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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
AstraZeneca
Healthtrust
Cipla
Dow
Merck
Fish and Richardson
Deloitte
McKinsey
Moodys

Generated: October 17, 2017

DrugPatentWatch Database Preview

BRISDELLE Drug Profile

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Which patents cover Brisdelle, and what generic Brisdelle alternatives are available?

Brisdelle is a drug marketed by Sebela Ireland Ltd and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-four patent family members in thirty-two countries.

The generic ingredient in BRISDELLE is paroxetine mesylate. There are thirty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.

Summary for Tradename: BRISDELLE

US Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list41
Clinical Trials: see list4
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BRISDELLE at DailyMed

Pharmacology for Tradename: BRISDELLE

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, 2013ABRXYesYes► Subscribe► SubscribeYY ► 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
BRISDELLE
paroxetine mesylate
CAPSULE;ORAL204516-001Jun 28, 2013ABRXYesYes► Subscribe► Subscribe ► Subscribe
Sebela Ireland Ltd
BRISDELLE
paroxetine mesylate
CAPSULE;ORAL204516-001Jun 28, 2013ABRXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: BRISDELLE

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
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Paragraph IV (Patent) Challenges for BRISDELLE

Drugname Dosage Strength RLD Submissiondate
paroxetineCapsules7.5 mgBrisdelle4/7/2014

Non-Orange Book Patents for Tradename: BRISDELLE

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 Tradename: BRISDELLE

Country Document Number Estimated Expiration
Singapore176452► Subscribe
Norway995455► Subscribe
Slovakia161999► Subscribe
Iceland1927► Subscribe
Brazil9714787► Subscribe
Canada2293247► Subscribe
Japan2014077023► Subscribe
Slovakia283394► Subscribe
Canada2659577► Subscribe
BrazilPI0715087► 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:

Accenture
Baxter
Express Scripts
AstraZeneca
Federal Trade Commission
McKesson
US Army
Argus Health
Chinese Patent Office
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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