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NDA

DOXEPIN HYDROCHLORIDE | N017516 | PFIZER LABORATORIES DIV PFIZER INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hibrow Healthcare LLC FDA-2019-P-4424 · 4 docket documents Hibrow Healthcare LLC submitted this petition on September 23, 2019, requesting that the FDA determine that Doxepin Hydrochloride Oral Concentrate 10 mg base/mL approved under ANDA 071609 by Teva Pharmaceuticals USA was not voluntarily withdrawn for safety and efficacy reasons, noting that the refer	505(q)	2019-09-23	Granted	Hibrow Healthcare LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

11 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy NCT01156142	Phase 3	Completed	Alliance for Clinical Trials in Oncology	155	2010-12 → 2015-03-02
Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia NCT00755495	Phase 2	Completed	Takeda	472	2006-07 → 2007-03
The Treatment of Insomnia in Patients With HIV Disease NCT00465972	Phase 4	Completed	Duke University	44	2007-03 → 2010-08
Treatments for Insomnia in Patients With Parkinson's Disease NCT01489982	Early Phase 1	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre	20	2011-01 → 2012-12
Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers NCT02353299	Phase 4	Completed	Currax Pharmaceuticals	52	2015-01 → 2016-03
Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy NCT02229539	Phase 3	Completed	Alliance for Clinical Trials in Oncology	275	2014-11-18 → 2019-03-15
Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome NCT01268709	Phase 2	Completed	Qom University of Medical Sciences	—	—
Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus NCT03758079	Phase 4	Completed	University of Balamand	14	2018-06-01 → 2018-10-08
Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy NCT02062632	Phase 2	Terminated	Mayo Clinic	5	2014-04-14 → 2017-11-06
Pharmacovigilance in Gerontopsychiatric Patients NCT02374567	Phase 3	Terminated	Hannover Medical School	407	2015-01 → 2017-06-28

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain4 active DMFs2 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

OLON SPADOXEPIN HYDROCHLORIDE

DMF 50251983

MSN LIFE SCIENCES PRIVATE LTDDOXEPIN HYDROCHLORIDE USP

DMF 335592019

R L FINE CHEM PVT LTDDOXEPIN HYDROCHLORIDE

DMF 344382020

RAKS PHARMA PVT LTDDOXEPIN HYDROCHLORIDE USP

DMF 350172020

BOEHRINGER MANNHEIM GMBHInactiveDOXEPIN

DMF 24101975

GANES CHEMICALS INC PENNSVILLE DIVInactiveDOXEPIN HYDROCHLORIDE

DMF 68561987

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jul 8, 2025	SUPPL -26	View Letter (PDF)
Jul 15, 2014	SUPPL -25	View Letter (PDF)
Aug 7, 2007	SUPPL -23	View Letter (PDF)
Feb 23, 2005	SUPPL -22	View Letter (PDF)
Oct 9, 2003	SUPPL -20	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CONCENTRATE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.