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Last Updated: December 9, 2019

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DOXEPIN HYDROCHLORIDE Drug Profile

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When do Doxepin Hydrochloride patents expire, and when can generic versions of Doxepin Hydrochloride launch?

Doxepin Hydrochloride is a drug marketed by Ajanta Pharma Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Dava Pharms Inc, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Watson Labs Teva, Lannett Co Inc, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Actavis Elizabeth, and Mylan. and is included in fifty-three NDAs.

The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the doxepin hydrochloride profile page.

Drug patent expirations by year for DOXEPIN HYDROCHLORIDE
Recent Clinical Trials for DOXEPIN HYDROCHLORIDE

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SponsorPhase
Aalborg UniversityN/A
University of BalamandPhase 4
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all DOXEPIN HYDROCHLORIDE clinical trials

Recent Litigation for DOXEPIN HYDROCHLORIDE

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District Court Litigation
Case NameDate
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-15
Somaxon Pharmaceuticals Inc. v. Par Pharmaceutical Inc.2011-05-26
Somaxon Pharmaceuticals Inc. v. Actavis Elizabeth LLC2010-12-15

See all DOXEPIN HYDROCHLORIDE litigation

Pharmacology for DOXEPIN HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for DOXEPIN HYDROCHLORIDE
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 hydrochloride
(3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine;hydrochloride
(e)-doxepin hydrochloride
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-, hydrochloride
11-(3-(Dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin hydrochloride
11-(3-Dimethylaminopropylidene)-6,11-dihydrodibenz[b,e]oxepine hydrochloride
1229-29-4
20917-44-6
229D294
25197-84-6
4698-39-9
A804993
AB0109368
AC1O4WGB
Adapin
AKOS015895087
Aponal
BG0175
C19H21NO.HCl
CAS-1229-29-4
CCG-220263
CCG-221643
CHEBI:4711
CHEMBL1200462
CPD000058230
CS-2972
CU61C5RH24
Curatin
D 4526
D00814
Dibenz(b,e)oxepin-delta(sup 11(6H),gamma)-propylamine, N,N-dimethyl-, hydrochloride
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)
Doxepin (Hydrochloride)
Doxepin for system suitability, European Pharmacopoeia (EP) Reference Standard
Doxepin HCl
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, ~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
Doxepine hydrochloride
DSSTox_CID_25145
DSSTox_GSID_45145
DSSTox_RID_80701
DTXSID8045145
EINECS 214-966-8
EU-0100339
HMS1568F08
HY-B0725
I06-0502
J10288
Jsp001539
KS-5094
LP00339
LS-61639
MF 10 HCl
MFCD00079135
MLS000069794
MLS001148235
MLS002207250
MLS002222181
MLS002548858
MolPort-003-872-120
N,N-Dimethyldibenz(b,e)oxepin-delta(sup 11(6H),gamma)-propylamine hydrochloride
NC00447
NCGC00015344-03
NCGC00024623-04
NCGC00093778-01
NCGC00093778-02
NCGC00261024-01
Novoxapin
Novoxapin hydrochloride
NSC-108160
Opera_ID_675
P-3693A
Prestwick_187
Q-201044
Quitaxon
SAM002264608
SBB005916
SCHEMBL60287
Silenor
Sinequan
Sinequan (TN)
Sinequin
SMR000058230
SR-01000075551
SR-01000075551-1
SR-01000075551-5
ST025239
Toruan
Tox21_110130
Tox21_110130_1
Tox21_500339
trans-Doxepin hydrochloride
UNII-3U9A0FE9N5 component MHNSPTUQQIYJOT-SJDTYFKWSA-N
UNII-CU61C5RH24
Zonalon
Zonalon (TN)
Paragraph IV (Patent) Challenges for DOXEPIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
SILENOR TABLET;ORAL doxepin hydrochloride 022036 2010-09-16

US Patents and Regulatory Information for DOXEPIN HYDROCHLORIDE

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 071764-001 Feb 9, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 073055-001 Dec 28, 1990 DISCN No No   Start Trial   Start Trial   Start Trial
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-007 Apr 13, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Quantum Pharmics DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 072375-001 Mar 15, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-006 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-004 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Dow
Colorcon
Harvard Business School
Merck

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