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Levomilnacipran hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for levomilnacipran hydrochloride?

Levomilnacipran hydrochloride is the generic ingredient in one branded drug marketed by Forest Labs Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levomilnacipran hydrochloride has forty-seven patent family members in twenty-six countries.

There are five drug master file entries for levomilnacipran hydrochloride. Two suppliers are listed for this compound.

Summary for Generic Name: levomilnacipran hydrochloride

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packagers: see list2
Bulk Api Vendors: see list22
Clinical Trials: see list991
Patent Applications: see list10
Drug Prices:see low prices
DailyMed Link:levomilnacipran hydrochloride at DailyMed

Pharmacology for Ingredient: levomilnacipran hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-002Jul 25, 2013RXYesNo8,481,598► Subscribe ► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-001Jul 25, 2013RXYesNo8,865,937► SubscribeYY ► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-001Jul 25, 2013RXYesNoRE43879► Subscribe ► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-002Jul 25, 2013RXYesNoRE43879► Subscribe ► Subscribe
Forest Labs Inc
FETZIMA
levomilnacipran hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL204168-002Jul 25, 2013RXYesNo► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: levomilnacipran 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
9,259,403Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide► Subscribe
7,005,452Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug► Subscribe
7,074,833Use of the (1S,2R) 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 Ingredient: levomilnacipran hydrochloride

Country Document Number Estimated Expiration
France2851163► Subscribe
Canada2514948► Subscribe
Norway20054228► Subscribe
European Patent Office2305225► Subscribe
Russian Federation2317817► 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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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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