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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, Apotex Inc, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Lupin Ltd, Sun Pharma Global, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in thirteen 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

Tradenames:2
Patents:2
Applicants:12
NDAs:13
Drug Master File Entries: see list36
Suppliers / Packaging: see list66
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for Ingredient: duloxetine hydrochloride

Tentative approvals for DULOXETINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, DELAYED RELEASE; ORALEQ 20MG BASE
<disabled><disabled>CAPSULE, DELAYED RELEASE; ORALEQ 30MG BASE
<disabled><disabled>CAPSULE, DELAYED RELEASE; ORALEQ 60MG BASE

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 ClinicalTrials.org
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
Zydus Pharms Usa Inc
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090728-002Jan 8, 2014RXNo<disabled><disabled>
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-002Aug 3, 2004RXNo5,508,276*PED<disabled>Y<disabled>
Breckenridge Pharm
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL203088-001Jun 11, 2014RXNo<disabled><disabled>
Torrent Pharms Ltd
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090774-002Dec 11, 2013RXNo<disabled><disabled>
Zydus Pharms Usa Inc
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090739-001Jan 8, 2014RXNo<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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