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Last Updated: June 25, 2021

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SILENOR Drug 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 twelve 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

Paragraph IV (Patent) Challenges for SILENOR
Tradename Dosage Ingredient NDA Submissiondate
SILENOR TABLET;ORAL doxepin hydrochloride 022036 2010-09-16

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
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
>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   Get Started Free   Get Started Free
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010   Get Started Free   Get Started Free
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010   Get Started Free   Get Started Free
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010   Get Started Free   Get Started Free
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Moodys
McKesson
Medtronic
Colorcon

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