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: November 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209090

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NDA 209090 describes XYZAL ALLERGY 24HR, which is a drug marketed by Sanofi Aventis Us and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the XYZAL ALLERGY 24HR profile page.

The generic ingredient in XYZAL ALLERGY 24HR is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 209090
Tradename:XYZAL ALLERGY 24HR
Applicant:Sanofi Aventis Us
Ingredient:levocetirizine dihydrochloride
Patents:1
Suppliers and Packaging for NDA: 209090
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XYZAL ALLERGY 24HR levocetirizine dihydrochloride SOLUTION;ORAL 209090 NDA Chattem, Inc. 41167-3530 41167-3530-1 1 BOTTLE in 1 CARTON (41167-3530-1) > 148 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 209090
Tradename Dosage Ingredient NDA Submissiondate
XYZAL ALLERGY 24HR SOLUTION;ORAL levocetirizine dihydrochloride 209090 2018-01-04

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;ORALStrength2.5MG/5ML
Approval Date:Jan 31, 2017TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 16, 2027Product Flag?YSubstance Flag?Delist Request?

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