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Details for Generic Name: duloxetine hydrochloride

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Duloxetine hydrochloride is the generic ingredient in two branded drugs marketed by Lilly, Actavis Elizabeth, Alembic Pharms Ltd, Alkem Labs Ltd, Anchen Pharms, Apotex Inc, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Inventia Hlthcare, Lupin Ltd, Sun Pharma Global, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in sixteen NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for duloxetine hydrochloride. Eighteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: duloxetine hydrochloride

Drug Master File Entries: see list36
Suppliers / Packaging: see list66
Therapeutic Class:Antidepressants

Pharmacology for Ingredient: duloxetine hydrochloride

Tentative approvals for DULOXETINE HYDROCHLORIDE

Applicant Application No. Form Dosage

Clinical Trials for: duloxetine hydrochloride

A Study for the Treatment of Diabetic Peripheral Neuropathic Pain
Status: Completed Condition: Diabetic Neuropathies

An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain
Status: Completed Condition: Diabetic Neuropathy, Painful

Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury
Status: Terminated Condition: Traumatic Brain Injury; Depression

A Study to Evaluate the Pharmacokinetics of Duloxetine in Chinese Han Healthy Subjects
Status: Completed Condition: Healthy

Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome
Status: Completed Condition: Anxiety Disorder

The Cymbalta Pregnancy Registry
Status: Recruiting Condition: Pregnancy

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090745-002Dec 11, 2013RXNo<disabled><disabled>
Alembic Pharms Ltd
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL202949-003Jun 9, 2014RXNo<disabled><disabled>
Anchen Pharms
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090780-001Oct 28, 2015RXNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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