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Serving leading biopharmaceutical companies globally:

Express Scripts
Julphar
QuintilesIMS
Merck
Chubb
Citi
Mallinckrodt
Deloitte
Queensland Health
McKesson

Generated: February 22, 2018

DrugPatentWatch Database Preview

SILENOR Drug Profile

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When do Silenor patents expire, 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 eight 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.
Summary for SILENOR
Drug patent expirations by year for SILENOR
Pharmacology for SILENOR
Medical Subject Heading (MeSH) Categories for SILENOR

US Patents and Regulatory Information for SILENOR

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;ORAL 022036-001 Mar 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for SILENOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for SILENOR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 3 mg and 6 mg ➤ Subscribe 9/16/2010

Non-Orange Book US Patents for 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
9,463,181 Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders ➤ Try a Free Trial
9,498,462 Doxepin trans isomers and isomeric mixtures and methods of using the same to treat sleep disorders ➤ Try a Free Trial
9,801,847 Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for SILENOR

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

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Queensland Health
McKesson
Mallinckrodt
US Army
Johnson and Johnson
Chinese Patent Office
UBS
Fuji

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