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SILENOR Drug Profile

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

Silenor is a drug marketed by Pernix Theraps Llc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has fifteen 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-eight suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for SILENOR

International Patents:	15
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	56
Clinical Trials:	2
Patent Applications:	669
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

Pharmacology for SILENOR

Drug Class

Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for SILENOR

Antidepressive Agents, Tricyclic

Histamine Antagonists

Sleep Aids, Pharmaceutical

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010		RX	Yes	No			Y
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010		RX	Yes	Yes
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010		RX	Yes	No

Expired US Patents for SILENOR

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
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010

Paragraph IV (Patent) Challenges for SILENOR

Drugname	Dosage	Strength	RLD	Date
	Tablets	3 mg and 6 mg

International Patents for SILENOR

Country	Patent Number	Estimated Expiration
Japan	2016041757
Japan	2013237694
Japan	2009537554