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SILENOR Drug Profile

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Silenor is a drug marketed by Pernix Theraps Llc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has twelve 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-seven suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for Tradename: SILENOR

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: SILENOR

Clinical Trials for: SILENOR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010RXNo6,211,229<disabled> <disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010RXYes9,107,898<disabled> <disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010RXNo9,107,898<disabled> <disabled>
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Expired Patents for Tradename: SILENOR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 20105,725,884<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 20105,502,047<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 20105,948,438<disabled>
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Paragraph IV activity for: SILENOR

Drugname Dosage Strength RLD Submissiondate
doxepin hydrochlorideTablets3 mg and 6 mgSilenor9/16/2010

International Patent Family for Tradename: SILENOR

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2007142811<disabled in preview>
European Patent Office2026792<disabled in preview>
Japan2016041757<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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