You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Express Scripts
Harvard Business School
Mallinckrodt
Merck

Last Updated: July 2, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021427


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 021427 describes CYMBALTA, which is a drug marketed by Lilly and is included in one NDA. It is available from three 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-two drug master file entries for this compound. Forty-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
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 0002-3235-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3235-60)
CYMBALTA duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427 NDA Eli Lilly and Company 0002-3240 0002-3240-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3240-30)
Paragraph IV (Patent) Challenges for 021427
Tradename Dosage Ingredient NDA Submissiondate
CYMBALTA CAPSULE, DELAYED REL PELLETS;ORAL duloxetine hydrochloride 021427 2012-05-10
CYMBALTA CAPSULE, DELAYED REL PELLETS;ORAL duloxetine hydrochloride 021427 2008-08-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Aug 3, 2004TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Apr 20, 2023
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:  Start TrialPatent Expiration:Mar 10, 2020Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 30MG BASE
Approval Date:Aug 3, 2004TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Apr 20, 2023
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Boehringer Ingelheim
Baxter
Mallinckrodt
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.