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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 two tentative approvals for this compound.

Summary for Generic Name: milnacipran hydrochloride

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list17
Suppliers / Packaging: see list27

Pharmacology for Ingredient: milnacipran hydrochloride

Tentative approvals for MILNACIPRAN HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL50MG
<disabled><disabled>TABLET;ORAL100MG
<disabled><disabled>TABLET;ORAL12.5MG

Clinical Trials for: milnacipran hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cypress Bioscience
SAVELLA
milnacipran hydrochloride
TABLET; ORAL022256-002Jan 14, 2009RXNo<disabled><disabled>
Cypress Bioscience
SAVELLA
milnacipran hydrochloride
TABLET; ORAL022256-004Jan 14, 2009RXYes6,992,110<disabled><disabled>
Cypress Bioscience
SAVELLA
milnacipran hydrochloride
TABLET; ORAL022256-004Jan 14, 2009RXYes<disabled><disabled>
Cypress Bioscience
SAVELLA
milnacipran hydrochloride
TABLET; ORAL022256-001Jan 14, 2009RXNo6,992,110<disabled><disabled>
Cypress Bioscience
SAVELLA
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
Spain2433080Dec 09, 2013
European Patent Office2322225Jul 31, 2013
China1671368Sep 21, 2005
Austria552856Apr 15, 2012
Portugal1463528Jun 27, 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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