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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Healthtrust
Express Scripts
Cerilliant
US Department of Justice
Daiichi Sankyo
AstraZeneca
Dow
Covington
Accenture

Generated: November 20, 2017

DrugPatentWatch Database Preview

SILENOR Drug Profile

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What is the patent landscape for Silenor, and when can generic versions of Silenor launch?

Silenor is a drug marketed by Pernix Theraps Llc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has fifteen patent family members in four countries.

The generic ingredient in SILENOR is doxepin hydrochloride. There are seven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010ABRXYesNo► Subscribe► Subscribe ► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010ABRXYesNo► Subscribe► Subscribe ► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010ABRXYesYes► Subscribe► Subscribe ► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010ABRXYesYes► Subscribe► Subscribe ► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010ABRXYesNo► Subscribe► Subscribe ► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010ABRXYesNo► Subscribe► Subscribe ► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010ABRXYesNo► Subscribe► Subscribe ► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010ABRXYesNo► Subscribe► Subscribe ► Subscribe
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Paragraph IV (Patent) Challenges for SILENOR

Drugname Dosage Strength RLD Submissiondate
doxepin hydrochlorideTablets3 mg and 6 mgSilenor9/16/2010

Non-Orange Book Patents for Tradename: SILENOR

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
9,463,181Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders► Subscribe
9,498,462Doxepin trans isomers and isomeric mixtures and methods of using the same to treat sleep disorders► 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: SILENOR

Country Document Number Estimated Expiration
Canada2687124► Subscribe
World Intellectual Property Organization (WIPO)2007142811► Subscribe
World Intellectual Property Organization (WIPO)2008011150► Subscribe
Japan2009537554► Subscribe
World Intellectual Property Organization (WIPO)2007142810► Subscribe
European Patent Office2026792► Subscribe
Japan2013237694► Subscribe
European Patent Office2148659► Subscribe
World Intellectual Property Organization (WIPO)2007136845► Subscribe
Canada2721133► 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 leading biopharmaceutical companies globally:

Fuji
Chinese Patent Office
Dow
Deloitte
US Department of Justice
Julphar
Mallinckrodt
Moodys
Farmers Insurance
Citi

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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