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Profile for Tradename: CYMBALTA

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Cymbalta is a drug marketed by Lilly and is included in one NDA. It is available from eighteen suppliers. There are two patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in CYMBALTA is duloxetine hydrochloride. There are thirty-four drug master file entries for this compound. Eighteen suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the duloxetine hydrochloride profile page.

Summary for Tradename: CYMBALTA

Patents:2
Applicants:1
NDAs:1
Suppliers: see list18
2013 Sales:$5,219,860,000

Clinical Trials for: CYMBALTA

The Cymbalta Pregnancy Registry
Status: Recruiting Condition: Pregnancy

Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus Erythematosus
Status: Completed Condition: Systemic Lupus Erythematosus

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

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

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

Bioavailability Study of Duloxetine Delayed-Relase Capsules 60 mg Under Fed Condition
Status: Completed Condition: Healthy

Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition
Status: Completed Condition: Healthy

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

Cymbalta for Fibromyalgia Pain
Status: Recruiting Condition: Fibromyalgia

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
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;ORAL021427-002Aug 3, 2004RXNo<disabled><disabled>
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-002Aug 3, 2004RXNo5,508,276*PED<disabled>Y<disabled>
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 2004RXNo<disabled><disabled>
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-004Aug 3, 2004RXYes<disabled><disabled>
Lilly
CYMBALTA
duloxetine hydrochloride
CAPSULE, DELAYED REL PELLETS;ORAL021427-001Aug 3, 2004RXNo<disabled><disabled>
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Paragraph IV activity for: CYMBALTA

Drugname Dosage Strength RLD Submissiondate
duloxetine hydrochlorideDelayed-release Capsules40 mgCymbalta5/10/2012
duloxetine hydrochlorideDelayed-release Capsules20 mg, 30 mg and 60 mgCymbalta8/4/2008
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Preferred citation:

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

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