Duloxetine Hydrochloride

Sold as Cymbalta, Drizalma Sprinkle, Duloxetine Hydrochloride. Every FDA application for this active ingredient: 6 branded and 26 generic.

As of Nov 15, 2026, FDA lists 32 applications for Duloxetine Hydrochloride (sold as Cymbalta, Drizalma Sprinkle, Duloxetine Hydrochloride), first approved Aug 3, 2004, with 8 new uses approved and 0 published complete response letters.

First approved: Aug 3, 2004
Applications: 32
New uses approved: 8
Complete response letters: 0
Medicare spending, 2025: $344M
First approved in the EU: Aug 11, 2004
First approved in Japan: Jan 20, 2010

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Duloxetine HCl	Part D	$323M	+4%	2,783,264
Drizalma Sprinkle	Part D	$12.7M	+972%	13,870
Cymbalta	Part D	$8.2M	-48%	3,909

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

DULOXETINE HCL DR 120 MG CAP: $5.66 per unitGeneric · new this year
DULOXETINE HCL DR 20 MG CAP: $0.118 per unitGeneric · +10% in a year
DULOXETINE HCL DR 30 MG CAP: $0.099 per unitGeneric · +27% in a year
DULOXETINE HCL DR 40 MG CAP: $1.21 per unitGeneric · -2% in a year
DULOXETINE HCL DR 60 MG CAP: $0.137 per unitGeneric · +46% in a year
DULOXETINE HCL DR 90 MG CAP: $5.65 per unitGeneric · new this year
DRIZALMA SPRINKLE DR 20 MG CAP: $7.07 per unitBrand · -2% in a year
DRIZALMA SPRINKLE DR 30 MG CAP: $7.27 per unitBrand · +2% in a year
DRIZALMA SPRINKLE DR 40 MG CAP: $7.16 per unitBrand · 0% in a year
DRIZALMA SPRINKLE DR 60 MG CAP: $7.15 per unitBrand · +1% in a year

Approvals in the EU (EMA)

First approved in the EU the same month as the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Duloxetine Zentiva, genericZentiva k.s. · Aug 20, 2015
Duloxetine Viatris (previously Duloxetine Mylan), genericViatris Limited · Jun 19, 2015
Duloxetine LillyEli Lilly Nederland B.V. · Dec 8, 2014
Duloxetine Boehringer IngelheimBoehringer Ingelheim International GmbH · Oct 8, 2008 · withdrawn
CymbaltaEli Lilly Nederland B.V. · Dec 17, 2004
Nodetrip (previously Xeristar)Esteve Pharmaceuticals, S.A. · Dec 17, 2004 · withdrawn
Yentreve, new substanceEli Lilly Nederland B.V. · Aug 11, 2004
AriclaimEli Lilly Nederland B.V. · Aug 11, 2004 · withdrawn

Approvals in Japan (PMDA)

First approved in Japan 66 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

CymbaltaDrugs with a new additional indication for the treatment of pain associated with osteoarthritis. · Shionogi & Co., Ltd. · Dec 19, 2016 · Review report
CymbaltaDrugs with a new additional indication for the treatment of pain associated with chronic low back pain. · Shionogi & Co., Ltd. · Mar 18, 2016
CymbaltaDrugs with a new additional indication and a new dosage for the treatment of pain associated with fibromyalgia. · Shionogi & Co., Ltd. · May 26, 2015
CymbaltaDrugs with a new additional indication for the treatment of pain associated with diabetic neuropathy. · Shionogi & Co., Ltd. · Feb 22, 2012
Cymbalta, new ingredientDrugs with a new active ingredient indicated for the treatment of depression. · Shionogi & Co., Ltd. · Jan 20, 2010

Clinical Trials

58 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic NeuropathyDiabetic Peripheral Neuropathy, Painful Diabetic Neuropathy · Assiut University	Phase 2	Not yet recruiting	Oct 20, 2026
Efficacy of Topical Lidocaine Gel vs. Oral Duloxetine for Painful Diabetic Peripheral NeuropathyPainful Diabetic Neuropathy (PDN), Diabetic Neuropathies · Wah Medical college , POF hospital	Phase 4	Not yet recruiting	Sep 2, 2026
Modality Choice Before and After Failure for the Treatment of Painful Diabetic NeuropathyPainful Diabetic Neuropathy (PDN), Diabetic Nephropathies · University of Michigan	Phase 4	Not yet recruiting	Aug 31, 2026
Pharmacopuncture for Aromatase Inhibitor Induced Arthralgia (AIA)Breast Cancer, Aromatase Inhibitor · Ilsan Cha hospital	Not applicable	Recruiting	Aug 27, 2026
Efficacy and Safety of Low-Dose Duloxetine Plus Alpha-Lipoic Acid Versus Standard-Dose Duloxetine in Painful Diabetic Peripheral NeuropathyPainful Diabetic Peripheral Neuropathy · Bangladesh Medical University	Not applicable	Not yet recruiting	Aug 25, 2026
Personalized Analgesia Through Central Nervous System Engagement to Unlock PerformanceKnee Osteoarthritis (Knee OA), Chronic Pain · Benedict Alter	Phase 4	Recruiting	Aug 12, 2026
Biomarkers and Pharmacogenomics for Precision Depression TherapyDepression / Major Depressive Disorder · The Fourth Affiliated Hospital of Zhejiang University School of Medicine	Not applicable	Not yet recruiting	Jul 31, 2026
Algorithm-informed Decision-making to Advance Pain TreatmentChronic Low-back Pain · University of Michigan	Not applicable	Recruiting	Jul 28, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Aug 3, 2004	CymbaltaNDA 21427 · New molecular entity	Lilly	37	Discontinued
Sep 3, 2004	CymbaltaNDA 21733 · TYPE 6	Lilly	0	Marketed
Jun 13, 2008	CymbaltaNDA 22148 · TYPE 6	Lilly	0	Marketed
Nov 4, 2010	CymbaltaNDA 22516 · TYPE 6	Lilly	0	Marketed
Dec 11, 2013	Duloxetine HydrochlorideANDA 90723	Pharmazone	1	Discontinued
Dec 11, 2013	Duloxetine HydrochlorideANDA 90774	Torrent	0	Discontinued
Dec 11, 2013	Duloxetine HydrochlorideANDA 90778	Aurobindo Pharma Ltd	15	Marketed
Dec 11, 2013	Duloxetine HydrochlorideANDA 90783	Teva Pharms USA	8	Discontinued
Dec 11, 2013	Duloxetine HydrochlorideANDA 90694	Lupin	14	Marketed
Dec 11, 2013	Duloxetine HydrochlorideANDA 90745	Sun Pharm	9	Discontinued
Dec 17, 2013	Duloxetine HydrochlorideANDA 90776	Actavis Elizabeth	7	Marketed
Jan 8, 2014	Duloxetine HydrochlorideANDA 90728	Zydus Pharms	2	Marketed
Jan 8, 2014	Duloxetine HydrochlorideANDA 90739	Zydus Hlthcare	9	Marketed
Jun 9, 2014	Duloxetine HydrochlorideANDA 202949	Alembic	10	Marketed
Jun 11, 2014	Duloxetine HydrochlorideANDA 202045	Apotex	10	Discontinued
Jun 11, 2014	Duloxetine HydrochlorideANDA 203088	Breckenridge	5	Marketed
Aug 26, 2015	Duloxetine HydrochlorideANDA 203197	Alkem Labs Ltd	7	Marketed
Oct 28, 2015	Duloxetine HydrochlorideANDA 90780	Everest Lifesciences	0	Discontinued
Oct 28, 2015	Duloxetine HydrochlorideANDA 202336	Inventia	1	Marketed
Aug 3, 2016	Duloxetine HydrochlorideANDA 204343	Hetero Labs Ltd Iii	6	Marketed
Jan 6, 2017	Duloxetine HydrochlorideANDA 208706	Ajanta Pharma Ltd	8	Marketed
Mar 23, 2017	Duloxetine HydrochlorideANDA 204815	Macleods Pharms	1	Marketed
May 18, 2017	Duloxetine HydrochlorideANDA 206653	Prinston	4	Marketed
Oct 16, 2018	Duloxetine HydrochlorideANDA 211310	Cspc Ouyi	0	Marketed
Apr 17, 2019	Duloxetine HydrochlorideANDA 210599	Qingdao Baheal Pharm	1	Marketed
Jul 19, 2019	Drizalma SprinkleNDA 212516 · New formulation or manufacturer	Sun Pharm	3	Marketed
Aug 16, 2019	Duloxetine HydrochlorideANDA 207219	Yaopharma Co Ltd	0	Discontinued
Feb 11, 2021	Duloxetine HydrochlorideANDA 212328	Sunshine	0	Marketed
Feb 27, 2026	Duloxetine HydrochlorideNDA 219131 · New formulation or manufacturer	Almatica	1	Marketed
—	Duloxetine HydrochlorideANDA 90669	Impax Labs Inc	0	Discontinued
—	Duloxetine HydrochlorideANDA 90773	Wockhardt	0	Discontinued
—	Duloxetine HydrochlorideANDA 90775	Sandoz	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA