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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 022129


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NDA 022129 describes ULESFIA, which is a drug marketed by Shionogi Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ULESFIA profile page.

The generic ingredient in ULESFIA is benzyl alcohol. There are fifty drug master file entries for this compound. Additional details are available on the benzyl alcohol profile page.
Summary for 022129
Tradename:ULESFIA
Applicant:Shionogi Inc
Ingredient:benzyl alcohol
Patents:1
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022129
Generic Entry Date for 022129*:
Constraining patent/regulatory exclusivity:
Dosage:
LOTION;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.

Medical Subject Heading (MeSH) Categories for 022129

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:LOTION;TOPICALStrength5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 9, 2009TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:May 19, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF LICE INFESTATIONS

Expired US Patents for NDA 022129

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 ⤷  Try a Trial ⤷  Try a Trial
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 ⤷  Try a Trial ⤷  Try a Trial
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.