FETZIMA Drug Patent Profile

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^® Litigation and Generic Entry Outlook for Fetzima

A generic version of FETZIMA was approved as levomilnacipran hydrochloride by AUROBINDO PHARMA LTD on January 6^th, 2023.

Summary for FETZIMA

International Patents:	54
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	7
Patent Applications:	55
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

See drug prices for FETZIMA

Recent Clinical Trials for FETZIMA

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

Sponsor	Phase
University of Ottawa	Phase 4
Allergan	Phase 4
University of Pittsburgh	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

Anatomical Therapeutic Chemical (ATC) Classes for FETZIMA

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

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

FDA Regulatory Exclusivity protecting 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	AB	RX	Yes	No
Allergan	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013	AB	RX	Yes	No			Y	Y
Allergan	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-001	Jul 25, 2013	AB	RX	Yes	No

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

European Patent Office

Japan

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
Austria	401872
Spain	2310715
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)