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Last Updated: March 3, 2021

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Mechlorethamine hydrochloride - Generic Drug Details

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What are the generic 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 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:40
US Patents:6
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 93
Clinical Trials: 19
Patent Applications: 6,826
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
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 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   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
Helsinn VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes   Start Trial   Start Trial   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 132017000093882 Italy   Start Trial PRODUCT NAME: CLORMETINA(LEDAGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1171, 20170307
1858864 300888 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1858864 PA2017026 Lithuania   Start Trial PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864 2017C/033 Belgium   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1858864 36/2017 Austria   Start Trial PRODUCT NAME: CHLORMETHIN; REGISTRATION NO/DATE: EU/1/16/1171 (MITTEILUNG) 20170307
1858864 295 50013-2017 Slovakia   Start Trial PRODUCT NAME: CHLORMETIN; REGISTRATION NO/DATE: EU/1/16/1171/001 20170306
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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