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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208694

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NDA 208694 describes ZERVIATE, which is a drug marketed by Eyevance and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ZERVIATE profile page.

The generic ingredient in ZERVIATE is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 208694
Ingredient:cetirizine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 208694
Medical Subject Heading (MeSH) Categories for 208694
Suppliers and Packaging for NDA: 208694
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZERVIATE cetirizine hydrochloride SOLUTION/DROPS;OPHTHALMIC 208694 NDA Eyevance Pharmaceuticals 71776-024 71776-024-01 5 VIAL, SINGLE-USE in 1 CARTON (71776-024-01) > .2 mL in 1 VIAL, SINGLE-USE
ZERVIATE cetirizine hydrochloride SOLUTION/DROPS;OPHTHALMIC 208694 NDA Eyevance Pharmaceuticals 71776-024 71776-024-05 1 BOTTLE, DROPPER in 1 CARTON (71776-024-05) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.24% BASE
Approval Date:May 30, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:May 30, 2020
Regulatory Exclusivity Use:NEW DOSAGE FORM
Regulatory Exclusivity Expiration:Nov 30, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:  Start TrialPatent Expiration:Sep 15, 2030Product Flag?Substance Flag?Delist Request?Y

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Harvard Business School

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