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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-five 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 list35
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 60MG BASE
<disabled><disabled>CAPSULE, DELAYED RELEASE; ORALEQ 20MG BASE
<disabled><disabled>CAPSULE, DELAYED RELEASE; ORALEQ 30MG BASE

Clinical Trials for: duloxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 2004RXNo<disabled><disabled>
Zydus Pharms Usa Inc
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090739-001Jan 8, 2014RXNo<disabled><disabled>
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-002Aug 3, 2004RXNo<disabled><disabled>
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 2004RXNo<disabled><disabled>
Torrent Pharms Ltd
DULOXETINE HYDROCHLORIDE
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL090774-001Dec 11, 2013RXNo<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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