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 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020487

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NDA 020487 describes VALTREX, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from three suppliers. Additional details are available on the VALTREX profile page.

The generic ingredient in VALTREX is valacyclovir hydrochloride. There are twenty-three drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.
Summary for 020487
Tradename:VALTREX
Applicant:Glaxosmithkline
Ingredient:valacyclovir hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020487
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 020487
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALTREX valacyclovir hydrochloride TABLET;ORAL 020487 NDA GlaxoSmithKline LLC 0173-0565 0173-0565-04 30 TABLET, FILM COATED in 1 BOTTLE (0173-0565-04)
VALTREX valacyclovir hydrochloride TABLET;ORAL 020487 NDA GlaxoSmithKline LLC 0173-0565 0173-0565-10 90 TABLET, FILM COATED in 1 BOTTLE (0173-0565-10)
Paragraph IV (Patent) Challenges for 020487
Tradename Dosage Ingredient NDA Submissiondate
VALTREX TABLET;ORAL valacyclovir hydrochloride 020487

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Jun 23, 1995TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1GM BASE
Approval Date:Jun 23, 1995TE:ABRLD:Yes

Expired US Patents for NDA 020487

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Moodys

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