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Last Updated: September 27, 2020

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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 thirty-nine 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
Recent Clinical Trials for mechlorethamine hydrochloride

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

Seattle Genetics, Inc.Phase 2
Teva Pharmaceuticals USAPhase 2
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhase 2

See all mechlorethamine hydrochloride clinical trials

Pharmacology for mechlorethamine hydrochloride
Drug ClassAlkylating 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   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
>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 mechlorethamine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1858864 2017C/033 Belgium   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1858864 C20170027 00259 Estonia   Start Trial PRODUCT NAME: KLOORMETIIN;REG NO/DATE: EU/1/16/1171 07.03.2017
1858864 CR 2017 00033 Denmark   Start Trial PRODUCT NAME: CHLORMETHINE, HERUNDER CHLORMETHINE HYDROCHLORIDE; REG. 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:

Boehringer Ingelheim
Harvard Business School
Express Scripts

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