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Serving leading biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
Deloitte
Accenture
Chubb
McKesson
Cerilliant
Baxter
Merck
Cipla

Generated: November 22, 2017

DrugPatentWatch Database Preview

FETZIMA Drug Profile

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Which patents cover Fetzima, and when can generic versions of Fetzima launch?

Fetzima is a drug marketed by Forest Labs Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in twenty-seven countries.

The generic ingredient in FETZIMA is levomilnacipran hydrochloride. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran 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
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-001Jul 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-002Jul 25, 2013RXYesNo► Subscribe► SubscribeYY ► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-001Jul 25, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-003Jul 25, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-002Jul 25, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-004Jul 25, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-004Jul 25, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-001Jul 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-001Jul 25, 2013RXYesNo► Subscribe► SubscribeYY ► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-002Jul 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
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Paragraph IV (Patent) Challenges for FETZIMA

Drugname Dosage Strength RLD Submissiondate
levomilnacipranExtended-release Capsules20 mg, 40 mg, 80 mg and 120 mgFetzima7/25/2017

Non-Orange Book Patents for Tradename: FETZIMA

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
9,259,403Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide► Subscribe
7,074,833Use of the (1S,2R) enantiomer of milnacipran for the preparation of a drug► Subscribe
7,005,452Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug► 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: FETZIMA

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2011057176► Subscribe
South Africa200506566► Subscribe
Spain2310715► Subscribe
European Patent Office2305225► Subscribe
Japan4515446► Subscribe
Japan2013517290► Subscribe
Hong Kong1115329► Subscribe
Poland402987► Subscribe
Spain2359441► Subscribe
European Patent Office2536688► 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:

McKesson
Federal Trade Commission
Teva
Merck
QuintilesIMS
Covington
Farmers Insurance
Healthtrust
Cipla
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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