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Generated: March 20, 2019

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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.

Drug patent expirations by year for SILENOR
Pharmacology for SILENOR
Medical Subject Heading (MeSH) Categories for SILENOR
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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 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 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pernix Theraps Llc SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for SILENOR
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 3 mg and 6 mg ➤ Subscribe ➤ Try a Free Trial

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