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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 twenty-nine drug master file entries for this compound. Fifty-one 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

Pharmacology for Tradename: PAXIL CR

Clinical Trials for: 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, 1999RXNo7,229,640*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000RXYes5,872,132*PED<disabled> <disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999RXNo7,229,640*PED<disabled>Y<disabled>
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Expired Patents for Tradename: PAXIL CR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 19995,789,449*PED<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 19995,422,123*PED<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 19995,872,132*PED<disabled>
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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<disabled in preview>
6,080,759 Paroxetine hydrochloride form A<disabled in preview>
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International Patent Family for Tradename: PAXIL CR

Country Document Number Estimated Expiration
African Intellectual Property Organization (OAPI)10652<disabled in preview>
Canada2210022<disabled in preview>
Spain2114471<disabled in preview>
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