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Citi
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Express Scripts
Colorcon
US Army
Mallinckrodt

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021427

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NDA 021427 describes CYMBALTA, which is a drug marketed by Lilly and is included in one NDA. It is available from twelve suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the CYMBALTA profile page.

The generic ingredient in CYMBALTA is duloxetine hydrochloride. There are forty-one drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 021427
Tradename:CYMBALTA
Applicant:Lilly
Ingredient:duloxetine hydrochloride
Patents:1
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 021427
Suppliers and Packaging for NDA: 021427
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427 NDA Eli Lilly and Company 0002-3235 N 0002-3235-60
CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427 NDA Eli Lilly and Company 0002-3240 N 0002-3240-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Aug 3, 2004TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 10, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 30MG BASE
Approval Date:Aug 3, 2004TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 10, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 60MG BASE
Approval Date:Aug 3, 2004TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 10, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021427

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-002 Aug 3, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-004 Aug 3, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427-001 Aug 3, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Colorcon
Accenture
Moodys
McKinsey
Deloitte
Boehringer Ingelheim
QuintilesIMS
US Department of Justice

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