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Mechlorethamine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for mechlorethamine hydrochloride?

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.

This ingredient has twenty patent family members in fifteen countries.

There is one drug master file entry for mechlorethamine hydrochloride. Three suppliers are listed for this compound.

Summary for Generic Name: mechlorethamine hydrochloride

Tradenames:2
Patents:7
Applicants:2
NDAs:2
Drug Master File Entries: see list1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list76
Clinical Trials: see list991
Patent Applications: see list3,083
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:mechlorethamine hydrochloride at DailyMed

Pharmacology for Ingredient: mechlorethamine hydrochloride

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion Pharms Ltd
VALCHLOR
mechlorethamine hydrochloride
GEL;TOPICAL202317-001Aug 23, 2013RXYesYes7,872,050► Subscribe ► Subscribe
Actelion Pharms Ltd
VALCHLOR
mechlorethamine hydrochloride
GEL;TOPICAL202317-001Aug 23, 2013RXYesYes8,501,818► SubscribeY ► Subscribe
Actelion Pharms Ltd
VALCHLOR
mechlorethamine hydrochloride
GEL;TOPICAL202317-001Aug 23, 2013RXYesYes8,450,375► SubscribeY ► Subscribe
Actelion Pharms Ltd
VALCHLOR
mechlorethamine hydrochloride
GEL;TOPICAL202317-001Aug 23, 2013RXYesYes► Subscribe► Subscribe
Recordati Rare
MUSTARGEN
mechlorethamine hydrochloride
INJECTABLE;INJECTION006695-001Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,664,278Stabilized compositions of volatile alkylating agents and methods of using thereof► Subscribe
8,501,817Stabilized compositions of alkylating agents and methods of using same► Subscribe
2,010,029,783► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: mechlorethamine hydrochloride

Country Document Number Estimated Expiration
Japan5671514► Subscribe
Spain2388744► Subscribe
South Korea101168252► Subscribe
New Zealand561268► Subscribe
European Patent Office1858864► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

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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 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.

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