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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Federal Trade Commission
Cipla
Cantor Fitzgerald
Daiichi Sankyo
Express Scripts
US Army
Citi
Dow
US Department of Justice

Generated: December 14, 2017

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Milnacipran hydrochloride - Generic Drug Details

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What are the generic sources for milnacipran hydrochloride and what is the scope of milnacipran hydrochloride freedom to operate?

Milnacipran hydrochloride
is the generic ingredient in two branded drugs marketed by Amneal Pharms, Windlas Hlthcare, and Allergan Sales Llc, and is included in three NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Milnacipran hydrochloride has forty-five patent family members in twenty-five countries.

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

Pharmacology for milnacipran hydrochloride

Tentative approvals for MILNACIPRAN HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe12.5MGTABLET;ORAL
u► Subscribe100MGTABLET;ORAL
u► Subscribe50MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Allergan Sales LlcSAVELLAmilnacipran hydrochlorideTABLET;ORAL022256-001Jan 14, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Allergan Sales LlcSAVELLAmilnacipran hydrochlorideTABLET;ORAL022256-003Jan 14, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Allergan Sales LlcSAVELLAmilnacipran hydrochlorideTABLET;ORAL022256-003Jan 14, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Allergan Sales LlcSAVELLAmilnacipran hydrochlorideTABLET;ORAL022256-002Jan 14, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Allergan Sales LlcSAVELLAmilnacipran hydrochlorideTABLET;ORAL022256-003Jan 14, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Amneal PharmsMILNACIPRAN HYDROCHLORIDEmilnacipran hydrochlorideTABLET;ORAL205081-003Apr 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Amneal PharmsMILNACIPRAN HYDROCHLORIDEmilnacipran hydrochlorideTABLET;ORAL205081-004Apr 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Allergan Sales LlcSAVELLAmilnacipran hydrochlorideTABLET;ORAL022256-003Jan 14, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Windlas HlthcareMILNACIPRAN HYDROCHLORIDEmilnacipran hydrochlorideTABLET;ORAL205071-004Jan 27, 2016DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Allergan Sales LlcSAVELLAmilnacipran hydrochlorideTABLET;ORAL022256-004Jan 14, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: milnacipran hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,635,675 Method of treating chronic fatigue syndrome► Subscribe
7,915,246Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain► Subscribe
7,820,643Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: milnacipran hydrochloride

Country Document Number Estimated Expiration
Malaysia145340► Subscribe
Norway20081951► Subscribe
Canada2624018► Subscribe
Portugal2322225► Subscribe
World Intellectual Property Organization (WIPO)03039598► Subscribe
New Zealand567271► Subscribe
Georgia, Republic ofP20125595► Subscribe
World Intellectual Property Organization (WIPO)2007038620► Subscribe
Spain2395462► Subscribe
China101355930► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Novartis
Medtronic
AstraZeneca
QuintilesIMS
Dow
Merck
Fuji
Julphar
Healthtrust
Queensland Health

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 verifification 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.

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