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Serving 500+ biopharmaceutical companies globally:

US Army
Dow
Queensland Health
Johnson and Johnson
Federal Trade Commission
Colorcon
Baxter
Covington
Moodys
Healthtrust

Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020936

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NDA 020936 describes PAXIL CR, which is a drug marketed by Apotex Technologies and is included in one NDA. It is available from five suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PAXIL CR profile page.

The generic ingredient in PAXIL CR 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 NDA: 020936

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Pharmacology for NDA: 020936

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 020936

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 020936 NDA STAT RX USA LLC 16590-514 16590-514-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-514-30)
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 020936 NDA STAT RX USA LLC 16590-514 16590-514-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-514-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 12.5MG BASE
Approval Date:Feb 16, 1999TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Sep 17, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Jan 19, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Jan 19, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020936

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999► Subscribe► Subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999► Subscribe► Subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000► Subscribe► Subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999► Subscribe► Subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Queensland Health
Argus Health
Teva
Chubb
Moodys
Dow
Harvard Business School
Accenture
McKesson

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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