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Paroxetine hydrochloride - Generic Drug Details

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Paroxetine hydrochloride is the generic ingredient in four branded drugs marketed by Mylan, Aurobindo Pharma, Apotex Technologies, Mylan Pharms Inc, Teva, Roxane, Jubilant Generics, Kremers Urban Pharms, Prinston Inc, Apotex, Sandoz, Oxford Pharms, Teva Pharms, Zydus Pharms Usa, Sun Pharm Inds Inc, and Apotex Inc, and is included in twenty-one NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and fifty-six patent family members in fifty-seven countries.

There are twenty-nine drug master file entries for paroxetine hydrochloride. Fifty-one suppliers are listed for this compound.

Summary for Generic Name: paroxetine hydrochloride

Tradenames:4
Patents:10
Applicants:16
NDAs:21
Drug Master File Entries: see list29
Suppliers / Packaging: see list51
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: paroxetine hydrochloride

Clinical Trials for: paroxetine hydrochloride

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;ORAL020936-003Dec 6, 2000RXYes5,900,423*PEDNov 19, 2015
Sandoz
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL075566-003Mar 8, 2004DISCNNo
Roxane
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL078026-001Jun 29, 2007DISCNNo
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Expired Orange Book Patents for Generic Ingredient: paroxetine hydrochloride

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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;ORAL020936-003Dec 6, 20005,422,123*PED<disabled>
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-003Oct 9, 19986,080,759*PED<disabled>
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-001Dec 29, 19926,113,944*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: paroxetine hydrochloride

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>
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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 Ingredient: paroxetine hydrochloride

Country Document Number Estimated Expiration
Morocco23942<disabled in preview>
Bulgaria100333<disabled in preview>
Austria3185<disabled in preview>
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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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