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Profile for Tradename: SILENOR

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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 nine patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in SILENOR is doxepin hydrochloride. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for Tradename: SILENOR

Patents:9
Applicants:1
NDAs:1
Suppliers: see list1

Pharmacology for Tradename: SILENOR

Clinical Trials for: SILENOR

Glossary
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, 2010RXNo6,217,909<disabled>Y<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010RXYes5,585,115<disabled>Y<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010RXNo6,211,229<disabled><disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010RXNo5,725,884<disabled>Y<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010RXYes7,915,307<disabled><disabled>
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Paragraph IV activity for: SILENOR

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

Premature patent expiration for: SILENOR

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
5,725,884
SILENOR
March 10, 2006
5,948,438
SILENOR
September 07, 2011
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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