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Generated: October 21, 2017

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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 twenty-four 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

US Patents:5
Tradenames:4
Applicants:17
NDAs:22
Drug Master File Entries: see list30
Suppliers / Packagers: see list55
Bulk Api Vendors: see list107
Clinical Trials: see list2,470
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
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
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-004Oct 9, 1998DISCNYesNo► Subscribe► SubscribeY► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-004Oct 9, 1998DISCNYesNo► Subscribe► SubscribeY► Subscribe
Apotex Inc
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
SUSPENSION;ORAL077395-001Dec 5, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL078902-003Mar 13, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Kremers Urban Pharms
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL204744-002Jun 10, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-003Oct 9, 1998DISCNYesNo► Subscribe► SubscribeY► Subscribe
Mylan
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL078902-002Mar 13, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL077584-004Mar 7, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Oxford Pharms
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL076968-002Jun 21, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Jubilant Generics
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL205528-003Nov 27, 2015ABRXNoNo► 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 Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-001Oct 9, 1998► Subscribe► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-004Oct 9, 1998► Subscribe► Subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999► Subscribe► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-003Oct 9, 1998► Subscribe► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-004Oct 9, 1998► Subscribe► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-003Dec 29, 1992► Subscribe► Subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999► Subscribe► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
SUSPENSION;ORAL020710-001Jun 25, 1997► Subscribe► Subscribe
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000► Subscribe► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-002Oct 9, 1998► Subscribe► Subscribe
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International Patent Family for Ingredient: paroxetine hydrochloride

Country Document Number Estimated Expiration
Switzerland690024► Subscribe
Germany29921300► Subscribe
France2802098► Subscribe
Eurasian Patent Organization003508► Subscribe
Germany69900007► Subscribe
Denmark0839039► Subscribe
Japan2006265258► Subscribe
FinlandU990494► Subscribe
Finland112077► Subscribe
United Kingdom9700690► 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:

Farmers Insurance
Dow
Teva
Baxter
Colorcon
US Army
Mallinckrodt
Fuji
AstraZeneca
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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