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Paroxetine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for paroxetine hydrochloride?

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 six 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 thirteen patent family members in fifty-one countries.

There are thirty drug master file entries for paroxetine hydrochloride. Fifty-four suppliers are listed for this compound.

Summary for Generic Name: paroxetine hydrochloride

Tradenames:4
Patents:6
Applicants:17
NDAs:22
Drug Master File Entries: see list30
Suppliers / Packagers: see list54
Bulk Api Vendors: see list107
Clinical Trials: see list1,043
Patent Applications: see list5,735
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:paroxetine hydrochloride at DailyMed

Pharmacology for Ingredient: paroxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-002Oct 9, 1998DISCNYesNo6,121,291*PED► SubscribeY► Subscribe
Jubilant Generics
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL205528-002Nov 27, 2015RXNoNo► Subscribe► Subscribe
Mylan
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL077873-002Jun 29, 2007RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL075716-004Mar 8, 2004RXNoNo► Subscribe► Subscribe
Sun Pharm Inds Inc
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL078194-004Jun 29, 2007RXNoNo► 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
TABLET;ORAL020031-002Dec 29, 19925,789,449*PED► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-002Oct 9, 19985,900,423*PED► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-003Dec 29, 19925,789,449*PED► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-004Dec 29, 19926,133,289*PED► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-005Dec 29, 19926,113,944*PED► Subscribe
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International Patent Family for Ingredient: paroxetine hydrochloride

Country Document Number Estimated Expiration
Israel140385► Subscribe
IrelandS20000894► Subscribe
Italy1312540► Subscribe
United Kingdom9928693► Subscribe
Israel122940► 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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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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