OLANZAPINE; SAMIDORPHAN L-MALATE - Generic Drug Details

What are the generic sources for olanzapine; samidorphan l-malate and what is the scope of freedom to operate?

Olanzapine; samidorphan l-malate is the generic ingredient in one branded drug marketed by Alkermes Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olanzapine; samidorphan l-malate has eighty-two patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for OLANZAPINE; SAMIDORPHAN L-MALATE

International Patents:	82
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	OLANZAPINE; SAMIDORPHAN L-MALATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OLANZAPINE; SAMIDORPHAN L-MALATE

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 OLANZAPINE; SAMIDORPHAN L-MALATE

Drug Class	Atypical Antipsychotic Opioid Antagonist
Mechanism of Action	Opioid Antagonists

US Patents and Regulatory Information for OLANZAPINE; SAMIDORPHAN L-MALATE

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	213378-003	May 28, 2021		RX	Yes	No
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021		RX	Yes	No
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021		RX	Yes	No
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021		RX	Yes	Yes			Y
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021		RX	Yes	Yes
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021		RX	Yes	Yes
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No				Y

Expired US Patents for OLANZAPINE; SAMIDORPHAN L-MALATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021

International Patents for OLANZAPINE; SAMIDORPHAN L-MALATE

Country	Patent Number	Title	Estimated Expiration
Poland	2251330
Spain	2387737
Australia	2005304950	4-Hydroxybenzomorphans
Japan	2016020364	４−ヒドロキシベンゾモルファン (4-HYDROXYBENZOMORPHANS)
Russian Federation	2007120759	4-ГИДРОКСИБЕНЗОМОРФАНЫ
European Patent Office	2506712	DÉRIVÉS DE MORPHINANE POUR LE TRAITEMENT D'UNE SURDOSE DE DROGUES (MORPHINAN DERIVATIVES FOR THE TREATMENT OF DRUG OVERDOSE)
Canada	2587074	4-HYDROXYBENZOMORPHANES (4-HYDROXYBENZOMORPHANS)

Supplementary Protection Certificates for OLANZAPINE; SAMIDORPHAN L-MALATE

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