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PAXIL Drug Profile

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Which patents cover Paxil, and what substitute generic drugs are available?

Paxil is a drug marketed by Apotex Technologies and is included in four NDAs. There are five patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and fifty-eight patent family members in thirty-nine countries.

The generic ingredient in PAXIL is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

Summary for Tradename: PAXIL

Patents:3
Applicants:1
NDAs:4
Suppliers / Packagers: see list2
Bulk Api Vendors: see list41
Clinical Trials: see list28
Patent Applications: see list5,881
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:PAXIL at DailyMed

Pharmacology for Tradename: PAXIL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Technologies
PAXIL
paroxetine hydrochloride
SUSPENSION;ORAL020710-001Jun 25, 1997RXYesYes6,121,291*PED► SubscribeY► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-004Oct 9, 1998DISCNYesNo6,172,233*PED► SubscribeY► Subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999RXYesNo7,229,640*PED► SubscribeY► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-001Oct 9, 1998DISCNYesNo6,063,927*PED► SubscribeY► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-003Dec 29, 1992RXYesNo6,121,291*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: PAXIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-002Oct 9, 19984,721,723*PED► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-002Dec 29, 19925,789,449*PED► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-003Dec 29, 19925,789,449*PED► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-002Oct 9, 19985,872,132*PED► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-004Dec 29, 19926,133,289*PED► Subscribe
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Paragraph IV activity for: PAXIL

Drugname Dosage Strength RLD Submissiondate
paroxetine hydrochlorideExtended-release Tablets37.5 mgPaxil CR5/19/2009
paroxetine hydrochlorideExtended-release Tablets25 mgPaxil CR9/9/2005
paroxetine hydrochlorideOral Suspension10 mg/5 mLPaxil2/10/2005

International Patent Family for Tradename: PAXIL

Country Document Number Estimated Expiration
United Kingdom2339428► Subscribe
Brazil9911679► Subscribe
Finland990190► Subscribe
South Africa9907477► Subscribe
World Intellectual Property Organization (WIPO)0001694► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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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