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Serving leading biopharmaceutical companies globally:

Deloitte
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Julphar
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Generated: December 16, 2017

DrugPatentWatch Database Preview

PAXIL CR Drug Profile

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When do Paxil Cr patents expire, and what generic alternatives are available?

Paxil Cr is a drug marketed by Apotex Technologies and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-five patent family members in forty countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999ABRXYesNo► Subscribe► SubscribeY► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999ABRXYesNo► Subscribe► SubscribeY► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999ABRXYesNo► Subscribe► SubscribeY► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999ABRXYesNo► Subscribe► SubscribeY► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999ABRXYesNo► Subscribe► SubscribeY► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999ABRXYesNo► Subscribe► SubscribeY► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: PAXIL CR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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

International Patent Family for Tradename: PAXIL CR

Country Document Number Estimated Expiration
Cyprus2482► Subscribe
Germany69721756► Subscribe
JapanH11509539► Subscribe
European Patent Office1382337► Subscribe
Japan2000513331► Subscribe
United Kingdom9605828► Subscribe
Peru16098► Subscribe
Denmark0839039► Subscribe
Malaysia141373► Subscribe
South Africa9606148► 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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Serving leading biopharmaceutical companies globally:

Moodys
Argus Health
Cipla
Harvard Business School
Cerilliant
AstraZeneca
Boehringer Ingelheim
McKinsey
Johnson and Johnson
Chubb

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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