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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
McKesson
Queensland Health
Chinese Patent Office
Cipla
Novartis
Federal Trade Commission
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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020885

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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 five 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-three suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

Summary for NDA: 020885

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Summary 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10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:6,063,927*PEDPatent Expiration:Oct 23, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,121,291*PEDPatent Expiration:Sep 17, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:6,172,233*PEDPatent Expiration:Jul 15, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020885

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-001Oct 9, 19985,900,423*PED► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-004Oct 9, 19985,789,449*PED► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-004Oct 9, 19985,900,423*PED► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-002Oct 9, 19985,900,423*PED► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-002Oct 9, 19985,872,132*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Deloitte
Queensland Health
Chinese Patent Office
Farmers Insurance
Harvard Business School
US Army
Medtronic
Express Scripts
Fuji
Moodys

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.

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