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Generated: May 22, 2018

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DOXEPIN HYDROCHLORIDE - Generic Drug Details

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What are the generic 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. Thirty suppliers are listed for this compound. There are two tentative approvals for this compound.
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
(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 Up3MGTABLET; ORAL
➤ Sign Up➤ Sign Up6MGTABLET; ORAL
➤ Sign Up➤ Sign Up6MGTABLET; ORAL

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 070791-002 May 13, 1986 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 RX Yes Yes ➤ 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

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Expired US Patents for DOXEPIN HYDROCHLORIDE

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 CAPSULE;ORAL 016798-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-003 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for DOXEPIN HYDROCHLORIDE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,801,847 Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders ➤ Sign Up
9,463,181 Doxepin isomers and isomeric mixtures and methods of using the same to treat sleep disorders ➤ Sign Up
9,498,462 Doxepin trans isomers and isomeric mixtures and methods of using the same to treat sleep disorders ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Fuji
Cipla
QuintilesIMS
Julphar
Cantor Fitzgerald
Queensland Health
Daiichi Sankyo
Chubb

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