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Last Updated: January 24, 2020

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Menthol; methyl salicylate - Generic Drug Details

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What are the generic sources for menthol; methyl salicylate and what is the scope of freedom to operate?

Menthol; methyl salicylate is the generic ingredient in one branded drug marketed by Hisamitsu Pharm Co and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Menthol; methyl salicylate has eighteen patent family members in fourteen countries.

There are eighteen drug master file entries for menthol; methyl salicylate. One supplier is listed for this compound.

Summary for menthol; methyl salicylate
International Patents:18
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 18
Suppliers / Packagers: 1
Clinical Trials: 6
DailyMed Link:menthol; methyl salicylate at DailyMed
Recent Clinical Trials for menthol; methyl salicylate

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

SponsorPhase
University of Santiago de CompostelaPhase 4
GlaxoSmithKlinePhase 4
University of Ljubljana, Faculty of MedicineN/A

See all menthol; methyl salicylate clinical trials

US Patents and Regulatory Information for menthol; methyl salicylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-002 Nov 5, 2012 OTC Yes No   Start Trial   Start Trial Y   Start Trial
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-001 Feb 20, 2008 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-002 Nov 5, 2012 OTC Yes No   Start Trial   Start Trial Y   Start Trial
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-001 Feb 20, 2008 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Merck
Johnson and Johnson
Harvard Business School
Colorcon

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