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Last Updated: January 30, 2023

Mechlorethamine hydrochloride - Generic Drug Details


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What are the generic drug sources for mechlorethamine hydrochloride and what is the scope of freedom to operate?

Mechlorethamine hydrochloride is the generic ingredient in two branded drugs marketed by Helsinn and Recordati Rare, and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mechlorethamine hydrochloride has forty-seven patent family members in twenty countries.

There is one drug master file entry for mechlorethamine hydrochloride. One supplier is listed for this compound.

Summary for mechlorethamine hydrochloride
International Patents:47
US Patents:6
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 99
Clinical Trials: 20
Patent Applications: 6,777
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in mechlorethamine hydrochloride?mechlorethamine hydrochloride excipients list
DailyMed Link:mechlorethamine hydrochloride at DailyMed
Recent Clinical Trials for mechlorethamine hydrochloride

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

SponsorPhase
Seattle Genetics, Inc.Phase 2
Seagen Inc.Phase 2
Teva Pharmaceuticals USAPhase 2

See all mechlorethamine hydrochloride clinical trials

Pharmacology for mechlorethamine hydrochloride
Drug Class Alkylating Drug
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for mechlorethamine hydrochloride

US Patents and Regulatory Information for mechlorethamine hydrochloride

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 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
Recordati Rare MUSTARGEN mechlorethamine hydrochloride INJECTABLE;INJECTION 006695-001 Approved Prior to Jan 1, 1982 DISCN Yes No 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
>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 mechlorethamine hydrochloride

Country Patent Number Title Estimated Expiration
Croatia P20210283 See Plans and Pricing
European Patent Office 1858864 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) See Plans and Pricing
Japan 5236457 See Plans and Pricing
South Korea 101168252 See Plans and Pricing
Poland 2273876 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for mechlorethamine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1858864 300888 Netherlands See Plans and Pricing PRODUCT NAME: CHLORMETHINE, ALSMEDE DE THERAPEUTISCH EQUIVALENTE VARIANTEN ER VAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/16/1171 20170307
1858864 PA2017026 Lithuania See Plans and Pricing PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864 2017C/033 Belgium See Plans and Pricing DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1858864 PA2017026,C1858864 Lithuania See Plans and Pricing PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864 122017000059 Germany See Plans and Pricing PRODUCT NAME: CHLORMETHIN; REGISTRATION NO/DATE: EU/1/16/1171 20170303
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Express Scripts

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.