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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.

This drug has fifty-three patent family members in seventeen 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 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 / 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

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

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

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, 2010RXYes5,948,438<disabled>Y<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010RXNo6,103,219<disabled>Y<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 2010RXNo5,866,166<disabled>Y<disabled>
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 2010RXYes8,513,299<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

Non-Orange Book Patents for Tradename: SILENOR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,106,865 Pharmaceutical excipient having improved compressibility<disabled in preview>
6,936,277 Pharmaceutical excipient having improved compressibility<disabled in preview>
5,725,883 Pharmaceutical excipient having improved compressibility<disabled in preview>
6,471,994 Pharmaceutical excipient having improved compressibility<disabled in preview>
5,858,412 Sustained release formulations utilizing pharmaceutical excipient having improved compressibility with modified microcrystalline<disabled in preview>
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International Patent Family for Tradename: SILENOR

Country Document Number Publication Date
Germany69638054Nov 26, 2009
World Intellectual Property Organization (WIPO)2007142811Dec 13, 2007
Portugal752848Aug 29, 2003
Taiwan505529Oct 11, 2002
Canada2687124Dec 13, 2007
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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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