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Last Updated: January 28, 2022

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FETZIMA Drug Patent 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.

DrugPatentWatch® Generic Entry Outlook for Fetzima

There have been nine 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
University of OttawaPhase 4
AllerganPhase 4
National Institute of Mental Health (NIMH)Phase 4

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Anatomical Therapeutic Chemical (ATC) Classes for FETZIMA
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

FETZIMA is protected by three US patents and one FDA Regulatory Exclusivity.

Patents protecting FETZIMA

Stable dosage forms of levomilnacipran
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial
Patented Use: TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial

Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial
Patented Use: TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

FDA Regulatory Exclusivity protecting FETZIMA

INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY LVM-MD-15 TO FULFILL POSTMARKETING COMMITMENT 1943-4
Exclusivity Expiration: ⤷  Sign up for a Free Trial

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 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-002 Jul 25, 2013 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y Y ⤷  Sign up for a Free Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-001 Jul 25, 2013 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-003 Jul 25, 2013 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-002 Jul 25, 2013 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-004 Jul 25, 2013 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Allergan FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-004 Jul 25, 2013 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for FETZIMA

Country Patent Number Estimated Expiration
Ukraine 84697 ⤷  Sign up for a Free Trial
Hong Kong 1115329 ⤷  Sign up for a Free Trial
World Intellectual Property Organization (WIPO) 2004075886 ⤷  Sign up for a Free Trial
Germany 602004031893 ⤷  Sign up for a Free Trial
Spain 2359441 ⤷  Sign up for a Free Trial
Denmark 1601349 ⤷  Sign up for a Free Trial
Slovenia 1908461 ⤷  Sign up for a Free Trial
>Country >Patent Number >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
AstraZeneca
Express Scripts
Medtronic
Harvard Business School

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