LEVOMILNACIPRAN HYDROCHLORIDE Drug Patent Profile

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Which patents cover Levomilnacipran Hydrochloride, and when can generic versions of Levomilnacipran Hydrochloride launch?

Levomilnacipran Hydrochloride is a drug marketed by Amneal Pharms Co, Aurobindo Pharma Ltd, Hikma, and Prinston Inc. and is included in four NDAs.

The generic ingredient in LEVOMILNACIPRAN HYDROCHLORIDE 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 Levomilnacipran Hydrochloride

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

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Summary for LEVOMILNACIPRAN HYDROCHLORIDE

US Patents:	0
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	14
Patent Applications:	44
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVOMILNACIPRAN HYDROCHLORIDE
DailyMed Link:	LEVOMILNACIPRAN HYDROCHLORIDE at DailyMed

Drug patent expirations by year for LEVOMILNACIPRAN HYDROCHLORIDE

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

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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
Amneal Pharms Co	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210790-001	Feb 4, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210826-003	Jan 6, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Co	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210790-004	Feb 4, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210732-004	Nov 5, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210826-004	Jan 6, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210771-004	Mar 20, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	LEVOMILNACIPRAN HYDROCHLORIDE	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210771-002	Mar 20, 2023	AB	RX	No	No	⤷ 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