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Last Updated: July 12, 2020

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ULESFIA Drug 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 are two patents 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. One supplier is listed for this compound. Additional details are available on the benzyl alcohol profile page.

US ANDA Litigation and 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 July 11, 2022. 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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Drug patent expirations by year for ULESFIA
Drug Sales Revenue Trends for ULESFIA

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

See all ULESFIA clinical trials

Pharmacology for ULESFIA
Drug ClassPediculicide
Paragraph IV (Patent) Challenges for ULESFIA
Tradename Dosage Ingredient NDA Submissiondate
ULESFIA LOTION;TOPICAL benzyl alcohol 022129 2016-04-11

US Patents and Regulatory Information for ULESFIA

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   Start Trial   Start Trial Y   Start Trial
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 DISCN Yes No   Start Trial   Start Trial   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:

Mallinckrodt
Dow
Boehringer Ingelheim
AstraZeneca
Johnson and Johnson
Baxter

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.