Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Express Scripts
Citi
US Department of Justice
Dow
Harvard Business School
Federal Trade Commission
Baxter

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020710

« Back to Dashboard

NDA 020710 describes PAXIL, which is a drug marketed by Apotex Technologies and is included in four NDAs. It is available from two suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the PAXIL profile page.

The generic ingredient in PAXIL is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 020710
Tradename:PAXIL
Applicant:Apotex Technologies
Ingredient:paroxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details
Pharmacology for NDA: 020710
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 020710
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710 NDA Apotex Corp 60505-0402 N 60505-0402-5

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrengthEQ 10MG BASE/5ML
Approval Date:Jun 25, 1997TE:RLD:Yes

Expired US Patents for NDA 020710

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Department of Justice
Accenture
Teva
Covington
Boehringer Ingelheim
Queensland Health
Harvard Business School
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.