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Last Updated: November 17, 2019

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Duloxetine hydrochloride - Generic Drug Details

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What are the generic sources for duloxetine hydrochloride and what is the scope of freedom to operate?

Duloxetine hydrochloride is the generic ingredient in three branded drugs marketed by Lilly, Actavis Elizabeth, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Anchen Pharms, Apotex Inc, Aurobindo Pharma Ltd, Breckenridge, Cspc Ouyi, Hetero Labs Ltd Iii, Inventia, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Prinston Inc, Qingdao Baheal Pharm, Sun Pharm, Teva Pharms Usa, Torrent, Yaopharma Co Ltd, Zydus Hlthcare, Zydus Pharms, and Sun Pharma Global, and is included in twenty-four NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Duloxetine hydrochloride has seventeen patent family members in fourteen countries.

There are forty-two drug master file entries for duloxetine hydrochloride. Forty-five suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for duloxetine hydrochloride
Recent Clinical Trials for duloxetine hydrochloride

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

SponsorPhase
Janssen-Cilag International NVPhase 3
PfizerPhase 4
Southeastern Regional Medical CenterPhase 2

See all duloxetine hydrochloride clinical trials

Generic filers with tentative approvals for DULOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 60MG BASECAPSULE, DELAYED RELEASE; ORAL
  Start Trial  Start TrialEQ 30MG BASECAPSULE, DELAYED RELEASE; ORAL
  Start Trial  Start TrialEQ 20MG BASECAPSULE, DELAYED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for duloxetine hydrochloride
Synonyms for duloxetine hydrochloride
(+)-(S)-N-methyl-.gamma.-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride
(+)-(S)-N-Methyl-3-(1-naphthyloxy)-3-(2-thienyl)propanamine hydrochloride
(+)-(S)-N-Methyl-gamma-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride
(+)-N-methyl-gamma-(1-napthlenloxy)-2-thiophenepropan-amine hydrochloride
(3S)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine hydrochloride
(3S)-N-methyl-3-(naphthalen-1-yloxy)-3-(2-thienyl)propan-1-amine hydrochloride
(3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amin hydrochloride.
(3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine hydrochloride
(3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine;hydrochloride
(S)-(+)-DULOXETINE HYDROCHLORIDE
(S)-(+)-N-methyl-3-(1-naphthalenyloxy)-3-(2-thienyl) propanamine hydrochloride
(S)-(+)-N-Methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine Hydrochloride
(S)-Duloxetine (hydrochloride)
(S)-Duloxetine HCl
(S)-duloxetine hydrochloride
(S)-Duloxetine hydrochloride, >=98% (HPLC)
(S)-N-METHYL-3-(NAPHTHALEN-1-YLOXY)-3-(THIOPHEN-2-YL)PROPAN-1-AMINE HCL
(S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine hydrochloride
136434-34-9
2-Thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, hydrochloride, (gammaS)-
2-Thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, hydrochloride, (S)-
434D349
9044SC542W
AB0008489
AB2000488
AB23771
AC-924
AC1L1U0N
AC1Q3DMM
AK-72899
AKOS016340453
AN-253
ANW-52464
API0002507
Ariclaim
AX8017673
BFFSMCNJSOPUAY-LMOVPXPDSA-N
BR-72899
C18H19NOS.HCl
C18H20ClNOS
CAS-136434-34-9
CCG-101106
CD0196
CHEBI:31526
CHEMBL1200328
CPD000469136
CS-1993
Cymbalta
Cymbalta (TN)
Cymbalta|||Dulane 20|||LY 248686 HCl
D-170
D01179
D4223
DSSTox_CID_26443
DSSTox_GSID_46443
DSSTox_RID_81618
DTXSID9046443
Dulane 20
Duloxetine (hydrochloride)
Duloxetine for system suitability, European Pharmacopoeia (EP) Reference Standard
Duloxetine HCl
Duloxetine HCl (Cymbalta)
Duloxetine hydrochloride (JAN/USAN)
Duloxetine hydrochloride [USAN]
Duloxetine Hydrochloride 1.0 mg/ml in Methanol (as free base)
Duloxetine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Duloxetine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Duloxetine hydrochloride, United States Pharmacopeia (USP) Reference Standard
duloxetine hydrochlorise
Duloxetine-D3 hydrochloride solution, 100 mug/mL in methanol (as free base), ampule of 1 mL, certified reference material
Duloxetine, HCl
EBD2816
EBD29778
FT-0648818
HY-B0161A
J10476
KB-50492
KS-1168
LS-172959
LY 248686 HCl
LY-248686
LY-264453
LY248686 HCl
methyl[(3S)-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl]amine hydrochloride
MLS001401452
MLS006010054
MolPort-003-666-661
NC00356
NCGC00164559-01
NCGC00164559-03
NSC-744012
NSC-759112
NSC744012
NSC759112
Pharmakon1600-01505387
PubChem1909
Q-102508
S-4928
s2084
SAM001246523
SC-00924
SMR000469136
ST24026653
SW197393-3
TC-141209
Tox21_112188
Tox21_112188_1
UNII-9044SC542W
Xeristar
Yentreve (TN)
Paragraph IV (Patent) Challenges for DULOXETINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
CYMBALTA CAPSULE, DELAYED REL PELLETS;ORAL duloxetine hydrochloride 021427 2012-05-10
CYMBALTA CAPSULE, DELAYED REL PELLETS;ORAL duloxetine hydrochloride 021427 2008-08-04

US Patents and Regulatory Information for duloxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ajanta Pharma Ltd DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 208706-004 Mar 11, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Marksans Pharma DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090723-001 Dec 11, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Prinston Inc DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 206653-002 May 18, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 204815-002 Mar 23, 2017 AB RX 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 duloxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004   Start Trial   Start Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for duloxetine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0273658 SPC/GB05/003 United Kingdom   Start Trial PRODUCT NAME: DULOXETINE AND PHARMACUETICALLY ACCEPTABLE ACID ADDITION SALTS THEREOF, AND IN PARTICULAR DULOXETINE HYDROCHLORIDE; REGISTERED: UK EU/1/04/280/001 20040811; UK EU/1/04/280/002 20040811; UK EU/1/04/280/003 20040811; UK EU/1/04/280/004 20040811; UK EU/1/04/280/005 20040811; UK EU/1/04/280/006 20040811
0273658 C300171 Netherlands   Start Trial PRODUCT NAME: DULOXETINE EN FARMACEUTISCH AANVAARDBARE ZUURADDITIEZOUTEN DAARVAN, EN IN HET BIJZONDER DULOXETINE HYDROCHLORIDE; NATL REGISTRATION NO/DATE: EU/1/04/280/001-006 20040811
0273658 2005C/001 Belgium   Start Trial PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School

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