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

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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020990

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NDA 020990 describes ZOLOFT, which is a drug marketed by Pfizer and is included in two NDAs. It is available from six suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZOLOFT profile page.

The generic ingredient in ZOLOFT is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
Summary for 020990
Tradename:ZOLOFT
Applicant:Pfizer
Ingredient:sertraline hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 020990
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 020990
Suppliers and Packaging for NDA: 020990
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990 NDA Roerig 0049-0050 0049-0050-01 1 BOTTLE, DROPPER in 1 CARTON (0049-0050-01) > 60 mL in 1 BOTTLE, DROPPER
ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990 NDA AUTHORIZED GENERIC Greenstone LLC 59762-0067 59762-0067-1 60 mL in 1 BOTTLE, DROPPER (59762-0067-1)
Paragraph IV (Patent) Challenges for 020990
Tradename Dosage Ingredient NDA Submissiondate
ZOLOFT CONCENTRATE;ORAL sertraline hydrochloride 020990 2003-12-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrengthEQ 20MG BASE/ML
Approval Date:Dec 7, 1999TE:AARLD:Yes
Patent:  Start TrialPatent Expiration:Apr 11, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Apr 11, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020990

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990-001 Dec 7, 1999   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990-001 Dec 7, 1999   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990-001 Dec 7, 1999   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990-001 Dec 7, 1999   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990-001 Dec 7, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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