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Last Updated: March 28, 2024

SILENOR Drug Patent Profile


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Which patents cover Silenor, and what generic alternatives are available?

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
>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 ⤷  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 022036-001 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 022036-001 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
Hungary 9602361 ⤷  Try a Trial
Germany 69638054 ⤷  Try a Trial
Canada 2693992 METHODES DESTINEES A AMELIORER LA PHARMACOCINETIQUE DE LA DOXEPINE (METHODS OF IMPROVING THE PHARMACOKINETICS OF DOXEPIN) ⤷  Try a Trial
Austria 239450 ⤷  Try a Trial
Australia 5830399 ⤷  Try a Trial
Canada 2183882 EXCIPIENT PHARMACEUTIQUE A COMPRESSIBILITE AMELIOREE (PHARMACEUTICAL EXCIPIENT HAVING IMPROVED COMPRESSIBILITY) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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