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SILENOR Drug Profile

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

Silenor is a drug marketed by Currax and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in four countries.

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

Summary for SILENOR

International Patents:	16
US Patents:	10
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	59
Clinical Trials:	2
Patent Applications:	719
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SILENOR
Drug Sales Revenues:	Drug sales revenues for SILENOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SILENOR
DailyMed Link:	SILENOR at DailyMed

Drug patent expirations by year for SILENOR

Recent Clinical Trials for SILENOR

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

Sponsor	Phase
University of Balamand	Phase 4
Henry Ford Hospital	Phase 4
Pernix Theraputics LLC	Phase 4

See all SILENOR clinical trials

Recent Litigation for SILENOR

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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 LLC	2010-12-15

See all SILENOR litigation

Pharmacology for SILENOR

Drug Class	Tricyclic Antidepressant

Synonyms for SILENOR

(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
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
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)

US Patents and Regulatory Information for SILENOR

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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
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010		RX	Yes	No	Start Trial	Start Trial				Start Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010		RX	Yes	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 SILENOR

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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	022036-002	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