Lybalvi Patent Expiration

Lybalvi is a drug owned by Alkermes Inc. It is protected by 15 US drug patents filed from 2021 to 2024. Out of these, 13 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 12, 2041. Details of Lybalvi's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8252929 8-carboxamido-2,6-methano-3-benzazocines
Oct, 2021

(2 years ago)

Expired
US7956187 Method for decreasing opioid metabolism
Oct, 2021

(2 years ago)

Expired
US7262298 4-hydroxybenzomorphans
Nov, 2025

(1 year, 4 months from now)

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

(7 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11793805 Methods for treating antipsychotic-induced weight gain
Aug, 2031

(7 years from now)

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

(7 years from now)

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

(7 years from now)

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

(7 years from now)

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

(7 years from now)

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

(7 years from now)

Active
US11241425 Composition for treating mental illness
Aug, 2031

(7 years from now)

Active
US11185541 Methods for treating antipsychotic-induced weight gain
Aug, 2031

(7 years from now)

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

(7 years from now)

Active
US11707466 Immediate release multilayer tablet
Nov, 2041

(17 years from now)

Active
US11951111 Immediate release multilayer tablet
Nov, 2041

(17 years from now)

Active


FDA has granted several exclusivities to Lybalvi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lybalvi, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Lybalvi.

Exclusivity Information

Lybalvi holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Lybalvi's exclusivity codes and their expiration dates are given below.


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

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US patents provide insights into the exclusivity only within the United States, but Lybalvi is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Lybalvi's family patents as well as insights into ongoing legal events on those patents.

Lybalvi's family patents

Lybalvi has patent protection in a total of 26 countries. It's US patent count contributes only to 30.2% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Lybalvi.

Family Patents

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Generic Launch

Generic Release Date:

Lybalvi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 12, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Lybalvi Generics:

There are no approved generic versions for Lybalvi as of now.





About Lybalvi

Lybalvi is a drug owned by Alkermes Inc. It is used for treating bipolar disorder and schizophrenia with reduced weight gain and adverse metabolic effects by combining olanzapine and samidorphan. Lybalvi uses Olanzapine; Samidorphan L-Malate as an active ingredient. Lybalvi was launched by Alkermes Inc in 2021.

Market Authorisation Date:

Lybalvi was approved by FDA for market use on 28 May, 2021.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Lybalvi is 28 May, 2021, its NCE-1 date is estimated to be 28 May, 2025

Active Ingredient:

Lybalvi uses Olanzapine; Samidorphan L-malate as the active ingredient. Check out other Drugs and Companies using Olanzapine; Samidorphan L-malate ingredient

Treatment:

Lybalvi is used for treating bipolar disorder and schizophrenia with reduced weight gain and adverse metabolic effects by combining olanzapine and samidorphan.

Dosage:

Lybalvi is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
15MG;EQ 10MG BASE TABLET Prescription ORAL
10MG;EQ 10MG BASE TABLET Prescription ORAL
5MG;EQ 10MG BASE TABLET Prescription ORAL
20MG;EQ 10MG BASE TABLET Prescription ORAL