Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Mallinckrodt
Colorcon
McKinsey
McKesson

Last Updated: November 14, 2019

DrugPatentWatch Database Preview

Doxepin hydrochloride - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for doxepin hydrochloride and what is the scope of patent protection?

Doxepin hydrochloride is the generic ingredient in four branded drugs marketed by 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-six 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 Trial6MGTABLET; 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
Pharm Assoc DOXEPIN HYDROCHLORIDE doxepin hydrochloride CONCENTRATE;ORAL 075924-001 Jan 15, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 073055-001 Dec 28, 1990 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 070955-001 May 15, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-003 Approved Prior to Jan 1, 1982 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
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Baxter
Mallinckrodt
Express Scripts
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.