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Last Updated: April 25, 2024

LEVOMILNACIPRAN HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for levomilnacipran hydrochloride and what is the scope of freedom to operate?

Levomilnacipran hydrochloride is the generic ingredient in two branded drugs marketed by Abbvie, Amneal Pharms Co, Aurobindo Pharma Ltd, Hikma, and Prinston Inc, and is included in five NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Levomilnacipran hydrochloride has fifty-four patent family members in twenty-seven countries.

There are ten drug master file entries for levomilnacipran hydrochloride. Two suppliers are listed for this compound.

Summary for LEVOMILNACIPRAN HYDROCHLORIDE

International Patents:	54
US Patents:	3
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	14
Patent Applications:	102
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVOMILNACIPRAN HYDROCHLORIDE
What excipients (inactive ingredients) are in LEVOMILNACIPRAN HYDROCHLORIDE?	LEVOMILNACIPRAN HYDROCHLORIDE excipients list
DailyMed Link:	LEVOMILNACIPRAN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for LEVOMILNACIPRAN HYDROCHLORIDE

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

Sponsor	Phase
Allergan	Phase 3
University of Ottawa	Phase 4
Allergan	Phase 4

See all LEVOMILNACIPRAN HYDROCHLORIDE clinical trials

Pharmacology for LEVOMILNACIPRAN HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for LEVOMILNACIPRAN HYDROCHLORIDE

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 LEVOMILNACIPRAN HYDROCHLORIDE

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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
Hikma	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210732-002	Nov 5, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210826-002	Jan 6, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal Pharms Co	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210790-001	Feb 4, 2019		DISCN	No	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	204168-002	Jul 25, 2013		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Prinston Inc	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210771-004	Mar 20, 2023	AB	RX	No	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				⤷ 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 LEVOMILNACIPRAN HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
France	2851163	UTILISATION DE L'ENANTIOMERE DEXTROGYRE DU MILNACIPRAN POUR LA PREPARATION D'UN MEDICAMENT	⤷ Try a Trial
Japan	5431136		⤷ Try a Trial
Slovenia	1601349		⤷ Try a Trial
Cyprus	1108287		⤷ Try a Trial
European Patent Office	2496079	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)	⤷ Try a Trial
Canada	2514948	UTILISATION DE L'ENANTIOMERE (1S, 2R) DU MILNACIPRAN POUR LAPREPARATION D'UN MEDICAMENT (USE OF THE ENANTIOMER (1S, 2R) OF MILNACIPRAN FOR THE PREPARATION OF A MEDICAMENT)	⤷ Try a Trial
Spain	2359441		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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