levomilnacipran hydrochloride - Profile

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.

Summary for levomilnacipran hydrochloride

International Patents:	54
US Patents:	3
Tradenames:	2
Applicants:	5
NDAs:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for levomilnacipran hydrochloride

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	204168-001	Jul 25, 2013	AB	RX	Yes	No	8,481,598
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-001	Jul 25, 2013	AB	RX	Yes	No	RE43879
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-001	Jul 25, 2013	AB	RX	Yes	No	8,865,937		Y	Y
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-001	Jul 25, 2013	AB	RX	Yes	No

Expired US Patents for levomilnacipran hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-003	Jul 25, 2013	RE43879
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-001	Jul 25, 2013	RE43879
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-004	Jul 25, 2013	RE43879
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013	RE43879

International Patents for levomilnacipran hydrochloride

Country	Patent Number	Title	Estimated Expiration
Canada	2779711	NOUVELLES FORMES CRISTALLINES DU (1S,2R)-2-(AMINOMETHYL)-N,N-DIETHYL-1-PHENYLCYCLOPROPANECARBOXAMIDE (NOVEL CRYSTALLINE FORMS OF (1S,2R)-2-(AMINO METHYL)-N,N-DIETHYL-1-PHENYL CYCLOPROPANE CARBOXAMIDE)
Canada	2790933	FORMES POSOLOGIQUES STABLES DE LEVOMILNACIPRAN (STABLE DOSAGE FORMS OF LEVOMILNACIPRAN)
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)
European Patent Office	2536688	FORMES POSOLOGIQUES STABLES DE LEVOMILNACIPRAN (STABLE DOSAGE FORMS OF LEVOMILNACIPRAN)