Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Cipla
Deloitte
Cerilliant
Accenture
US Department of Justice
Teva
Argus Health
Julphar
Federal Trade Commission

Generated: October 20, 2017

DrugPatentWatch Database Preview

Milnacipran hydrochloride - Generic Drug Details

« Back to Dashboard

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 Allergan Sales Llc, Windlas Hlthcare, and Amneal Pharms, 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.

Summary for Generic Name: milnacipran hydrochloride

US Patents:4
Tradenames:2
Applicants:3
NDAs:3
Drug Master File Entries: see list26
Suppliers / Packagers: see list8
Bulk Api Vendors: see list68
Clinical Trials: see list2,332
Patent Applications: see list393
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:milnacipran hydrochloride at DailyMed

Pharmacology for Ingredient: 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 Product Substance Delist Req. Exclusivity Expiration
Allergan Sales Llc
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-004Jan 14, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Allergan Sales Llc
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-003Jan 14, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Allergan Sales Llc
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-002Jan 14, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Allergan Sales Llc
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-003Jan 14, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Allergan Sales Llc
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-001Jan 14, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Allergan Sales Llc
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-001Jan 14, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Allergan Sales Llc
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-003Jan 14, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Windlas Hlthcare
MILNACIPRAN HYDROCHLORIDE
milnacipran hydrochloride
TABLET;ORAL205071-002Jan 27, 2016DISCNNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
MILNACIPRAN HYDROCHLORIDE
milnacipran hydrochloride
TABLET;ORAL205081-003Apr 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
MILNACIPRAN HYDROCHLORIDE
milnacipran hydrochloride
TABLET;ORAL205081-002Apr 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: milnacipran hydrochloride

Country Document Number Estimated Expiration
MexicoPA05000566► Subscribe
New Zealand593199► Subscribe
European Patent Office1463528► Subscribe
Georgia, Republic ofP20125595► Subscribe
Singapore183735► Subscribe
Norway20081951► Subscribe
Austria552856► Subscribe
South Africa200803469► Subscribe
China101355930► Subscribe
European Patent Office1545489► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Moodys
UBS
AstraZeneca
Johnson and Johnson
QuintilesIMS
Merck
Daiichi Sankyo
Farmers Insurance
Harvard Business School
Fish and Richardson

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot