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Last Updated: July 20, 2024

SILENOR Drug Patent Profile


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Which patents cover Silenor, and when can generic versions of Silenor launch?

Silenor is a drug marketed by Currax and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in four countries.

The generic ingredient in SILENOR is doxepin hydrochloride. There are seven drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Silenor

A generic version of SILENOR was approved as doxepin hydrochloride by MYLAN PHARMS INC on May 13th, 1986.

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Drug patent expirations by year for SILENOR
Drug Prices for SILENOR

See drug prices for SILENOR

Drug Sales Revenue Trends for SILENOR

See drug sales revenues for SILENOR

Recent Clinical Trials for SILENOR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of BalamandPhase 4
Pernix Theraputics LLCPhase 4
Currax PharmaceuticalsPhase 4

See all SILENOR clinical trials

Pharmacology for SILENOR
Paragraph IV (Patent) Challenges for SILENOR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SILENOR Tablets doxepin hydrochloride 3 mg and 6 mg 022036 2 2010-09-16

US Patents and Regulatory Information for SILENOR

SILENOR is protected by fifteen US patents.

Patents protecting SILENOR

Methods of using low-dose doxepin for the improvement of sleep
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Low-dose doxepin formulations and methods of making and using the same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Methods of improving the pharmacokinetics of doxepin
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Methods of using low-dose doxepin for the improvement of sleep
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Low-dose doxepin formulations and methods of making and using the same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Methods of improving the pharmacokinetics of doxepin
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Low-dose doxepin for treatment of sleep disorders in elderly patients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Methods of improving the pharmacokinetics of doxepin
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Methods of using low-dose doxepin for the improvement of sleep
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Methods of using low-dose doxepin for the improvement of sleep
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Methods of using low-dose doxepin for the improvement of sleep
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Low-dose doxepin formulations and methods of making and using the same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods of improving the pharmacokinetics of doxepin
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Methods of using low-dose doxepin for the improvement of sleep
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INSOMNIA

Low-dose doxepin formulations and methods of making and using the same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SILENOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ⤷  Sign Up ⤷  Sign Up
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ⤷  Sign Up ⤷  Sign Up
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SILENOR

See the table below for patents covering SILENOR around the world.

Country Patent Number Title Estimated Expiration
Canada 2687124 FORMULATIONS DE DOXEPINE A FAIBLE DOSE, INCLUANT DES FORMULATIONS BUCCALES, SUBLINGUALES ET A DISSOLUTION RAPIDE, ET LEURS UTILISATIONS POUR TRAITER L'INSOMNIE (LOW DOSE DOXEPIN FORMULATIONS, INCLUDING BUCCAL, SUBLINGUAL AND FASTMELT FORMULATIONS, AND USES OF THE SAME TO TREAT INSOMNIA) ⤷  Sign Up
Israel 139728 AQUEOUS SLURRY COMPOSITION CONTAINING MICROCRYSTALLINE CELLULOSE FOR PREPARING A PHARMACEUTICAL EXCIPIENT ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2008128115 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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