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Last Updated: March 19, 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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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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INSOMNIA

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

Methods of improving the pharmacokinetics of doxepin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INSOMNIA

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

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

Methods of improving the pharmacokinetics of doxepin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INSOMNIA

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

Methods of improving the pharmacokinetics of doxepin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INSOMNIA

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

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

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

Low-dose doxepin formulations and methods of making and using the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of improving the pharmacokinetics of doxepin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INSOMNIA

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

Low-dose doxepin formulations and methods of making and using the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
>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
Australia 4759896 ⤷  Try a Trial
Norway 963733 ⤷  Try a Trial
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 ⤷  Try a Trial
Japan H10500426 ⤷  Try a Trial
European Patent Office 1287823 Excipient pharmaceutique à compressibilité améliorée (Pharmaceutical excipient having improved compressibility) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2007136845 ⤷  Try a Trial
Japan 2018044006 睡眠改善のための低用量ドキセピンの使用法 (METHODS OF USING LOW DOSE DOXEPIN FOR SLEEP IMPROVEMENT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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