Doxepin Hydrochloride

Manages moderate pruritus. Sold as Sinequan, Doxepin Hydrochloride, Zonalon, Silenor. Every FDA application for this active ingredient: 5 branded and 82 generic.

As of Nov 15, 2026, FDA lists 87 applications for Doxepin Hydrochloride (sold as Sinequan, Doxepin Hydrochloride, Zonalon and others), first approved Sep 23, 1969, with 1 new use approved and 0 published complete response letters.

First approved: Sep 23, 1969
Applications: 87
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $68.9M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Doxepin HCl	Part D	$68.5M	+4%	311,189
Silenor	Part D	$390K	-23%	123
Zonalon	Part D	$0K	-100%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

DOXEPIN 10 MG CAPSULE: $0.080 per unitGeneric · -1% in a year
DOXEPIN 10 MG/ML ORAL CONC: $0.888 per MLGeneric · +92% in a year
DOXEPIN 100 MG CAPSULE: $0.302 per unitGeneric · +30% in a year
DOXEPIN 150 MG CAPSULE: $0.530 per unitGeneric · +3% in a year
DOXEPIN 25 MG CAPSULE: $0.148 per unitGeneric · +19% in a year
DOXEPIN 5% CREAM: $7.85 per GMGeneric · -3% in a year
DOXEPIN 50 MG CAPSULE: $0.164 per unitGeneric · +14% in a year
DOXEPIN 75 MG CAPSULE: $0.224 per unitGeneric · -2% in a year
DOXEPIN HCL 3 MG TABLET: $1.36 per unitGeneric · -35% in a year
DOXEPIN HCL 6 MG TABLET: $1.41 per unitGeneric · -34% in a year

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Doxepin Alone or Combined With Ramelteon Versus Placebo for Improving Sleep Quality After Primary Total Knee ArthroplastySleep Quality Post-TKA, Postoperative Knee Function · University of Washington	Phase 4	Not yet recruiting	May 20, 2026
A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for InsomniaInsomnia, Insomnia Disorder · University of Pennsylvania	Phase 4	Recruiting	Apr 21, 2026
Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal CarcinomaSwallowing-induced Pain · Nanfang Hospital, Southern Medical University	Not applicable	Recruiting	Aug 30, 2023
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain PatientsChronic Insomnia, Chronic Pain · Salem Anaesthesia Pain Clinic	—	Recruiting	Nov 16, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 23, 1969	SinequanNDA 16798 · New molecular entity	Pfizer	35	Discontinued
Jan 31, 1972	Doxepin HydrochlorideNDA 16987 · New formulation or manufacturer	New River	26	Discontinued
Mar 11, 1974	SinequanNDA 17516 · New dosage form	Pfizer	16	Discontinued
May 13, 1986	Doxepin HydrochlorideANDA 70790	Mylan	9	Marketed
May 13, 1986	Doxepin HydrochlorideANDA 70792	Mylan	9	Marketed
May 13, 1986	Doxepin HydrochlorideANDA 70791	Mylan Pharms Inc	17	Marketed
May 13, 1986	Doxepin HydrochlorideANDA 70793	Mylan	11	Marketed
May 15, 1986	Doxepin HydrochlorideANDA 70825	Sandoz	5	Discontinued
May 15, 1986	Doxepin HydrochlorideANDA 70827	Sandoz	7	Discontinued
May 15, 1986	Doxepin HydrochlorideANDA 70828	Sandoz	7	Discontinued
Mar 2, 1987	Doxepin HydrochlorideANDA 71487	Sandoz	8	Discontinued
Mar 2, 1987	Doxepin HydrochlorideANDA 71562	Sandoz	8	Discontinued
Apr 30, 1987	Doxepin HydrochlorideANDA 71238	Watson Labs	18	Discontinued
Apr 30, 1987	Doxepin HydrochlorideANDA 71485	Watson Labs	18	Discontinued
Apr 30, 1987	Doxepin HydrochlorideANDA 71326	Watson Labs	18	Discontinued
Apr 30, 1987	Doxepin HydrochlorideANDA 71486	Watson Labs	18	Discontinued
Apr 30, 1987	Doxepin HydrochlorideANDA 71239	Watson Labs	18	Discontinued
Nov 9, 1987	Doxepin HydrochlorideANDA 71422	Ph Health	22	Discontinued
Nov 9, 1987	Doxepin HydrochlorideANDA 71609	Teva Pharms	23	Discontinued
Nov 9, 1987	Doxepin HydrochlorideANDA 71437	Par Pharm	25	Marketed
Feb 18, 1988	Doxepin HydrochlorideANDA 71502	Sun Pharm Industries	9	Discontinued
Feb 18, 1988	Doxepin HydrochlorideANDA 71654	Sun Pharm Industries	9	Discontinued
Feb 18, 1988	Doxepin HydrochlorideANDA 71521	Sun Pharm Industries	9	Discontinued
Feb 18, 1988	Doxepin HydrochlorideANDA 71653	Sun Pharm Industries	9	Discontinued
Jul 20, 1988	Doxepin HydrochlorideANDA 71918	Pharmobedient Cnsltg	10	Discontinued
Dec 28, 1990	Doxepin HydrochlorideANDA 73054	Purepac Pharm	1	Discontinued
Dec 28, 1990	Doxepin HydrochlorideANDA 73055	Purepac Pharm	1	Discontinued
Mar 29, 1991	Doxepin HydrochlorideANDA 72985	Watson Labs	13	Discontinued
Mar 29, 1991	Doxepin HydrochlorideANDA 72986	Watson Labs	13	Discontinued
Mar 29, 1991	Doxepin HydrochlorideANDA 72987	Watson Labs Teva	13	Discontinued
Apr 1, 1994	ZonalonNDA 20126 · New dosage form	Mylan	5	Marketed
Dec 29, 1998	Doxepin HydrochlorideANDA 74721	Lannett Co Inc	7	Marketed
Jan 15, 2004	Doxepin HydrochlorideANDA 75924	Pharm Assoc	1	Discontinued
Mar 17, 2010	SilenorNDA 22036 · New dosage form	Currax	4	Marketed
Jul 26, 2013	Doxepin HydrochlorideANDA 201951	Actavis Elizabeth	2	Marketed
Jan 20, 2016	Doxepin HydrochlorideANDA 202337	Rk Pharma	1	Marketed
Jun 28, 2017	Doxepin HydrochlorideANDA 207482	Amneal Pharms Co	1	Marketed
Mar 27, 2019	Doxepin HydrochlorideANDA 211603	Aurobindo Pharma Ltd	0	Marketed
Sep 13, 2019	Doxepin HydrochlorideANDA 212624	Ajanta Pharma Ltd	1	Marketed
Jul 1, 2020	Doxepin HydrochlorideANDA 213063	Taro	0	Discontinued
Jul 24, 2020	Doxepin HydrochlorideANDA 202510	Strides Pharma Intl	2	Marketed
Jul 24, 2020	Doxepin HydrochlorideANDA 212997	Lannett Co Inc	0	Discontinued
Jul 28, 2020	Doxepin HydrochlorideANDA 213474	Aiping Pharm Inc	0	Marketed
Sep 4, 2020	Doxepin HydrochlorideANDA 210268	Chartwell Rx	0	Marketed
Oct 16, 2020	Doxepin HydrochlorideANDA 210675	Epic Pharma LLC	3	Marketed
Mar 1, 2021	Doxepin HydrochlorideANDA 211618	Velzen Pharma Pvt	0	Marketed
Mar 9, 2021	Doxepin HydrochlorideANDA 211619	Leading	1	Marketed
Apr 1, 2021	Doxepin HydrochlorideANDA 214908	Appco	0	Marketed
Apr 21, 2021	Doxepin HydrochlorideANDA 215076	Alembic	1	Marketed
Feb 9, 2022	Doxepin HydrochlorideANDA 215710	Mankind Pharma	0	Marketed
Mar 14, 2022	Doxepin HydrochlorideANDA 215483	Jubilant Cadista	0	Marketed
Apr 19, 2022	Doxepin HydrochlorideANDA 213796	Adaptis	1	Discontinued
Jun 24, 2022	Doxepin HydrochlorideANDA 215113	Msn	0	Marketed
Feb 17, 2023	Doxepin HydrochlorideANDA 215408	Teva Pharms	0	Marketed
Mar 21, 2023	Doxepin HydrochlorideANDA 210140	Zydus Lifesciences	0	Marketed
Mar 23, 2023	Doxepin HydrochlorideANDA 210700	Zydus Lifesciences	0	Marketed
Apr 3, 2023	Doxepin HydrochlorideANDA 214823	Msn	0	Marketed
Jun 27, 2023	Doxepin HydrochlorideANDA 217688	Micro Labs	0	Discontinued
Aug 16, 2023	Doxepin HydrochlorideANDA 202761	Zydus Lifesciences	0	Marketed
Aug 16, 2023	Doxepin HydrochlorideANDA 212357	Amneal	0	Marketed
Aug 21, 2023	Doxepin HydrochlorideANDA 217975	Unique	0	Marketed
Jul 1, 2024	Doxepin HydrochlorideANDA 218564	Ajanta Pharma Ltd	0	Marketed
Jul 25, 2024	Doxepin HydrochlorideANDA 216041	Aurobindo Pharma Ltd	0	Marketed
Aug 6, 2025	Doxepin HydrochlorideANDA 219058	Taro	0	Marketed
Apr 28, 2026	Doxepin HydrochlorideANDA 213919	Sun Pharma Canada	0	Marketed
—	Doxepin HydrochlorideANDA 71685	Dava Pharms Inc	0	Discontinued
—	Doxepin HydrochlorideANDA 71686	Dava Pharms Inc	0	Discontinued
—	Doxepin HydrochlorideANDA 70931	Quantum Pharmics	0	Discontinued
—	Doxepin HydrochlorideANDA 70932	Quantum Pharmics	0	Discontinued
—	Doxepin HydrochlorideANDA 70952	Watson Labs	0	Discontinued
—	Doxepin HydrochlorideANDA 70953	Watson Labs	0	Discontinued
—	Doxepin HydrochlorideANDA 70954	Watson Labs	0	Discontinued
—	Doxepin HydrochlorideANDA 70955	Watson Labs	0	Discontinued
—	Doxepin HydrochlorideANDA 70972	Quantum Pharmics	0	Discontinued
—	Doxepin HydrochlorideANDA 70973	Quantum Pharmics	0	Discontinued
—	Doxepin HydrochlorideANDA 71673	Dava Pharms Inc	0	Discontinued
—	Doxepin HydrochlorideANDA 71674	Dava Pharms Inc	0	Discontinued
—	Doxepin HydrochlorideANDA 71675	Dava Pharms Inc	0	Discontinued
—	Doxepin HydrochlorideANDA 71676	Dava Pharms Inc	0	Discontinued
—	Doxepin HydrochlorideANDA 71763	Watson Labs	0	Discontinued
—	Doxepin HydrochlorideANDA 71764	Watson Labs	0	Discontinued
—	Doxepin HydrochlorideANDA 72109	Purepac Pharm	0	Discontinued
—	Doxepin HydrochlorideANDA 72110	Purepac Pharm	0	Discontinued
—	Doxepin HydrochlorideANDA 72387	Purepac Pharm	0	Discontinued
—	Doxepin HydrochlorideANDA 72375	Quantum Pharmics	0	Discontinued
—	Doxepin HydrochlorideANDA 72376	Quantum Pharmics	0	Discontinued
—	Doxepin HydrochlorideANDA 72386	Purepac Pharm	0	Discontinued

Show all 87

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA