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Details for Generic Name: doxepin hydrochloride

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Doxepin hydrochloride is the generic ingredient in four branded drugs marketed by Dava Pharms Inc, Mutual Pharm, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Watson Labs, Pfizer, Pharm Assoc, Silarx, Teva Pharms, Wockhardt, Delcor Asset Corp, Actavis Elizabeth, and Pernix Theraps Llc, and is included in fifty-eight NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-three patent family members in seventeen countries.

There are seven drug master file entries for doxepin hydrochloride. Six suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: doxepin hydrochloride

Drug Master File Entries: see list7
Suppliers / Packaging: see list17
Therapeutic Class:Antidepressants
Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: doxepin hydrochloride

Tentative approvals for DOXEPIN HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL3MG
<disabled><disabled>TABLET; ORAL6MG
<disabled><disabled>TABLET; ORAL3MG

Clinical Trials for: doxepin hydrochloride

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

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

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

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

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

Courtesy of
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
Mutual Pharm
doxepin hydrochloride
CAPSULE;ORAL071521-001Feb 18, 1988DISCNNo<disabled><disabled>
Purepac Pharm
doxepin hydrochloride
CAPSULE;ORAL072110-001Sep 8, 1988DISCNNo<disabled><disabled>
New River
doxepin hydrochloride
CAPSULE;ORAL016987-002Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Par Pharm
doxepin hydrochloride
CAPSULE;ORAL071437-001Nov 9, 1987DISCNNo<disabled><disabled>
Dava Pharms Inc
doxepin hydrochloride
CAPSULE;ORAL071674-001Jan 5, 1988DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: doxepin hydrochloride

Country Document Number Publication Date
JapanH10512862Dec 08, 1998
Norway963733Sep 06, 1996
Mexico9603745Jul 31, 1997
Portugal752848Aug 29, 2003
Canada2183881Aug 01, 2000
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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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