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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Cerilliant
Medtronic
US Department of Justice
Novartis
Argus Health
Julphar
Accenture
Merck
Harvard Business School

Generated: June 23, 2017

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PAROXETINE MESYLATE - Generic Drug Details

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

Paroxetine mesylate
is the generic ingredient in two branded drugs marketed by Sebela Ireland Ltd and is included in two 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-one patent family members in thirty-two countries.

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

Summary for Generic Name: PAROXETINE MESYLATE

Tradenames:2
Patents:5
Applicants:1
NDAs:2
Drug Master File Entries: see list30
Suppliers / Packagers: see list3
Clinical Trials: see list703
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:PAROXETINE MESYLATE at DailyMed

Pharmacology for Ingredient: 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
BRISDELLE
paroxetine mesylate
CAPSULE;ORAL204516-001Jun 28, 2013RXYesYes8,946,251► SubscribeYY ► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-003Jul 3, 2003RXYesNo7,598,271► SubscribeY ► Subscribe
Sebela Ireland Ltd
BRISDELLE
paroxetine mesylate
CAPSULE;ORAL204516-001Jun 28, 2013RXYesYes7,598,271► SubscribeY ► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-001Jul 3, 2003RXYesNo7,598,271► SubscribeY ► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-004Jul 3, 2003RXYesYes7,598,271► 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
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-001Jul 3, 20035,874,447► Subscribe
Sebela Ireland Ltd
BRISDELLE
paroxetine mesylate
CAPSULE;ORAL204516-001Jun 28, 20135,874,447► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-002Jul 3, 20035,874,447► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-003Jul 3, 20035,874,447► Subscribe
Sebela Ireland Ltd
PEXEVA
paroxetine mesylate
TABLET;ORAL021299-004Jul 3, 20035,874,447► 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
6,900,327 4-phenylpiperidine compounds► Subscribe
8,859,576Method of treating thermoregulatory dysfunction with paroxetine► 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
South Korea20150132888► Subscribe
Iceland7098► Subscribe
World Intellectual Property Organization (WIPO)9856787► Subscribe
Estonia9900570► Subscribe
European Patent Office1078925► 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:

Boehringer Ingelheim
Cipla
Citi
Johnson and Johnson
US Army
Julphar
Medtronic
McKinsey
Cerilliant
Farmers Insurance

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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