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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. Four 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

Suppliers: 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
doxepin hydrochloride
TABLET;ORAL022036Mar 17, 2010RXYes5,585,115<disabled>Y<disabled>
Pernix Theraps Llc
doxepin hydrochloride
TABLET;ORAL022036Mar 17, 2010RXNo5,725,884<disabled>Y<disabled>
Pernix Theraps Llc
doxepin hydrochloride
TABLET;ORAL022036Mar 17, 2010RXNo6,211,229<disabled><disabled>
Pernix Theraps Llc
doxepin hydrochloride
TABLET;ORAL022036Mar 17, 2010RXNo6,217,909<disabled>Y<disabled>
Pernix Theraps Llc
doxepin hydrochloride
TABLET;ORAL022036Mar 17, 2010RXYes6,103,219<disabled>Y<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:5,725,884 Tradename:
Expiration Date:March 10, 2006
Patent Number:5,948,438 Tradename:
Expiration Date:September 07, 2011
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ISSN: 2162-2639

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

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