Yentreve Eli Lilly Nederland B.V. · Authorised · authorised 11 Aug 2004 · ATC N06AX21
Therapeutic indication (EMA)
Yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).
Active substance
Duloxetine
- SFDA 12
- US FDA 29
- EMA 9
- Health Canada 36
- US price lines 8
- NHS prices 6
- Safety 17
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| CYMBALTA 60MG HARD GASTRO-RESISTANT CAP | 60 mg | Gastro-resistant capsule · Oral use | 28 Blister | SAR 112.40 | NCE · Prescription | ELI LILLY NEDERLAND B.V. | Valid |
| Cymbatex | 30 mg | Gastro-resistant capsule, hard · Oral use | 30 Blister | SAR 36.10 | Generic · Prescription | Eva pharma for Industry | Valid |
| Cymbatex | 60 mg | Gastro-resistant capsule, hard · Oral use | 30 Blister | SAR 72.20 | Generic · Prescription | Eva pharma for Industry | Valid |
| DELAXIN 30 mg delayed-release capsule | 30 mg | Gastro-resistant capsule, hard · Oral use | 30 Tablet Container | SAR 47.75 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| DELAXIN 60 mg delayed-release capsule | 60 mg | Gastro-resistant capsule, hard · Oral use | 30 Tablet Container | SAR 95.55 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Durotine | 30 mg | Gastro-resistant capsule, hard · Oral use | 30 Blister | SAR 36.10 | Generic · Prescription | Saudi Amarox | Valid |
| Durotine | 60 mg | Gastro-resistant capsule, hard · Oral use | 30 Blister | SAR 72.20 | Generic · Prescription | Saudi Amarox | Valid |
| MODEXA 30 mg gastro-resistant capsule | 30 mg | Capsule, hard · Oral use | 14 Blister | SAR 20.05 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| MODEXA 60 mg gastro-resistant capsule | 60 mg | Capsule, hard · Oral use | 28 Blister | SAR 80.25 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| SYNODEX | 60 mg | Capsule, hard · Oral use | 30 Blister | SAR 72.20 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
| Synodex | 30 mg | Capsule, hard · Oral use | 30 Blister | SAR 36.10 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
| CYMBALTA 30MG HARD GASTRO-RESISTANT CAP. | 30 mg | Gastro-resistant capsule · Oral use | 14 Blister | SAR 40.10 | Generic · Prescription | ELI LILLY NEDERLAND B.V. | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ACUTE BIPOLAR I DEPRESSION; ALZHEIMER / DEMENTIA; ANXIETY DISORDERS; AUTISM SPECTRUM DISORDER; DEPRESSION; DIABETIC NEUROPATHY; FIBROMYALGIA; LOW BACK PAIN; MENOPAUSE; MENSTRUAL DISORDERS; NARCOLEPSY AND CATAPLEXY; NEUROPATHIC PAIN; OSTEOARTHRITIS; PAIN MANAGEMENT IN CANCER PATIENTS; SICKLE CELL DISEASE - PAIN MANAGEMENT; URINARY INCONTINENCE AND OVERACTIVE BLADDER
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CYMBALTA | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | LILLY | Prescription | 3 Sep 2004 |
| CYMBALTA | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | LILLY | Prescription | 13 Jun 2008 |
| CYMBALTA | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | LILLY | Prescription | 4 Nov 2010 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 40MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | LUPIN | Prescription | 11 Dec 2013 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | AUROBINDO PHARMA LTD | Prescription | 11 Dec 2013 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | ACTAVIS ELIZABETH | Prescription | 17 Dec 2013 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | ZYDUS PHARMS | Prescription | 8 Jan 2014 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE; EQ 40MG BASE | capsule, delayed rel pellets · oral | ZYDUS HLTHCARE | Prescription | 8 Jan 2014 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | ALEMBIC | Prescription | 9 Jun 2014 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE; EQ 40MG BASE | capsule, delayed rel pellets · oral | BRECKENRIDGE | Prescription | 11 Jun 2014 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | ALKEM LABS LTD | Prescription | 26 Aug 2015 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | INVENTIA | Prescription | 28 Oct 2015 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | HETERO LABS LTD III | Prescription | 3 Aug 2016 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE; EQ 40MG BASE | capsule, delayed rel pellets · oral | AJANTA PHARMA LTD | Prescription | 6 Jan 2017 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | MACLEODS PHARMS | Prescription | 23 Mar 2017 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | PRINSTON INC | Prescription | 18 May 2017 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | CSPC OUYI | Prescription | 16 Oct 2018 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | QINGDAO BAHEAL PHARM | Prescription | 17 Apr 2019 |
| DRIZALMA SPRINKLE | EQ 20MG BASE; EQ 30MG BASE; EQ 40MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | SUN PHARM | Prescription | 19 Jul 2019 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | SUNSHINE | Prescription | 11 Feb 2021 |
| DULOXETINE HYDROCHLORIDE | EQ 80MG BASE; EQ 90MG BASE; EQ 120MG BASE | capsule, delayed rel pellets · oral | ALMATICA | Prescription | 27 Feb 2026 |
| CYMBALTA | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | LILLY | Discontinued | 3 Aug 2004 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | MARKSANS PHARMA | Discontinued | 11 Dec 2013 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | SUN PHARM | Discontinued | 11 Dec 2013 |
| DULOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 30MG BASE; EQ 60MG BASE | capsule, delayed rel pellets · oral | TORRENT | Discontinued | 11 Dec 2013 |
4 more — full table
EMA European Union — centrally authorised medicines
Cymbalta Eli Lilly Nederland B.V. · Authorised · authorised 17 Dec 2004 · ATC N06AX21
Therapeutic indication (EMA)
Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Cymbalta is indicated in adults.
Duloxetine Lilly Eli Lilly Nederland B.V. · Authorised · authorised 8 Dec 2014 · ATC N06AX21
Therapeutic indication (EMA)
Duloxetine Lilly is indicated in adults for: Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder Duloxetine Lilly is indicated in adults.
Duloxetine Viatris (previously Duloxetine Mylan) Viatris Limited · Authorised · authorised 19 Jun 2015 · ATC N06AX21
Therapeutic indication (EMA)
Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder Duloxetine Viatris is indicated in adults
Duloxetine Zentiva Zentiva k.s. · Authorised · authorised 20 Aug 2015 · ATC N06AX21
Therapeutic indication (EMA)
Treatment depressive disorder, diabetic neuropathic pain, anxiety disorder. Duloxetine Zentiva is indicated in adults.
Duloxetine Sandoz Sandoz GmbH · Application withdrawn · ATC N06AX21
Therapeutic indication (EMA)
Treatment in adults of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder.
Ariclaim Eli Lilly Nederland B.V. · Withdrawn · authorised 11 Aug 2004 · ATC N06AX21
Therapeutic indication (EMA)
Treatment of diabetic peripheral neuropathic pain. Ariclaim is indicated in adults.
Nodetrip (previously Xeristar) Esteve Pharmaceuticals, S.A. · Withdrawn · authorised 17 Dec 2004 · ATC N06AX21
Therapeutic indication (EMA)
Treatment of major depressive disorder; Treatment of diabetic peripheral neuropathic pain; Treatment of generalised anxiety disorder; Xeristar is indicated in adults.
Duloxetine Boehringer Ingelheim Boehringer Ingelheim International GmbH · Withdrawn · authorised 8 Oct 2008 · ATC N06AX21
Therapeutic indication (EMA)
Treatment of diabetic peripheral neuropathic pain in adults.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ACCEL-DULOXETINE | 02522861 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | ACCEL PHARMA INC |
| ACCEL-DULOXETINE | 02522888 | 60 MG | CAPSULE (DELAYED-RELEASE) · ORAL | ACCEL PHARMA INC |
| AG-DULOXETINE | 02475308 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | ANGITA PHARMA INC. |
| AG-DULOXETINE | 02475316 | 60 MG | CAPSULE (DELAYED-RELEASE) · ORAL | ANGITA PHARMA INC. |
| ALTA-DULOXETINE | 02481952 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | ALTAMED PHARMA |
| ALTA-DULOXETINE | 02481960 | 60 MG | CAPSULE (DELAYED-RELEASE) · ORAL | ALTAMED PHARMA |
| APO-DULOXETINE | 02440423 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | APOTEX INC |
| APO-DULOXETINE | 02440431 | 60 MG | CAPSULE (DELAYED-RELEASE) · ORAL | APOTEX INC |
| AURO-DULOXETINE | 02436647 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | AURO PHARMA INC |
| AURO-DULOXETINE | 02436655 | 60 MG | CAPSULE (DELAYED-RELEASE) · ORAL | AURO PHARMA INC |
| BIO-DULOXETINE | 02507722 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | BIOMED PHARMA |
| BIO-DULOXETINE | 02507765 | 60 MG | CAPSULE (DELAYED-RELEASE) · ORAL | BIOMED PHARMA |
| DULOXETINE | 02453630 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | SIVEM PHARMACEUTICALS ULC |
| DULOXETINE | 02453649 | 60 MG | CAPSULE (DELAYED-RELEASE) · ORAL | SIVEM PHARMACEUTICALS ULC |
| DULOXETINE | 02495082 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | LABORATOIRE RIVA INC. |
| DULOXETINE | 02495090 | 60 MG | CAPSULE (DELAYED-RELEASE) · ORAL | LABORATOIRE RIVA INC. |
| JAMP-DULOXETINE | 02451913 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | JAMP PHARMA CORPORATION |
| JAMP-DULOXETINE | 02451921 | 60 MG | CAPSULE (DELAYED-RELEASE) · ORAL | JAMP PHARMA CORPORATION |
| M-DULOXETINE | 02473208 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | MANTRA PHARMA INC |
| M-DULOXETINE | 02473216 | 60 MG | CAPSULE (DELAYED-RELEASE) · ORAL | MANTRA PHARMA INC |
| MAR-DULOXETINE | 02446081 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-DULOXETINE | 02446103 | 60 MG | CAPSULE (DELAYED-RELEASE) · ORAL | MARCAN PHARMACEUTICALS INC |
| MINT-DULOXETINE | 02438984 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | MINT PHARMACEUTICALS INC |
| MINT-DULOXETINE | 02438992 | 60 MG | CAPSULE (DELAYED-RELEASE) · ORAL | MINT PHARMACEUTICALS INC |
| NRA-DULOXETINE | 02482126 | 30 MG | CAPSULE (DELAYED-RELEASE) · ORAL | NORA PHARMA INC |
11 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DRIZALMA SPRINKLE DR 20 MG CAP | $7.04433 | per EA | 23 Sep 2026 |
| US NADAC | DRIZALMA SPRINKLE DR 30 MG CAP | $7.23088 | per EA | 23 Sep 2026 |
| US NADAC | DRIZALMA SPRINKLE DR 40 MG CAP | $7.16995 | per EA | 23 Sep 2026 |
| US NADAC | DRIZALMA SPRINKLE DR 60 MG CAP | $7.15216 | per EA | 23 Sep 2026 |
| US NADAC | DULOXETINE HCL DR 20 MG CAP | $0.11867 | per EA | 23 Sep 2026 |
| US NADAC | DULOXETINE HCL DR 30 MG CAP | $0.10243 | per EA | 23 Sep 2026 |
| US NADAC | DULOXETINE HCL DR 40 MG CAP | $1.24391 | per EA | 23 Sep 2026 |
| US NADAC | DULOXETINE HCL DR 60 MG CAP | $0.13493 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Duloxetine 120mg gastro-resistant capsules | £49.47 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Duloxetine 20mg gastro-resistant capsules | £2.49 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Duloxetine 30mg gastro-resistant capsules | £1.69 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Duloxetine 40mg gastro-resistant capsules | £2.55 | 56 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Duloxetine 60mg gastro-resistant capsules | £2.36 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Duloxetine 90mg gastro-resistant capsules | £42.27 | 28 capsule | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 18 Aug 2023 CYMBALTA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 18 Aug 2023 DRIZALMA SPRINKLE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 29 Sep 2022 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No - EMA PRAC 10 Mar 2022 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No - EMA PRAC 1 Oct 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: Yes - EMA PRAC 11 Jun 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No - EMA PRAC 12 Mar 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No - EMA PRAC 16 May 2019 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: Yes - EMA PRAC 31 Oct 2018 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: No - EMA PRAC 6 Sep 2018 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: No - EMA PRAC 6 Sep 2018 PRAC signal: Interstitial lung disease
Action for MAH: update of the product information: Yes - EMA PRAC 12 Apr 2018 PRAC signal: Interstitial lung disease
Action for MAH: update of the product information: No - MHRA 11 Dec 2014 Duloxetine: marketed as Cymbalta▼ and Yentreve▼ for different disorders
Patients should be assessed regularly due to reported cases of suicidal ideation and suicidal behaviour during treatment with duloxetine or shortly after stopping treatment. - EMA PRAC 9 Jan 2014 PRAC signal: Vasculitis
Action for MAH: update of the product information: No - EMA PRAC 16 May 2013 PRAC signal: Interaction with linezolid leading to serotonin syndrome
Action for MAH: update of the product information: Yes
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.