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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fetzima

A generic version of FETZIMA was approved as levomilnacipran hydrochloride by PRINSTON INC on March 20^th, 2023.

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Summary for FETZIMA

International Patents:	54
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	7
Patent Applications:	44
Drug Prices:	Drug price information for FETZIMA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FETZIMA
What excipients (inactive ingredients) are in FETZIMA?	FETZIMA excipients list
DailyMed Link:	FETZIMA at DailyMed

Drug patent expirations by year for FETZIMA

Recent Clinical Trials for FETZIMA

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

Sponsor	Phase
Allergan	Phase 4
University of Ottawa	Phase 4
Weill Cornell Institute of Geriatric Psychiatry	Phase 4

See all FETZIMA clinical trials

Pharmacology for FETZIMA

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

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 and one FDA Regulatory Exclusivity.

Patents protecting FETZIMA

Stable dosage forms of levomilnacipran
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Patent Expiration: ⤷ Sign Up

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

FDA Regulatory Exclusivity protecting FETZIMA

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM STUDY LVM-MD-11 AND LVM-MD-14
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-001	Jul 25, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-003	Jul 25, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-004	Jul 25, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Patent: NOUVELLES FORMES CRISTALLINES DU (1S,2R)-2-(AMINOMETHYL)-N,N-DIETHYL-1-PHENYLCYCLOPROPANECARBOXAMIDE (NOVEL CRYSTALLINE FORMS OF (1S,2R)-2-(AMINO METHYL)-N,N-DIETHYL-1-PHENYL CYCLOPROPANE CARBOXAMIDE)
Estimated Expiration: ⤷ Sign Up

Patent: 90933
Patent: FORMES POSOLOGIQUES STABLES DE LEVOMILNACIPRAN (STABLE DOSAGE FORMS OF LEVOMILNACIPRAN)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 96079
Patent: NOUVELLES FORMES CRISTALLINES DU (1S,2R)-2-(AMINOMÉTHYL)-N,N-DIÉTHYL-1-PHÉNYLCYCLOPROPANECARBOXAMIDE (NOVEL CRYSTALLINE FORMS OF (1S,2R)-2-(AMINO METHYL)-N,N-DIETHYL-1-PHENYL CYCLOPROPANE CARBOXAMIDE)
Estimated Expiration: ⤷ Sign Up

Patent: 36688
Patent: FORMES POSOLOGIQUES STABLES DE LEVOMILNACIPRAN (STABLE DOSAGE FORMS OF LEVOMILNACIPRAN)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 13510176
Estimated Expiration: ⤷ Sign Up

Patent: 13517290
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Austria	501716		⤷ Sign Up
Poland	378057	Zastosowanie enancjomerów (1S, 2R) milnacypranu do wytwarzania leku (USE OF THE ENANTIOMER (1S, 2R) OF MILNACIPRAN FOR THE PREPARATION OF A MEDICAMENT)	⤷ Sign Up
New Zealand	575218	Use of the enantiomer (1S,2R) of milnacipran for the preparation of a medicament	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2011088331		⤷ Sign Up
Japan	2013510176		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2011057176		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration