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Last Updated: March 28, 2024

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-eight 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:48
US Patents:6
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 109
Clinical Trials: 20
Patent Applications: 6,941
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in mechlorethamine hydrochloride?mechlorethamine hydrochloride excipients list
DailyMed Link:mechlorethamine hydrochloride at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for mechlorethamine hydrochloride
Generic Entry Date for mechlorethamine hydrochloride*:
Constraining patent/regulatory exclusivity:
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 mechlorethamine hydrochloride

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

SponsorPhase
Teva Pharmaceuticals USAPhase 2
Seattle Genetics, Inc.Phase 2
Seagen Inc.Phase 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 ⤷  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
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
>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 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
1858864 CR 2017 00033 Denmark ⤷  Try a Trial PRODUCT NAME: CHLORMETHINE, HERUNDER CHLORMETHINE HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1171 20170307
1858864 36/2017 Austria ⤷  Try a Trial PRODUCT NAME: CHLORMETHIN; REGISTRATION NO/DATE: EU/1/16/1171 (MITTEILUNG) 20170307
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.