Regulatory Information for VALCHLOR

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

Supplementary Protection Certificates for VALCHLOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1858864 17C1029 France   Start Trial PRODUCT NAME: CHLORMETHINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER LE CHLORHYDRATE.; REGISTRATION NO/DATE: EU/1/16/1171 20170307
1858864 132017000093882 Italy   Start Trial PRODUCT NAME: CLORMETINA(LEDAGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1171, 20170307
1858864 PA2017026 Lithuania   Start Trial PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864 36/2017 Austria   Start Trial PRODUCT NAME: CHLORMETHIN; REGISTRATION NO/DATE: EU/1/16/1171 (MITTEILUNG) 20170307
1858864 122017000059 Germany   Start Trial PRODUCT NAME: CHLORMETHIN; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864 300888 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1858864 C20170027 00259 Estonia   Start Trial PRODUCT NAME: KLOORMETIIN;REG NO/DATE: EU/1/16/1171 07.03.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.