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Doxepin hydrochloride - Generic Drug Details

What are the generic drug sources for doxepin hydrochloride and what is the scope of doxepin hydrochloride patent protection?

Doxepin hydrochloride is the generic ingredient in four branded drugs marketed by Amneal Pharms Co, Dava Pharms Inc, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Watson Labs Teva, Pfizer, Lannett Co Inc, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Actavis Elizabeth, and Pernix Theraps Llc, and is included in sixty NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doxepin hydrochloride has fifteen patent family members in four countries.

There are seven drug master file entries for doxepin hydrochloride. Twenty-nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for doxepin hydrochloride

International Patents:	15
US Patents:	9
Tradenames:	4
Applicants:	18
NDAs:	60
Drug Master File Entries:	7
Suppliers / Packagers:	29
Bulk Api Vendors:	56
Clinical Trials:	15
Patent Applications:	1,041
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for doxepin hydrochloride
DailyMed Link:	doxepin hydrochloride at DailyMed

Pharmacology for doxepin hydrochloride

Drug Class	Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for doxepin hydrochloride

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Synonyms for doxepin hydrochloride

(3-(6H-dibenzo[c,f]oxepin-11-ylidene)propyl)dimethylamine, chloride
(3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethyl-1-propanamine hydrochloride
(3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethyl-propan-1-amine hydrochloride
(3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine
(3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine hydrochloride
(3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine;hydrochloride
(3e)-3-(Dibenzo[b,E]oxepin-11(6h)-Ylidene)-N,N-Dimethylpropan-1-Amine
(3E)-3-dibenzo[b,e]oxepin-11(6H)-ylidene-N,N-dimethylpropan-1-amine
(3Z)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-di(methyl)propan-1-amine
(3Z)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine
(E)-3-(Dibenzo[b,e]oxepin-11(6H)-ylidene)-N,N-dimethylpropan-1-amine
(e)-doxepin
(e)-doxepin hydrochloride
[11C]-doxepin
[11C]doxepin
1-Propanamine, 3-dibenz(b,e)oxepin-11-(6H)-ylidene-N,N-dimethyl-dimethyl-, hydrochloride, (E)-
1-Propanamine, 3-dibenz(b,e)oxepin-11(6H)-ylidene-N,N-dimethyl-
1-Propanamine, 3-dibenz(b,e)oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride
11-(3-(Dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin hydrochloride
11-(3-(Dimethylamino)propylidene)-6H-dibenz(b,e)oxepine
11-(3-Dimethylamino-propyliden)-6,11-dihydro-dibenz(b,e)oxipin
11-(3-Dimethylaminopropylidene)-6,11-dihydrodibenz(b,e)oxipin
11-(3-Dimethylaminopropylidene)-6,11-dihydrodibenz[b,e]oxepine hydrochloride
1229-29-4
1668-19-5
20917-44-6
229D294
25197-84-6
3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine
3-dibenzo[b,e]oxepin-11(6H)-ylidene-N,N-dimethylpropan-1-amine
3607-34-9
4698-39-9
5EH
851NLB57HQ
A804993
AB0109368
AC1LDI63
AC1O4WGB
Adapin
Adapine (TN)
AJ-08007
AK-60057
AK-70938
AKOS015895087
AKOS016014904
Aponal
Aponal (TN)
AX8126881
BC225584
BDBM112780
BG0175
BPBio1_000118
BRD-K36616567-003-01-5
BRD-K54462405-003-03-3
BSPBio_000106
C06971
C19H21NO
C19H21NO.HCl
CAS-1229-29-4
CCG-204434
CCG-220263
CCG-221643
CCRIS 9176
CHEBI:4711
CHEMBL1200462
CHEMBL860
Cidoxepin [INN]
Cidoxepina
Cidoxepinum
cis-N-(3-(6H-Dibenz(b,e)oxepin-11-yliden)propyl)-N,N-dimethylamin
CPD000058230
CS-2972
CU61C5RH24
Curatin
D 4526
D00814
D06EUH
D06FES
D07875
Deptran
Deptran (TN)
Dibenz(b,e)oxepin-delta(sup 11(6H),gamma)-propylamine, N,N-dimethyl-, hydrochloride
Dibenz(b,e)oxepin-delta(sup 11(6H)),gamma-propylamine, N,N-dimethyl-
Dibenz(b,e)oxepin-delta11(6H),gamma-propylamine, N,N-dimethyl-, hydrochloride
Dibenz(b,e)oxepin-delta11(6H),gamma-propylamine, N,N-dimethyl-, hydrochloride (8CI)
dimethyl({3-[(2E)-9-oxatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaen-2-ylidene]propyl})amine
DIMETHYL({3-[(2E)-9-OXATRICYCLO[9.4.0.0(3),?]PENTADECA-1(15),3,5,7,11,13-HEXAEN-2-YLIDENE]PROPYL})AMINE
dimethyl(3-{9-oxatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaen-2-ylidene}propyl)amine
doxepin
Doxepin (Hydrochloride)
Doxepin (INN)
Doxepin (Z)-isomer
Doxepin [INN:BAN]
Doxepin [USAN]
Doxepin for system suitability, European Pharmacopoeia (EP) Reference Standard
Doxepin HCl
Doxepin hydrochlorid
Doxepin hydrochloride (E)-isomer
Doxepin hydrochloride (USP)
Doxepin hydrochloride [USAN:USP]
Doxepin Hydrochloride [USAN]
Doxepin Hydrochloride 1.0 mg/ml in Methanol (as free base)
Doxepin Hydrochloride,
Doxepin hydrochloride, ~85% E-isomer basis, >=98% (GC), 15% Z-isomer basis, powder
Doxepin hydrochloride, European Pharmacopoeia (EP) Reference Standard
Doxepin hydrochloride, United States Pharmacopeia (USP) Reference Standard
Doxepin, (E)-
Doxepin, Hydrochloride
Doxepina
Doxepina [INN-Spanish]
Doxepine
Doxepine hydrochloride
Doxepinum
Doxepinum [INN-Latin]
DR000955
DSSTox_CID_25145
DSSTox_GSID_45145
DSSTox_RID_80701
DTXSID7022966
DTXSID8045145
E-DOXEPIN
EINECS 214-966-8
EU-0100339
GTPL1225
GTPL3958
HMS1568F08
HSDB 3069
HY-B0725
I06-0502
J10288
Jsp001539
KB-233534
KS-5094
L000699
Lopac-D-4526
Lopac0_000339
LP00339
LS-174582
LS-61638
LS-61639
MF 10
MF 10 HCl
MFCD00079135
MLS000069794
MLS001148235
MLS002207250
MLS002222181
MLS002548858
MOLI001594
MolPort-003-872-120
N,N-Dimethyldibenz(b,e)oxepin-delta(11(6H),gamma)-propylamine
N,N-Dimethyldibenz(b,e)oxepin-delta(sup 11(6H),gamma)-propylamine hydrochloride
NC00447
NCGC00015344-01
NCGC00015344-02
NCGC00015344-03
NCGC00015344-04
NCGC00024623-01
NCGC00024623-04
NCGC00093778-01
NCGC00093778-02
NCGC00162127-01
NCGC00261024-01
Novoxapin
Novoxapin hydrochloride
NSC-108160
Opera_ID_675
P-3693A
PL047943
Prestwick_187
Prestwick2_000263
Prestwick3_000263
Q-201044
Quitaxon
SAM002264608
SBB005916
SCHEMBL116895
SCHEMBL60287
Silenor
Sinequan
Sinequan (TN)
Sinequan, Zonalon
Sinequin
Sinquan (TN)
SMR000058230
SR-01000075551
SR-01000075551-1
ST025239
Tocris-0508
Toruan
Tox21_110130
Tox21_110130_1
Tox21_500339
trans-doxepin
trans-Doxepin hydrochloride
Triadapin
UNII-3U9A0FE9N5 component MHNSPTUQQIYJOT-SJDTYFKWSA-N
UNII-5ASJ6HUZ7D component ODQWQRRAPPTVAG-GZTJUZNOSA-N
UNII-851NLB57HQ
UNII-CU61C5RH24
US8629135, SW-07
Xepin (TN)
ZINC1331
Zonalon
Zonalon (TN)

Tentative approvals for DOXEPIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
➤ Sign Up	➤ Sign Up	6MG	TABLET; ORAL
➤ Sign Up	➤ Sign Up	3MG	TABLET; ORAL
➤ Sign Up	➤ Sign Up	6MG	TABLET; ORAL

US Patents and Regulatory Information for doxepin hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	070955-001	May 15, 1986		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Actavis Elizabeth	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	TABLET;ORAL	201951-001	Jul 26, 2013		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Watson Labs	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	072986-001	Mar 29, 1991		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Par Pharm	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	071595-001	Nov 9, 1987		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

Expired US Patents for doxepin hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	➤ Sign Up	➤ Sign Up
Pfizer	SINEQUAN	doxepin hydrochloride	CONCENTRATE;ORAL	017516-001	Approved Prior to Jan 1, 1982	➤ Sign Up	➤ Sign Up
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	➤ Sign Up	➤ Sign Up
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-005	Approved Prior to Jan 1, 1982	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

International Patents for doxepin hydrochloride

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Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007142811	➤ Sign Up
Japan	2016041757	➤ Sign Up
Canada	2687124	➤ Sign Up
World Intellectual Property Organization (WIPO)	2008011150	➤ Sign Up
Country	Document Number	Estimated Expiration