Levomilnacipran hydrochloride - Generic Drug Details

What are the generic drug 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:	88
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

Anatomical Therapeutic Chemical (ATC) Classes for levomilnacipran hydrochloride

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 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

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	204168-002	Jul 25, 2013		RX	Yes	No
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-003	Jul 25, 2013		RX	Yes	No	8,481,598
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013		RX	Yes	No	8,865,937		Y	Y
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013		RX	Yes	No	8,481,598
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-003	Jul 25, 2013		RX	Yes	No	RE43879
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013		RX	Yes	No	RE43879
Hikma	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210732-003	Nov 5, 2020		DISCN	No	No

International Patents for levomilnacipran hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2013510176
Japan	2013517290
Japan	2010090143	USE OF ENANTIOMER (1S,2R) OF MILNACIPRAN FOR PREPARATION OF MEDICAMENT
European Patent Office	2536688	FORMES POSOLOGIQUES STABLES DE LEVOMILNACIPRAN (STABLE DOSAGE FORMS OF LEVOMILNACIPRAN)
World Intellectual Property Organization (WIPO)	2011057176
Poland	219671
Brazil	PI0407256	Utilização do enantiÈmero (1s,2r) do milnacipran para a preparação de um medicamento