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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fuji
UBS
Express Scripts
McKesson
Dow
Moodys
Chubb
QuintilesIMS
US Army

Generated: October 21, 2017

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 four 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 forty-seven 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 NDA: 022129

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength5%
Approval Date:Apr 9, 2009TE:RLD:Yes
Patent:► SubscribePatent Expiration:Aug 11, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF LICE INFESTATIONS
Patent:► SubscribePatent Expiration:Aug 11, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF LICE INFESTATIONS
Patent:► SubscribePatent Expiration:Jul 11, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF LICE INFESTATIONS

Expired Orange Book Patents for NDA: 022129

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi Inc
ULESFIA
benzyl alcohol
LOTION;TOPICAL022129-001Apr 9, 2009► Subscribe► Subscribe
Shionogi Inc
ULESFIA
benzyl alcohol
LOTION;TOPICAL022129-001Apr 9, 2009► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Cerilliant
Baxter
Fuji
Novartis
Teva
Medtronic
Queensland Health
Chubb
McKinsey
QuintilesIMS

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