Details for New Drug Application (NDA): 213378

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NDA 213378 describes LYBALVI, which is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the LYBALVI profile page.

The generic ingredient in LYBALVI is olanzapine; samidorphan l-malate. There are thirty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olanzapine; samidorphan l-malate profile page.

Summary for 213378

Tradename:	LYBALVI
Applicant:	Alkermes Inc
Ingredient:	olanzapine; samidorphan l-malate
Patents:	13

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 213378

Generic Entry Date for 213378^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 213378

Mechanism of Action	Opioid Antagonists

Suppliers and Packaging for NDA: 213378

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378	NDA	Alkermes, Inc.	65757-651	65757-651-40	1 BOTTLE in 1 CARTON (65757-651-40) / 7 TABLET, FILM COATED in 1 BOTTLE
LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378	NDA	Alkermes, Inc.	65757-651	65757-651-41	1 BOTTLE in 1 CARTON (65757-651-41) / 7 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG;EQ 10MG BASE
Approval Date:	May 28, 2021	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 28, 2026
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	⤷ Sign Up	Patent Expiration:	Aug 23, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
Patent:	⤷ Sign Up	Patent Expiration:	Aug 23, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN

Expired US Patents for NDA 213378

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021	⤷ Sign Up	⤷ Sign Up
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021	⤷ Sign Up	⤷ Sign Up
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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