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Last Updated: December 9, 2019

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Doxepin hydrochloride - Generic Drug Details

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What are the generic drug sources for doxepin hydrochloride and what is the scope of freedom to operate?

Doxepin hydrochloride is the generic ingredient in four branded drugs 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, Pfizer, Lannett Co Inc, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Mylan, Actavis Elizabeth, and Currax, and is included in fifty-seven NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doxepin hydrochloride has sixteen patent family members in four countries.

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

Recent Clinical Trials for doxepin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

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

Identify potential future generic entrants

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

Generic filers with tentative approvals for DOXEPIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial6MGTABLET; ORAL
  Start Trial  Start Trial3MGTABLET; ORAL
  Start Trial  Start Trial3MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 RX Yes No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071521-001 Feb 18, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071502-001 Feb 18, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs Teva DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 072987-001 Mar 29, 1991 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan ZONALON doxepin hydrochloride CREAM;TOPICAL 020126-001 Apr 1, 1994 RX Yes Yes   Start Trial   Start Trial   Start Trial
Quantum Pharmics DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 070932-001 Sep 29, 1987 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
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010   Start Trial   Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010   Start Trial   Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010   Start Trial   Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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