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

Serving leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
QuintilesIMS
Fish and Richardson
Teva
Citi
Mallinckrodt
Chubb
Healthtrust
Moodys

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020885

« Back to Dashboard

NDA 020885 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-six suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 020885
Tradename:PAXIL
Applicant:Apotex Technologies
Ingredient:paroxetine hydrochloride
Patents:2
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 9, 1998TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 23, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jul 15, 2018Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 9, 1998TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 23, 2019Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020885

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-001 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-001 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-003 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-003 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-003 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-004 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-001 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-001 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
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:

Healthtrust
Mallinckrodt
Farmers Insurance
Cerilliant
Accenture
Harvard Business School
McKinsey
Teva
Express Scripts

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.

botpot