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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Johnson and Johnson
Cipla
Citi
Mallinckrodt
Moodys
Cerilliant
Argus Health
Deloitte
Fuji

Generated: September 24, 2017

DrugPatentWatch Database Preview

Pernix Therap Company Profile

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What is the competitive landscape for PERNIX THERAP, and what generic alternatives to PERNIX THERAP drugs are available?

PERNIX THERAP has three approved drugs.

There are seven US patents protecting PERNIX THERAP drugs.

There are fifteen patent family members on PERNIX THERAP drugs in four countries.

Summary for Applicant: Pernix Therap

Patents:7
Tradenames:2
Ingredients:2
NDAs:3
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► Subscribe ► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010ABRXYesYes► Subscribe► Subscribe ► Subscribe
Pernix Therap
CEDAX
ceftibuten dihydrate
FOR SUSPENSION;ORAL050686-001Dec 20, 1995DISCNYesNo► Subscribe► Subscribe► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010ABRXYesYes► Subscribe► Subscribe ► Subscribe
Pernix Therap
CEDAX
ceftibuten dihydrate
FOR SUSPENSION;ORAL050686-002Dec 20, 1995DISCNYesNo► 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
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Expired Patents for Pernix Therap

Paragraph IV activity for PERNIX THERAP drugs

Drugname Dosage Strength Tradename Submissiondate
doxepin hydrochloride
Tablets3 mg and 6 mg
SILENOR
9/16/2010

Non-Orange Book Patents for Pernix Therap

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 Pernix Therap Drugs

Country Document Number Estimated Expiration
Japan2016041757► Subscribe
Canada2721133► Subscribe
Japan2009537554► Subscribe
Canada2687118► Subscribe
World Intellectual Property Organization (WIPO)2008011150► Subscribe
World Intellectual Property Organization (WIPO)2007142810► Subscribe
World Intellectual Property Organization (WIPO)2007136845► Subscribe
European Patent Office2026792► Subscribe
Canada2687124► Subscribe
Canada2693992► 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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Supplementary Protection Certificates for Pernix Therap Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0003Belgium► SubscribePRODUCT NAME: CEFTIBUTEN.; NAT REG.: 304 S 144 F5 19941222; FIRST REG.: IT 0 27 84 9025 19920303
C0002Belgium► SubscribePRODUCT NAME: CEFTIBUTEN + SURDOSAGE DE 8% ; NAT REG.: 304 S 146 FO 19941222; FIRST REG.: IT 0 27 84 9052 19920303
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Express Scripts
McKesson
Cipla
Moodys
Julphar
QuintilesIMS
AstraZeneca
Fish and Richardson
Cerilliant
Covington

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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