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Last Updated: April 22, 2024

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 Abbvie 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.

Drug patent expirations by year for FETZIMA
Drug Prices for FETZIMA

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Recent Clinical Trials for FETZIMA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of OttawaPhase 4
AllerganPhase 4
University of PittsburghPhase 4

See all FETZIMA clinical trials

Paragraph IV (Patent) Challenges for FETZIMA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FETZIMA Extended-release Capsules levomilnacipran hydrochloride 20 mg, 40 mg, 80 mg and 120 mg 204168 6 2017-07-25

US Patents and Regulatory Information for FETZIMA

FETZIMA is protected by three US patents.

Patents protecting FETZIMA

Stable dosage forms of levomilnacipran
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

When does loss-of-exclusivity occur for FETZIMA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Patent: 79711
Estimated Expiration: ⤷  Try a Trial

Patent: 90933
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 96079
Estimated Expiration: ⤷  Try a Trial

Patent: 36688
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 13510176
Estimated Expiration: ⤷  Try a Trial

Patent: 13517290
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FETZIMA around the world.

Country Patent Number Title Estimated Expiration
Ukraine 84697 ИСПОЛЬЗОВАНИЕ (1S,2R) ЭНАНТИОМЕРА МИЛНАЦИПРАНА ДЛЯ ПОЛУЧЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА;ЗАСТОСУВАННЯ (1S,2R) ЕНАНТІОМЕРА МІЛНАЦИПРАНУ ДЛЯ ОДЕРЖАННЯ ЛІКАРСЬКОГО ЗАСОБУ (USE OF THE ENANTIOMER (1S, 2R) OF MILNACIPRAN FOR THE PREPARATION OF A MEDICAMENT) ⤷  Try a Trial
Spain 2310715 ⤷  Try a Trial
Brazil PI0407256 Utilização do enantiÈmero (1s,2r) do milnacipran para a preparação de um medicamento ⤷  Try a Trial
Tunisia SN05195 UTILISATION DE L'ENANTIOMERE (1S,2R) DU MILNACIPRAN POUR LA PREPARATION D'UN MEDICAMENT ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.