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PAXIL CR Drug Profile

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Paxil Cr is a drug marketed by Apotex Technologies and is included in one NDA. It is available from five suppliers. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and sixty-one patent family members in fifty-six countries.

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

Summary for Tradename: PAXIL CR

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list5
Drug Prices: :see details

Pharmacology for Tradename: PAXIL CR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999RXNo5,872,132*PED► subscribe ► subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000RXYes7,229,640*PED► subscribeY► subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999RXNo5,872,132*PED► subscribe ► subscribe
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Expired Patents for Tradename: PAXIL CR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 19995,900,423*PED► subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 19995,789,449*PED► subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 20005,872,132*PED► subscribe
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Paragraph IV activity for: PAXIL CR

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

Non-Orange Book Patents for Tradename: PAXIL CR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,856,493 Process for making novel form of paroxeting hydrochloride anhydrate► subscribe
6,080,759 Paroxetine hydrochloride form A► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: PAXIL CR

Country Document Number Estimated Expiration
Poland324553► subscribe
Morocco23942► subscribe
Brazil9609857► 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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