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Last Updated: November 2, 2024

ULESFIA Drug Patent Profile


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Which patents cover Ulesfia, and when can generic versions of Ulesfia launch?

Ulesfia 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.

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.

DrugPatentWatch® Generic Entry Outlook for Ulesfia

Ulesfia was eligible for patent challenges on April 9, 2013.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for ULESFIA
Drug patent expirations by year for ULESFIA
Drug Sales Revenue Trends for ULESFIA

See drug sales revenues for ULESFIA

Recent Clinical Trials for ULESFIA

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

SponsorPhase
South Florida Family Health and Research CentersPhase 3
Axis Clinical TrialsPhase 3
Akorn, Inc.Phase 3

See all ULESFIA clinical trials

Paragraph IV (Patent) Challenges for ULESFIA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ULESFIA Lotion benzyl alcohol 5% 022129 1 2016-04-11

US Patents and Regulatory Information for ULESFIA

ULESFIA is protected by one US patents.

Patents protecting ULESFIA

Ectoparasite asphyxiator compositions and methods for their application
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TOPICAL TREATMENT OF LICE INFESTATIONS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 DISCN Yes No ⤷  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

Expired US Patents for ULESFIA

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

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