List of Lybalvi drug patents

Lybalvi is owned by Alkermes Inc.

Lybalvi contains Olanzapine; Samidorphan L-Malate.

Lybalvi has a total of 10 drug patents out of which 0 drug patents have expired.

Lybalvi was authorised for market use on 28 May, 2021.

Lybalvi is available in tablet;oral dosage forms.

Lybalvi can be used as method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain; method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain, method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain, method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan; method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduction of the adverse metabolic profile; method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduction of the adverse metabolic profile, method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan.

Drug patent challenges can be filed against Lybalvi from 2025-05-28.

The generics of Lybalvi are possible to be released after 13 February, 2032.

Patent Number Company Patent Title Patent Expiry Activity Alert
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7262298 ALKERMES INC 4-hydroxybenzomorphans
Nov, 2025

(2 years from now)

US9119848 ALKERMES INC Morphinan derivatives for the treatment of drug overdose
Aug, 2031

(8 years from now)

These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11185541 ALKERMES INC Methods for treating antipsychotic-induced weight gain
Aug, 2031

(8 years from now)

US9126977 ALKERMES INC Methods for treating antipsychotic-induced weight gain
Aug, 2031

(8 years from now)

US9517235 ALKERMES INC Methods for treating antipsychotic-induced weight gain
Aug, 2031

(8 years from now)

US10716785 ALKERMES INC Methods for treating antipsychotic-induced weight gain
Aug, 2031

(8 years from now)

US10300054 ALKERMES INC Methods for treating antipsychotic-induced weight gain
Aug, 2031

(8 years from now)

US11351166 ALKERMES INC Methods for treating antipsychotic-induced weight gain
Aug, 2031

(8 years from now)

US11241425 ALKERMES INC Composition for treating mental illness
Aug, 2031

(8 years from now)

US8778960 ALKERMES INC Methods for treating antipsychotic-induced weight gain
Feb, 2032

(8 years from now)

Exclusivity Exclusivity Expiration
New Chemical Entity Exclusivity (NCE) May 28, 2026

Drugs and Companies using OLANZAPINE; SAMIDORPHAN L-MALATE ingredient

NCE-1 date: 2025-05-28

Market Authorisation Date: 28 May, 2021

Treatment: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan; Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and sam...

Dosage: TABLET;ORAL

More Information on Dosage

LYBALVI family patents

26

United States

6

Australia

6

Japan

6

European Union

3

Denmark

3

Slovenia

3

Portugal

3

Spain

3

Poland

3

Canada

2

Turkey

2

Russia

2

Lithuania

2

Hungary

2

Croatia

2

Cyprus

2

RS

2

New Zealand

1

Israel

1

Austria

1

Mexico

1

Norway

1

Brazil

1

Korea, Republic of

1

China

1

ME

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