LYBALVI Drug Patent Profile

When do Lybalvi patents expire, and when can generic versions of Lybalvi launch?

Lybalvi is a drug marketed by Alkermes Inc and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.

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

DrugPatentWatch^® Generic Entry Outlook for Lybalvi

Lybalvi was eligible for patent challenges on May 28, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 12, 2041. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for LYBALVI

US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	1
Drug Prices:	Drug price information for LYBALVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LYBALVI
What excipients (inactive ingredients) are in LYBALVI?	LYBALVI excipients list
DailyMed Link:	LYBALVI at DailyMed

See drug prices for LYBALVI

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

Constraining patent/regulatory exclusivity:

11,707,466

NDA:

213378

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.

Recent Clinical Trials for LYBALVI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Alkermes, Inc.	Phase 1

See all LYBALVI clinical trials

Pharmacology for LYBALVI

Drug Class	Atypical Antipsychotic Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Paragraph IV (Patent) Challenges for LYBALVI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LYBALVI	Tablets	olanzapine; samidorphan l-malate	5 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg	213378	3	2025-05-28

US Patents and Regulatory Information for LYBALVI

LYBALVI is protected by twenty-one US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,707,466.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021		RX	Yes	No	11,707,466		Y
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021		RX	Yes	No	9,119,848			Y
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No	11,351,166
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No	11,241,425
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No	9,126,977		Y
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No	11,951,111
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021		RX	Yes	No	9,126,977		Y

Expired US Patents for LYBALVI

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	7,262,298
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021	7,956,187
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021	7,262,298
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021	8,252,929
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021	7,956,187
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021	7,262,298
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021	7,956,187

International Patents for LYBALVI

When does loss-of-exclusivity occur for LYBALVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LYBALVI around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2011293502
Australia	2015201907
Australia	2017200396
Australia	2018202410
Canada	2807965
Cyprus	1121128
Denmark	2608670

Supplementary Protection Certificates for LYBALVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454436	97C0012	Belgium		PRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927

DrugChatter Q&A for LYBALVI

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Does lybalvi cause significant weight gain?