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Last Updated: March 29, 2024

ULESFIA Drug Patent Profile


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Which patents cover Ulesfia, and what generic alternatives are available?

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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 19, 2024. This may change due to patent challenges or generic licensing.

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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  Try a Trial

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

See drug sales revenues for ULESFIA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ULESFIA
Generic Entry Date for ULESFIA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ULESFIA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ULESFIA

Ectoparasite asphyxiator compositions and methods for their application
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  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.