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Serving 500+ biopharmaceutical companies globally:

US Army
Accenture
Queensland Health
Fish and Richardson
Citi
Deloitte
McKinsey
Colorcon
Moodys
Farmers Insurance

Generated: September 22, 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 Mylan, Aurobindo Pharma, Apotex Technologies, Mylan Pharms Inc, Teva, Roxane, Jubilant Generics, Lupin Ltd, Kremers Urban Pharms, Prinston Inc, Apotex, Upsher-smith Labs, Oxford Pharms, Teva Pharms, Zydus Pharms Usa, Sun Pharm Inds Inc, and Apotex Inc, 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 fourteen patent family members in fifty-one countries.

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

Summary for Generic Name: paroxetine hydrochloride

Tradenames:4
Patents:5
Applicants:17
NDAs:22
Drug Master File Entries: see list30
Suppliers / Packagers: see list55
Bulk Api Vendors: see list107
Clinical Trials: see list2,459
Patent Applications: see list1,133
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:paroxetine hydrochloride at DailyMed

Pharmacology for Ingredient: paroxetine hydrochloride

Tentative approvals for PAROXETINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► SubscribeEQ 10MG BASETABLET;ORAL
► Subscribe► SubscribeEQ 40MG BASETABLET;ORAL
► Subscribe► 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
Prinston Inc
PAROXETINE
paroxetine hydrochloride
TABLET;ORAL203854-004Oct 31, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Jubilant Generics
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL205528-004Nov 27, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL078406-002Jul 25, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL204134-001Jan 20, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Prinston Inc
PAROXETINE
paroxetine hydrochloride
TABLET;ORAL203854-001Oct 31, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL077082-003Jun 29, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL204134-003Jan 20, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Jubilant Generics
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL205528-001Nov 27, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Roxane
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL078026-002Jun 29, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-001Dec 29, 1992ABRXYesNo► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: paroxetine hydrochloride

International Patent Family for Ingredient: paroxetine hydrochloride

Country Document Number Estimated Expiration
Hungary0103712► Subscribe
Portugal1089996► Subscribe
Slovakia5398► Subscribe
Taiwan464513► Subscribe
Belgium1013166► Subscribe
Japan2002519422► Subscribe
Germany60000003► Subscribe
Eurasian Patent Organization199800140► Subscribe
Argentina003463► Subscribe
African Regional IP Organization (ARIPO)1052► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Covington
US Army
Teva
AstraZeneca
Baxter
Novartis
Citi
Johnson and Johnson
Harvard Business School
Fish and Richardson

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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