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ULESFIA Drug Profile

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Ulesfia is a drug marketed by Shionogi Inc and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in ULESFIA is benzyl alcohol. There are forty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the benzyl alcohol profile page.

Summary for Tradename: ULESFIA

Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: ULESFIA

Drug ClassPediculicide

Clinical Trials for: ULESFIA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shionogi Inc
benzyl alcohol
LOTION;TOPICAL022129-001Apr 9, 2009RXYes5,858,383Aug 11, 2017
Shionogi Inc
benzyl alcohol
LOTION;TOPICAL022129-001Apr 9, 2009RXYes7,294,342May 19, 2024
Shionogi Inc
benzyl alcohol
LOTION;TOPICAL022129-001Apr 9, 2009RXYes6,139,859Aug 11, 2017
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Paragraph IV activity for: ULESFIA

Drugname Dosage Strength RLD Submissiondate
benzyl alcoholLotion5%Ulesfia4/11/2016
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