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Serving leading biopharmaceutical companies globally:

Cerilliant
Merck
Chinese Patent Office
Accenture
Fish and Richardson
UBS
Novartis
Deloitte
Harvard Business School
Chubb

Generated: November 20, 2017

DrugPatentWatch Database Preview

SAVELLA Drug Profile

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What is the patent landscape for Savella, and when can generic versions of Savella launch?

Savella is a drug marketed by Allergan Sales Llc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-five patent family members in twenty-five countries.

The generic ingredient in SAVELLA is milnacipran hydrochloride. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.
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;ORAL022256-001Jan 14, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Allergan Sales Llc
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-002Jan 14, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Allergan Sales Llc
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-001Jan 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;ORAL022256-004Jan 14, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Allergan Sales Llc
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-004Jan 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;ORAL022256-001Jan 14, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Allergan Sales Llc
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-002Jan 14, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
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Paragraph IV (Patent) Challenges for SAVELLA

Drugname Dosage Strength RLD Submissiondate
milnacipran hydrochlorideTablets12.5 mg, 25 mg, 50 mg, and 100 mgSavella1/14/2013

Non-Orange Book Patents for Tradename: SAVELLA

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 Tradename: SAVELLA

Country Document Number Estimated Expiration
Australia2006294645► Subscribe
Canada2493490► Subscribe
MexicoPA05000566► Subscribe
New Zealand567271► Subscribe
Canada2467356► Subscribe
El Salvador2008002855► Subscribe
Japan2012193216► Subscribe
World Intellectual Property Organization (WIPO)2007038620► Subscribe
World Intellectual Property Organization (WIPO)03053426► Subscribe
Portugal2322225► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Moodys
Chubb
UBS
QuintilesIMS
Queensland Health
Covington
AstraZeneca
Harvard Business School
Fuji
Cerilliant

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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