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

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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020353

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NDA 020353 describes NAPRELAN, which is a drug marketed by Alvogen and is included in one NDA. It is available from three suppliers. Additional details are available on the NAPRELAN profile page.

The generic ingredient in NAPRELAN is naproxen sodium. There are forty-two drug master file entries for this compound. One hundred and thirty-eight suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.
Summary for 020353
Tradename:NAPRELAN
Applicant:Alvogen
Ingredient:naproxen sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020353
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 020353
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353 NDA AUTHORIZED GENERIC Alvogen Inc. 47781-153 47781-153-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-153-01)
NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353 NDA AUTHORIZED GENERIC Alvogen Inc. 47781-154 47781-154-75 75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-154-75)
Paragraph IV (Patent) Challenges for 020353
Tradename Dosage Ingredient NDA Submissiondate
NAPRELAN TABLET, EXTENDED RELEASE;ORAL naproxen sodium 020353

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 375MG BASE
Approval Date:Jan 5, 1996TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 500MG BASE
Approval Date:Jan 5, 1996TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 750MG BASE
Approval Date:Jan 5, 1996TE:ABRLD:Yes

Expired US Patents for NDA 020353

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-001 Jan 5, 1996   Start Trial   Start Trial
Alvogen NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-003 Jan 5, 1996   Start Trial   Start Trial
Alvogen NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-002 Jan 5, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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