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 fifty 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:	50
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:	21
Patent Applications:	6,941
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Soligenix	Phase 2
Teva Pharmaceuticals USA	Phase 2
Seattle Genetics, Inc.	Phase 2

See all mechlorethamine hydrochloride clinical trials

Pharmacology for mechlorethamine hydrochloride

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for mechlorethamine hydrochloride

Alkylating Agents
Antineoplastic Agents, Alkylating
Chemical Warfare Agents
Irritants

US Patents and Regulatory Information for mechlorethamine hydrochloride

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Recordati Rare	MUSTARGEN	mechlorethamine hydrochloride	INJECTABLE;INJECTION	006695-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Country	Patent Number	Title	Estimated Expiration
Japan	5236457		⤷ Sign Up
Denmark	3494960		⤷ Sign Up
Spain	2727523		⤷ Sign Up
Lithuania	PA2017026		⤷ Sign Up
Denmark	2273876		⤷ Sign Up
Poland	3494960		⤷ Sign Up
Portugal	3494960		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for mechlorethamine hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1858864	132017000093882	Italy	⤷ Sign Up	PRODUCT NAME: CLORMETINA(LEDAGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1171, 20170307
1858864	PA2017026	Lithuania	⤷ Sign Up	PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864	17C1029	France	⤷ Sign Up	PRODUCT NAME: CHLORMETHINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER LE CHLORHYDRATE.; REGISTRATION NO/DATE: EU/1/16/1171 20170307
1858864	2017C/033	Belgium	⤷ Sign Up	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1858864	PA2017026,C1858864	Lithuania	⤷ Sign Up	PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
1858864	36/2017	Austria	⤷ Sign Up	PRODUCT NAME: CHLORMETHIN; REGISTRATION NO/DATE: EU/1/16/1171 (MITTEILUNG) 20170307
1858864	C20170027 00259	Estonia	⤷ Sign Up	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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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.