Viewing data from:

CYMBALTA

NDA

DULOXETINE HYDROCHLORIDE | N021427 | ELI LILLY AND CO

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Kathy Lynn Bramel Easterday FDA-2026-P-1831 · 3 docket documents Kathy Lynn Bramel Easterday filed this petition under sections 502, 505, 701, and related provisions of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner require NDA holders and generic manufacturers of Cymbalta (duloxetine hydrochloride) to develop and make available sta	505(q)	2026-02-19	Open	Kathy Lynn Bramel Easterday

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

270 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 213 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer NCT04137107	Phase 2/3	Active	Alliance for Clinical Trials in Oncology	220	2020-06-17 → 2026-12-31
Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)NCT04245436	Phase 4	Recruiting	University of Cincinnati	60	2020-01-01 → 2025-08
Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)NCT04245748	Phase 4	Recruiting	University of Cincinnati	84	2020-03-01 → 2025-12-31
Open Label Phase III Duloxetine Study for Stress Urinary Incontinence NCT00191204	Phase 3	Completed	Eli Lilly and Company	363	2001-09 → 2006-05
Duloxetine Versus Placebo in the Treatment of FMS NCT00233025	Phase 3	Completed	Eli Lilly and Company	320	2005-09 → 2007-06
Duloxetine for Post Laparoscopic Shoulder Pain NCT03249168	Phase 3	Completed	Assiut University	60	2017-10-01 → 2019-01-01
A Study for Patient With Chronic Low Back Pain NCT00767806	Phase 3	Completed	Eli Lilly and Company	401	2008-09 → 2009-07
Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus Erythematosus NCT01269866	N/A	Completed	Dr. Jesus Gutierrez Stone	26	2010-12 → 2012-05
Duloxetine in Osteoarthritis (OA) Pain NCT01558700	Phase 4	Completed	Northwestern University	40	2012-03 → 2014-08
A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression NCT02417064	Phase 3	Completed	Janssen Research & Development, LLC	346	2015-08-10 → 2018-02-20

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$7.98

per ea

Lowest NADAC/Unit

$7.98

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00002323560CYMBALTA 20 MG CAPSULE	$7.98	EA	Brand	$0.1227	2025-07-23

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$209.97

Highest Price

$845.73

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00002-3235-60CYMBALTA 20MG CAP	$502.91	FSS	Eli Lilly & Company	09/28/2030
00002-3235-60CYMBALTA 20MG CAP	$374.57	Big4	Eli Lilly & Company	09/28/2030
00002-3240-30CYMBALTA 30MG CAP	$281.91	FSS	Eli Lilly & Company	09/28/2030
00002-3240-30CYMBALTA 30MG CAP	$209.97	Big4	Eli Lilly & Company	09/28/2030
00002-3240-90CYMBALTA 30MG CAPSULES	$845.73	FSS	Eli Lilly & Company	09/28/2030
00002-3240-90CYMBALTA 30MG CAPSULES	$629.90	Big4	Eli Lilly & Company	09/28/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Cymbalta (2024)

Total Spending

$15.9M

Total Claims

23,811

Beneficiaries

4,512

Avg Cost/Unit

$8.98

Spending Trend

$22.0M(2019)→$21.9M(2020)→$20.6M(2021)→$19.4M(2022)→$18.1M(2023)→$15.9M(2024)

YoY Change:-6.2%

5yr CAGR:+1.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain34 active DMFs15 inactive

28 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDDULOXETINE HYDROCHLORIDE

DMF 202962007

MSN LABORATORIES PRIVATE LTDDULOXETINE HYDROCHLORIDE USP [ROUTE CODE - DX"]

DMF 209962007

MATRIX PHARMACORP PRIVATE LTDDULOXETINE HYDROCHLORIDE USP

DMF 214782008

TORRENT PHARMACEUTICALS LTDDULOXETINE HYDROCHLORIDE USP

DMF 214852008

LUPIN LTDDULOXETINE HYDROCHLORIDE USP

DMF 215242008

WOCKHARDT LTDDULOXETINE HYDROCHLORIDE USP

DMF 216042008

ORBION PHARMACEUTICALS PRIVATE LTDDULOXETINE HYDROCHLORIDE (NON-STERILE BULK API)

DMF 216352008

SUN PHARMACEUTICAL INDUSTRIES LTDDULOXETINE HYDROCHLORIDE USP

DMF 217522008

APITORIA PHARMA PRIVATE LTDDULOXETINE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 217672008

SIGNA SA DE CVDULOXETINE HYDROCHLORIDE USP

DMF 218332008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDDULOXETINE HYDROCHLORIDE, USP

DMF 230512009

ALEMBIC PHARMACEUTICALS LTDDULOXETINE HYDROCHLORIDE USP

DMF 237022010

ALKEM LABORATORIES LTDDULOXETINE HYDROCHLORIDE

DMF 246852011

SCI PHARMTECH INCDULOXETINE HYDROCHLORIDE

DMF 249392011

MACLEODS PHARMACEUTICALS LTDDULOXETINE HYDROCHLORIDE

DMF 250362011

HETERO DRUGS LTDDULOXETINE HYDROCHLORIDE

DMF 252802011

JUBILANT BIOSYS LTDDULOXETINE HYDROCHLORIDE

DMF 258902012

ZYDUS LIFESCIENCES LTDDULOXETINE HYDROCHLORIDE USP (PROCESS-II)

DMF 283902014

LUPIN LTDDULOXETINE HYDROCHLORIDE USP (PROCESS B)

DMF 289612015

ZHEJIANG LIAOYUAN PHARMACEUTICALS CO LTDDULOXETINE HYDROCHLORIDE

DMF 295002015

MACLEODS PHARMACEUTICALS LTDDULOXETINE HYDROCHLORIDE DELAYED-RELEASE PELLETS

DMF 298992015

HEC PHARM CO LTDDULOXETINE HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE

DMF 301722016

ZHEJIANG YONGTAI PHARMACEUTICAL CO LTDDULOXETINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE

DMF 301742016

ALEMBIC PHARMACEUTICALS LTDDULOXETINE HYDROCHLORIDE USP (DUX PROCES)

DMF 303902016

RL FINE CHEM PVT LTDDULOXETINE HYDROCHLORIDE

DMF 330722018

APITORIA PHARMA PRIVATE LTDDULOXETINE HYDROCHLORIDE USP (PROCESS II)

DMF 336332019

SHANGHAI WONDER PHARMACEUTICAL CO LTDDULOXETINE HYDROCHLORIDE

DMF 346782020

MSN LABORATORIES PRIVATE LTDDULOXETINE HYDROCHLORIDE USP

DMF 358052021

MOEHS IBERICA SLDULOXETINE HYDROCHLORIDE

DMF 368342022

AJANTA PHARMA LTDDULOXETINE HYDROCHLORIDE USP

DMF 374582022

SHODHANA LABORATORIES PRIVATE LTDDULOXETINE HYDROCHLORIDE [USP]

DMF 401652024

IPCA LABORATORIES LTDDULOXETINE HYDROCHLORIDE USP

DMF 402822024

SHANKUS PHARMA PRIVATE LTDDULOXETINE HYDROCHLORIDE EP/BP

DMF 432202025

SHANKUS PHARMA PRIVATE LTDDULOXETINE HYDROCHLORIDE USP

DMF 434512026

CADILA HEALTHCARE LTDInactiveDULOXETINE HYDROCHLORIDE USP

DMF 196312006

MATRIX LABORATORIES LTDInactiveDULOXETINE HYDROCHLORIDE

DMF 198602006

OLON SPAInactiveDULOXETINE HYDROCHLORIDE

DMF 199742006

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveDULOXETINE HYDROCHLORIDE

DMF 213852008

RANBAXY LABORATORIES LTDInactiveDULOXETINE HYDROCHLORIDE DRUG SUBSTANCE

DMF 218382008

ZHEJIANG HISOAR PHARMACEUTICAL CO LTD CHUANNAN BRANCHInactiveDULOXETINE HYDROCHLORIDE

DMF 220862008

CADILA PHARMACEUTICALS LTDInactiveDULOXETINE HYDROCHLORIDE

DMF 228672009

ERREGIERRE SPAInactiveDULOXETINE HYDROCHLORIDE EP-USP

DMF 231332009

SCI PHARMTECH INCInactiveDULOXETINE HYDROCHLORIDE (FROM (S)-MMAA-OME)

DMF 234402010

CADILA HEALTHCARE LTDInactiveDULOXETINE HYDROCHLORIDE USP (DUB ROUTE)

DMF 242742010

ESTEVE QUIMICA SAInactiveDULOXETINE HYDROCHLORIDE

DMF 246592011

JIANGSU HANSOH PHARMACEUTICAL CO LTDInactiveDULOXETINE HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE

DMF 256252011

NOSCH LABS PRIVATE LTDInactiveDULOXETINE HYDROCHLORIDE, USP

DMF 267892013

SHODHANA LABORATORIES LTDInactiveDULOXETINE HYDROCHLORIDE USP

DMF 283982014

CTX LIFE SCIENCES PVT LTDInactiveDULOXETINE HYDROCHLORIDE USP

DMF 295402015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

36 letters from Drugs@FDA

Date	Submission	Document
Aug 22, 2023	SUPPL -57	View Letter (PDF)
Aug 22, 2023	SUPPL -55	View Letter (PDF)
Sep 21, 2021	SUPPL -56	View Letter (PDF)
Oct 2, 2020	SUPPL -53	View Letter (PDF)
Apr 21, 2020	SUPPL -52	View Letter (PDF)
Oct 9, 2019	SUPPL -51	View Letter (PDF)
Dec 27, 2017	SUPPL -50	View Letter (PDF)
Jan 10, 2017	SUPPL -49	View Letter (PDF)
Sep 2, 2016	SUPPL -48	View Letter (PDF)
Jun 22, 2015	SUPPL -46	View Letter (PDF)
Nov 28, 2014	SUPPL -37	View Letter (PDF)
Nov 28, 2014	SUPPL -42	View Letter (PDF)
Oct 21, 2014	SUPPL -43	View Letter (PDF)
Oct 21, 2014	SUPPL -44	View Letter (PDF)
Jul 21, 2014	SUPPL -45	View Letter (PDF)
Oct 22, 2012	SUPPL -40	View Letter (PDF)
Oct 22, 2012	SUPPL -41	View Letter (PDF)
Aug 28, 2012	SUPPL -38	View Letter (PDF)
Aug 28, 2012	SUPPL -32	View Letter (PDF)
Sep 7, 2011	SUPPL -39	View Letter (PDF)
Apr 15, 2011	SUPPL -36	View Letter (PDF)
Mar 8, 2011	SUPPL -31	View Letter (PDF)
Nov 27, 2009	SUPPL -30	View Letter (PDF)
Mar 24, 2009	SUPPL -28	View Letter (PDF)
Mar 24, 2009	SUPPL -21	View Letter (PDF)
Mar 24, 2009	SUPPL -27	View Letter (PDF)
Feb 3, 2009	SUPPL -29	View Letter (PDF)
Dec 3, 2007	SUPPL -15	View Letter (PDF)
Dec 3, 2007	SUPPL -17	View Letter (PDF)
Aug 7, 2007	SUPPL -18	View Letter (PDF)
Mar 6, 2007	SUPPL -13	View Letter (PDF)
Mar 6, 2007	SUPPL -9	View Letter (PDF)
Mar 6, 2007	SUPPL -11	View Letter (PDF)
Jun 14, 2006	SUPPL -7	View Letter (PDF)
Feb 23, 2005	SUPPL -2	View Letter (PDF)
Aug 10, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 20MG BASE

RLD

0 patents0 exclusivities▴

CAPSULE, DELAYED REL PELLETS;ORAL | Approved: Aug 3, 2004

No patent or exclusivity listings for this strength.

#002 — EQ 30MG BASE

RLD

0 patents0 exclusivities▾

CAPSULE, DELAYED REL PELLETS;ORAL | Approved: Aug 3, 2004

#004 — EQ 60MG BASE

RLD

0 patents0 exclusivities▾

CAPSULE, DELAYED REL PELLETS;ORAL | Approved: Aug 3, 2004