Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
Merck
Farmers Insurance
Deloitte
Chubb
UBS
Argus Health
Healthtrust
Citi
Accenture

Generated: February 19, 2018

DrugPatentWatch Database Preview

Mechlorethamine hydrochloride - Generic Drug Details

« Back to Dashboard

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

Mechlorethamine hydrochloride
is the generic ingredient in two branded drugs marketed by Actelion Pharms Ltd 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 twenty-seven patent family members in seventeen countries.

There is one drug master file entry for mechlorethamine hydrochloride. Two suppliers are listed for this compound.
Summary for mechlorethamine hydrochloride
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
Recordati Rare MUSTARGEN mechlorethamine hydrochloride INJECTABLE;INJECTION 006695-001 Approved Prior to Jan 1, 1982 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actelion Pharms Ltd VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Actelion Pharms Ltd VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actelion Pharms Ltd VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actelion Pharms Ltd VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Actelion Pharms Ltd VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Actelion Pharms Ltd VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317-001 Aug 23, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Actelion Pharms Ltd 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for mechlorethamine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
2,010,029,783 ➤ Sign Up
8,501,817 Stabilized compositions of alkylating agents and methods of using same ➤ Sign Up
8,664,278 Stabilized compositions of volatile alkylating agents and methods of using thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for mechlorethamine hydrochloride

Supplementary Protection Certificates for mechlorethamine hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0888 Netherlands ➤ Sign Up PRODUCT NAME: CHLORMETHINE, ALSMEDE DE THERAPEUTISCH EQUIVALENTE VARIANTEN ER VAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/16/1171 20170307
2017026 Lithuania ➤ Sign Up PRODUCT NAME: CHLORMETINAS; REGISTRATION NO/DATE: EU/1/16/1171 20170303
2017000059 Germany ➤ Sign Up PRODUCT NAME: CHLORMETHIN; REGISTRATION NO/DATE: EU/1/16/1171 20170303
/2017 Austria ➤ Sign Up PRODUCT NAME: CHLORMETHIN; REGISTRATION NO/DATE: EU/1/16/1171 (MITTEILUNG) 20170307
2017 00033 Denmark ➤ Sign Up PRODUCT NAME: CHLORMETHINE, HERUNDER CHLORMETHINE HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1171 20170307
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Accenture
Farmers Insurance
QuintilesIMS
Fish and Richardson
Medtronic
US Army
Queensland Health
Harvard Business School

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 verifification 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.

botpot