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Generated: December 14, 2018

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CYMBALTA Drug Profile

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When do Cymbalta patents expire, and what generic alternatives are available?

Cymbalta is a drug marketed by Lilly and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has sixteen patent family members in fourteen countries.

The generic ingredient in CYMBALTA is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.

Drug patent expirations by year for CYMBALTA
Synonyms for CYMBALTA
(+)-(S)-N-Methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamin
(+)-(S)-N-Methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine monohydrochloride
(3S)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine
(3S)-N-methyl-3-(naphthalen-1-yloxy)-3-(2-thienyl)propan-1-amine
(3s)-N-Methyl-3-(Naphthalen-1-Yloxy)-3-(Thiophen-2-Yl)propan-1-Amine
(3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-yl-propan-1 amine
(3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-yl-propan-1-amine
(3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-yl-propan-1amine
(3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine
(S)-(+)-N-methyl-3-(1-naphthaleneoxy)-3-(2-thienyl)propanamine
(S)-(+)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine
(S)-Duloxetine
(S)-Duloxetine;LY248686
(S)-N-methyl-3-(1-naphthalenyloxy)-3-(2-thienyl) propanamine
(S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine
(S)-N-Methyl-gamma-(1-naphthalenyloxy)-2-thiophenepropanamine
116539-59-4
2-Thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, (gammaS)-
2-Thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, (S)-
29E
539D594
AB00639911_15
AB00639911_16
AB00639911-13
AC-15704
AC1L1U0Q
AC1Q57H7
AJ-26827
AK-75788
AKOS015851058
AN-15424
ANW-63714
Ariclaim
AX8017669
BC209438
BDBM84745
C18H19NOS
CAS_136434-34-9
CCG-100763
CHEBI:36795
CHEMBL1175
CM14423
CPD000449282
CS-2885
CTK8B9954
Cymbalta (TN)
D01AXB
D07880
DB00476
DTXSID6048385
duloxetine
Duloxetine (INN)
Duloxetine [INN:BAN]
Duloxetine Boehringer Ingelheim
duloxetine, (+)-isomer
FT-0657836
GTPL202
HE059415
HE222121
HE299105
HMS2051I05
HSDB 7368
HY-B0161
J-003455
J-523680
KB-211921
LS-172322
LY 248686
LY-248686
LY248686
Methyl-[3-(naphthalen-1-yloxy)-3-thiophen-2-yl-propyl]-amine 1HCl salt
methyl[(3S)-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl]amine
MFCD06801358
MLS000758267
MLS001423946
MolPort-003-847-038
N-Methyl-gama-(1-naphthalenyloxy)-2-thiophenepropanamine
NC00013
NCGC00164559-01
NCGC00164559-02
NCGC00164559-04
O5TNM5N07U
PDSP1_000969
PDSP1_001385
PDSP2_000953
PDSP2_001369
RL00632
RTC-064103
SAM001247059
SBI-0206832.P001
SC-19047
SCHEMBL8291
SMR000449282
UNII-O5TNM5N07U
VA11973
Xeristar
Yentreve
Yentreve (TN)
ZEUITGRIYCTCEM-KRWDZBQOSA-N
ZINC1536779

US Patents and Regulatory Information for CYMBALTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 CYMBALTA

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

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Paragraph IV (Patent) Challenges for CYMBALTA
Drugname Dosage Strength RLD Date
➤ Subscribe Delayed-release Capsules 40 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Delayed-release Capsules 20 mg, 30 mg and 60 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for CYMBALTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00171 Netherlands ➤ Sign Up 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
05C/001 Belgium ➤ Sign Up PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
C/GB05/003 United Kingdom ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
Accenture
AstraZeneca
Covington
Boehringer Ingelheim
Baxter
Moodys
Fish and Richardson

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