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Last Updated: November 23, 2020

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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 Allergan 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 eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Fetzima

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for FETZIMA
Drug Prices for FETZIMA

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Recent Clinical Trials for FETZIMA

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SponsorPhase
AllerganPhase 4
University of OttawaPhase 4
University of California, Los AngelesPhase 3

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Paragraph IV (Patent) Challenges for FETZIMA
Tradename Dosage Ingredient NDA Submissiondate
FETZIMA CAPSULE, EXTENDED RELEASE;ORAL levomilnacipran hydrochloride 204168 2017-07-25

US Patents and Regulatory Information for FETZIMA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-001 Jul 25, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-002 Jul 25, 2013 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-001 Jul 25, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
AstraZeneca
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Medtronic
Harvard Business School

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