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Last Updated: August 11, 2020

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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 thirteen 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-five suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

US ANDA 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

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Drug Sales Revenue Trends for SILENOR

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Recent Clinical Trials for SILENOR

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

SponsorPhase
University of BalamandPhase 4
Pernix Theraputics LLCPhase 4
Henry Ford HospitalPhase 4

See all SILENOR clinical trials

Pharmacology for SILENOR
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   Start Trial   Start Trial   Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010   Start Trial   Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
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