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Details for Generic Name: milnacipran hydrochloride

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Milnacipran hydrochloride is the generic ingredient in one branded drug marketed by Cypress Bioscience and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has fourteen patent family members in nine countries.

There are seventeen drug master file entries for milnacipran hydrochloride. Eight suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: milnacipran hydrochloride

Drug Master File Entries: see list17
Suppliers / Packaging: see list27

Pharmacology for Ingredient: milnacipran hydrochloride


Applicant Application No. Form Dosage

Clinical Trials for: milnacipran hydrochloride

The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
Status: Completed Condition: Sleep Disorders; Fibromyalgia; Sleep

Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)
Status: Terminated Condition: Irritable Bowel Syndrome

Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis
Status: Completed Condition: Arthritis, Rheumatoid

Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
Status: Completed Condition: Fibromyalgia

Study to Evaluate the Efficacy of Milnacipran in the Treatment of Pain Due to Osteoarthritis
Status: Recruiting Condition: Osteoarthritis

Milnacipran and Neurocognition, Pain and Fatigue in Fibromyalgia : A 13-week Randomized, Placebo Controlled Cross Over Trial
Status: Completed Condition: Fibromyalgia; Neurocognition

Courtesy of
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
Cypress Bioscience
milnacipran hydrochloride
TABLET; ORAL022256-003Jan 14, 2009RXNo<disabled><disabled>
Cypress Bioscience
milnacipran hydrochloride
TABLET; ORAL022256-001Jan 14, 2009RXNo6,602,911<disabled><disabled>
Cypress Bioscience
milnacipran hydrochloride
TABLET; ORAL022256-002Jan 14, 2009RXNo6,602,911<disabled><disabled>
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International Patent Family for Ingredient: milnacipran hydrochloride

Country Document Number Publication Date
European Patent Office2322225May 18, 2011
MexicoPA05000566Aug 29, 2005
Austria552856Apr 15, 2012
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2015 thinkBiotech LLC
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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