Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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 Cerecor, Inc. 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 Cerecor, Inc. 23594-780 23594-780-88 2 BOTTLE, PLASTIC in 1 CARTON (23594-780-88) > 227 g in 1 BOTTLE, PLASTIC
Paragraph IV (Patent) Challenges for 022129
Tradename Dosage Ingredient NDA Submissiondate
ULESFIA LOTION;TOPICAL benzyl alcohol 022129 2016-04-11

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:LOTION;TOPICALStrength5%
Approval Date:Apr 9, 2009TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jul 11, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF LICE INFESTATIONS
Patent:  Start TrialPatent Expiration:May 19, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF LICE INFESTATIONS

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