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

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Merck
Johnson and Johnson
Dow
McKesson

Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020031

See Plans and Pricing

« Back to Dashboard

NDA 020031 describes PAXIL, which is a drug marketed by Apotex Technologies and is included in four NDAs. It is available from one supplier. There is one patent 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. Forty-six suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 020031
Tradename:PAXIL
Applicant:Apotex Technologies
Ingredient:paroxetine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020031
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 020031
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAXIL paroxetine hydrochloride TABLET;ORAL 020031 NDA Apotex Corp 60505-3663 60505-3663-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-3663-3)
PAXIL paroxetine hydrochloride TABLET;ORAL 020031 NDA Apotex Corp 60505-3664 60505-3664-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-3664-3)
Paragraph IV (Patent) Challenges for 020031
Tradename Dosage Ingredient NDA Submissiondate
PAXIL TABLET;ORAL paroxetine hydrochloride 020031

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Dec 29, 1992TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Dec 29, 1992TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Dec 29, 1992TE:ABRLD:Yes

Expired US Patents for NDA 020031

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-005 Dec 29, 1992   Start Trial   Start Trial
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-002 Dec 29, 1992   Start Trial   Start Trial
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-002 Dec 29, 1992   Start Trial   Start Trial
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-004 Dec 29, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Merck
Mallinckrodt
Johnson and Johnson
AstraZeneca
Dow

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.