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Last Updated: October 1, 2022

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. Thirty-six 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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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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Low-dose doxepin formulations and methods of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Methods of improving the pharmacokinetics of doxepin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Methods of using low-dose doxepin for the improvement of sleep
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Low-dose doxepin formulations and methods of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Methods of improving the pharmacokinetics of doxepin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Low-dose doxepin for treatment of sleep disorders in elderly patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Methods of improving the pharmacokinetics of doxepin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Methods of using low-dose doxepin for the improvement of sleep
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Methods of using low-dose doxepin for the improvement of sleep
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Methods of using low-dose doxepin for the improvement of sleep
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Low-dose doxepin formulations and methods of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of improving the pharmacokinetics of doxepin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Methods of using low-dose doxepin for the improvement of sleep
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INSOMNIA

Low-dose doxepin formulations and methods of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 022036-002 Mar 17, 2010 See Plans and Pricing See Plans and Pricing
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 See Plans and Pricing See Plans and Pricing
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 See Plans and Pricing See Plans and Pricing
>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
Norway 320533 See Plans and Pricing
Israel 116674 MICROCRYSTALLINE CELLULOSE-BASED EXCIPIENT HAVING IMPROVED COMPRESSIBILITY, PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME AND METHODS FOR THE PREPARATION OF SAID EXCIPIENT AND OF SOLID DOSAGE FORM THEREOF See Plans and Pricing
Portugal 752848 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Moodys
McKesson
Medtronic
Colorcon

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 verification 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.