LEVOMILNACIPRAN HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for levomilnacipran hydrochloride and what is the scope of patent protection?

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
Allergan	Phase 4
University of Ottawa	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

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	204168-004	Jul 25, 2013		RX	Yes	Yes			Y	Y
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-003	Jul 25, 2013		RX	Yes	No			Y	Y
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013		RX	Yes	No
Amneal Pharms Co	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210790-002	Feb 4, 2019		DISCN	No	No
Aurobindo Pharma Ltd	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210826-002	Jan 6, 2023		DISCN	No	No
Amneal Pharms Co	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210790-003	Feb 4, 2019		DISCN	No	No
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
New Zealand	541733	Use of the enantiomer (1S,2R) of milnacipran for the preparation of a medicament
Japan	2013517290
Morocco	27655	UTILISATION DE L'ENANTIOMERE (1S,2R) DU MILNACIPRAN POUR LA PREPARATION D'UN MEDICAMENT
Austria	401872
World Intellectual Property Organization (WIPO)	2011057176
Brazil	PI0407256	Utilização do enantiÈmero (1s,2r) do milnacipran para a preparação de um medicamento
Hong Kong	1115329	USE OF (1S, 2R) ENANTIOMER OF MILNACIPRAN FOR THE PREPARATION OF A MEDICINE