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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 four patents protecting this drug and one Paragraph IV challenge.

This drug has eleven patent family members in four countries.

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 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 list8

Pharmacology for Tradename: SILENOR

Clinical Trials for: SILENOR

Assess the Effect of a Single Dose of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognitive Performance in Healthy Volunteers
Status: Not yet recruiting Condition: Healthy

Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia
Status: Completed Condition: Sleep Initiation and Maintenance Disorders

Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy
Status: Active, not recruiting Condition: Lymphoma; Malignant Mesothelioma; Malignant Pericardial Effusion; Malignant Pleural Effusion; Non-small Cell Lung Cancer; Small Cell Lung Cancer; Soft Tissue Sarcoma; Thymoma and Thymic Carcinoma

Topical Doxepin for Radiation-induced Dermatitis
Status: Recruiting Condition: Breast Cancer

Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
Status: Recruiting Condition: Acute Oral Mucositis Pain

Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy
Status: Active, not recruiting Condition: Head and Neck Cancer; Mucositis; Oral Complications of Radiation Therapy; Pain

Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome
Status: Completed Condition: Irritable Bowel Syndrome

The Treatment of Insomnia in Patients With HIV Disease
Status: Completed Condition: HIV Infections; Insomnia

Treatments for Insomnia in Patients With Parkinson's Disease
Status: Completed Condition: Parkinson's Disease; Insomnia

Pharmacovigilance in Gerontopsychiatric Patients
Status: Recruiting Condition: Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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, 2010RXYes8,513,299<disabled> <disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010RXNo9,107,898<disabled>Y <disabled>
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Expired Patents for Tradename: SILENOR

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 20105,866,166<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 20105,502,047<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 20106,103,219<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 Publication Date
Canada2693992Jan 24, 2008
Japan2013237694Nov 28, 2013
World Intellectual Property Organization (WIPO)2007142810Dec 13, 2007
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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