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Serving leading biopharmaceutical companies globally:

Teva
Farmers Insurance
Baxter
Cantor Fitzgerald
Johnson and Johnson
US Army
Fish and Richardson
Boehringer Ingelheim
Citi
Covington

Generated: December 11, 2017

DrugPatentWatch Database Preview

BRISDELLE Drug Profile

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When do Brisdelle patents expire, and when can generic versions of Brisdelle launch?

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-three 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. Four suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland LtdBRISDELLEparoxetine mesylateCAPSULE;ORAL204516-001Jun 28, 2013ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sebela Ireland LtdBRISDELLEparoxetine mesylateCAPSULE;ORAL204516-001Jun 28, 2013ABRXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Sebela Ireland LtdBRISDELLEparoxetine mesylateCAPSULE;ORAL204516-001Jun 28, 2013ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sebela Ireland LtdBRISDELLEparoxetine mesylateCAPSULE;ORAL204516-001Jun 28, 2013ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Sebela Ireland LtdBRISDELLEparoxetine mesylateCAPSULE;ORAL204516-001Jun 28, 2013ABRXYesYes► Subscribe► Subscribe► SubscribeYY► 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
European Patent Office1078925► Subscribe
Russian Federation2009107739► Subscribe
Japan5846717► Subscribe
Iceland7098► Subscribe
World Intellectual Property Organization (WIPO)9856787► Subscribe
China101505759► Subscribe
Japan5895009► Subscribe
Mexico2009001275► Subscribe
European Patent Office0994872► Subscribe
South Korea20150132888► 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:

Fuji
Queensland Health
QuintilesIMS
Colorcon
Chinese Patent Office
Novartis
US Department of Justice
McKinsey
Baxter
UBS

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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