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Generated: November 18, 2018

DrugPatentWatch Database Preview

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. It is available from two suppliers. There are two patents 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. Two suppliers are listed 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:2
Formulation / Manufacturing:see details
Generic Entry Opportunity 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.

Pharmacology for NDA: 022129
Medical Subject Heading (MeSH) Categories for 022129
Suppliers and Packaging for NDA: 022129
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULESFIA benzyl alcohol LOTION;TOPICAL 022129 NDA Zylera Pharmaceuticals, LLC 23594-780 23594-780-08 1 BOTTLE, PLASTIC in 1 CARTON (23594-780-08) > 227 g in 1 BOTTLE, PLASTIC
ULESFIA benzyl alcohol LOTION;TOPICAL 022129 NDA Zylera Pharmaceuticals, LLC 23594-780 23594-780-88 2 BOTTLE, PLASTIC in 1 CARTON (23594-780-88) > 227 g in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength5%
Approval Date:Apr 9, 2009TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 11, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF LICE INFESTATIONS
Patent:➤ Sign UpPatent 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 ➤ 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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Serving hundreds of leading biopharmaceutical companies globally:

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