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Serving leading biopharmaceutical companies globally:

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Generated: December 17, 2017

DrugPatentWatch Database Preview

Paroxetine hydrochloride - Generic Drug Details

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What are the generic sources for paroxetine hydrochloride and what is the scope of paroxetine hydrochloride freedom to operate?

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

Paroxetine hydrochloride has two hundred and twenty-three patent family members in fifty-one countries.

There are thirty drug master file entries for paroxetine hydrochloride. Fifty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for paroxetine hydrochloride

Tentative approvals for PAROXETINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► SubscribeEQ 10MG BASETABLET;ORAL
u► SubscribeEQ 40MG BASETABLET;ORAL
u► SubscribeEQ 30MG BASETABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
MylanPAROXETINE HYDROCHLORIDEparoxetine hydrochlorideTABLET;ORAL078902-003Mar 13, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncPAROXETINE HYDROCHLORIDEparoxetine hydrochlorideTABLET;ORAL075716-003Mar 8, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Apotex TechnologiesPAXILparoxetine hydrochlorideTABLET;ORAL020031-005Dec 29, 1992ABRXYesYes► Subscribe► SubscribeY► Subscribe
Jubilant GenericsPAROXETINE HYDROCHLORIDEparoxetine hydrochlorideTABLET;ORAL205528-004Nov 27, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms UsaPAROXETINE HYDROCHLORIDEparoxetine hydrochlorideTABLET;ORAL077584-003Mar 7, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex TechnologiesPAXILparoxetine hydrochlorideTABLET;ORAL020031-002Dec 29, 1992ABRXYesNo► Subscribe► SubscribeY► Subscribe
ApotexPAROXETINE HYDROCHLORIDEparoxetine hydrochlorideTABLET;ORAL075356-003Jul 30, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Prinston IncPAROXETINEparoxetine hydrochlorideTABLET;ORAL203854-001Oct 31, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
MylanPAROXETINE HYDROCHLORIDEparoxetine hydrochlorideTABLET;ORAL078902-002Mar 13, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva PharmsPAROXETINE HYDROCHLORIDEparoxetine hydrochlorideTABLET;ORAL077082-002Jun 29, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: paroxetine hydrochloride

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 TechnologiesPAXILparoxetine hydrochlorideTABLET;ORAL020031-003Dec 29, 1992► Subscribe► Subscribe
Apotex TechnologiesPAXILparoxetine hydrochlorideTABLET;ORAL020031-002Dec 29, 1992► Subscribe► Subscribe
Apotex TechnologiesPAXILparoxetine hydrochlorideTABLET;ORAL020031-003Dec 29, 1992► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000► Subscribe► Subscribe
Apotex TechnologiesPAXILparoxetine hydrochlorideCAPSULE;ORAL020885-001Oct 9, 1998► Subscribe► Subscribe
Apotex TechnologiesPAXILparoxetine hydrochlorideTABLET;ORAL020031-004Dec 29, 1992► 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 TechnologiesPAXILparoxetine hydrochlorideCAPSULE;ORAL020885-003Oct 9, 1998► Subscribe► Subscribe
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International Patent Family for Ingredient: paroxetine hydrochloride

Country Document Number Estimated Expiration
Portugal102384► Subscribe
IrelandS990343► Subscribe
Poland184987► Subscribe
Turkey200100054► Subscribe
European Patent Office1064936► Subscribe
European Patent Office1288214► Subscribe
South Africa9907477► Subscribe
United Kingdom9814316► Subscribe
Argentina011759► Subscribe
Greece990100140► 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:

Cerilliant
Chubb
UBS
Colorcon
Moodys
Deloitte
Julphar
Cantor Fitzgerald
Healthtrust
Express Scripts

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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