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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 022029


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NDA 022029 describes SALONPAS, which is a drug marketed by Hisamitsu Pharm Co and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SALONPAS profile page.

The generic ingredient in SALONPAS is menthol; methyl salicylate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the menthol; methyl salicylate profile page.
Summary for 022029
Tradename:SALONPAS
Applicant:Hisamitsu Pharm Co
Ingredient:menthol; methyl salicylate
Patents:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022029
Generic Entry Date for 022029*:
Constraining patent/regulatory exclusivity:
Dosage:
PATCH;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.

Suppliers and Packaging for NDA: 022029
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029 NDA Hisamitsu Pharmaceutical Co., Inc. 46581-670 46581-670-01 1 PATCH in 1 POUCH (46581-670-01)
SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029 NDA Hisamitsu Pharmaceutical Co., Inc. 46581-670 46581-670-03 3 PATCH in 1 POUCH (46581-670-03)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:PATCH;TOPICALStrength3%;10%
Approval Date:Feb 20, 2008TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 3, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Aug 1, 2027Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:PATCH;TOPICALStrength3%;10%
Approval Date:Nov 5, 2012TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 3, 2030Product Flag?YSubstance Flag?Delist Request?

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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.