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Serving leading biopharmaceutical companies globally:

Argus Health
Healthtrust
Boehringer Ingelheim
QuintilesIMS
Cipla
Merck
Daiichi Sankyo
UBS
US Army
McKinsey

Generated: November 17, 2017

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Paroxetine mesylate - Generic Drug Details

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

Paroxetine mesylate
is the generic ingredient in three branded drugs marketed by Sebela Ireland Ltd, Actavis Labs Fl Inc, and Prinston Inc, and is included in four NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paroxetine mesylate has sixty-four patent family members in thirty-two countries.

There are thirty drug master file entries for paroxetine mesylate. Five suppliers are listed for this compound.

Pharmacology for paroxetine mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-004Jul 3, 2003RXYesYes► Subscribe► Subscribe ► Subscribe
Sebela Ireland Ltd
BRISDELLE
paroxetine mesylate
CAPSULE;ORAL204516-001Jun 28, 2013ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Sebela Ireland Ltd
BRISDELLE
paroxetine mesylate
CAPSULE;ORAL204516-001Jun 28, 2013ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-003Jul 3, 2003RXYesNo► Subscribe► Subscribe ► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-002Jul 3, 2003RXYesNo► Subscribe► Subscribe ► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-001Jul 3, 2003RXYesNo► Subscribe► SubscribeY ► Subscribe
Sebela Ireland Ltd
BRISDELLE
paroxetine mesylate
CAPSULE;ORAL204516-001Jun 28, 2013ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Sebela Ireland Ltd
BRISDELLE
paroxetine mesylate
CAPSULE;ORAL204516-001Jun 28, 2013ABRXYesYes► Subscribe► Subscribe ► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-003Jul 3, 2003RXYesNo► Subscribe► SubscribeY ► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-004Jul 3, 2003RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: paroxetine mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd
BRISDELLE
paroxetine mesylate
CAPSULE;ORAL204516-001Jun 28, 2013► Subscribe► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-002Jul 3, 2003► Subscribe► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-003Jul 3, 2003► Subscribe► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-001Jul 3, 2003► Subscribe► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-004Jul 3, 2003► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: paroxetine mesylate

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
8,859,576Method of treating thermoregulatory dysfunction with paroxetine► Subscribe
6,900,327 4-phenylpiperidine compounds► Subscribe
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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 mesylate

Country Document Number Estimated Expiration
Czech Republic9904295► Subscribe
Slovakia283394► Subscribe
Slovenia0994872► Subscribe
South Korea100543614► Subscribe
Japan2002503248► Subscribe
European Patent Office1078925► Subscribe
Brazil9714787► Subscribe
Hungary0003141► Subscribe
Norway20033766► Subscribe
SloveniaEP0994872► 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:

Cipla
Mallinckrodt
Citi
McKesson
Harvard Business School
Baxter
Farmers Insurance
UBS
QuintilesIMS
McKinsey

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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