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NDA

DOXEPIN HYDROCHLORIDE | N016798 | PFIZER LABORATORIES DIV PFIZER INC

6 strengths0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma NCT06017895	N/A	Recruiting	Nanfang Hospital, Southern Medical University	178	2023-10-31 → 2026-08-31

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

Source: Drugs@FDA application documents.

Products (6)

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#001 — EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴