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. Lybalvi's patents will be open to challenges from 28 May, 2025. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9119848 | Morphinan derivatives for the treatment of drug overdose |
Aug, 2031
(6 years from now) | Active |
| US7262298 | 4-hydroxybenzomorphans |
Nov, 2025
(11 months from now) | Active |
| US8252929 | 8-carboxamido-2,6-methano-3-benzazocines |
Oct, 2021
(3 years ago) |
Expired
|
| US7956187 | Method for decreasing opioid metabolism |
Oct, 2021
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11951111 | Immediate release multilayer tablet |
Nov, 2041
(16 years from now) | Active |
| US11707466 | Immediate release multilayer tablet |
Nov, 2041
(16 years from now) | Active |
| US8778960 | Methods for treating antipsychotic-induced weight gain |
Feb, 2032
(7 years from now) | Active |
| US9126977 | Methods for treating antipsychotic-induced weight gain |
Aug, 2031
(6 years from now) | Active |
| US11793805 | Methods for treating antipsychotic-induced weight gain |
Aug, 2031
(6 years from now) | Active |
| US11351166 | Methods for treating antipsychotic-induced weight gain |
Aug, 2031
(6 years from now) | Active |
| US11185541 | Methods for treating antipsychotic-induced weight gain |
Aug, 2031
(6 years from now) | Active |
| US11241425 | Composition for treating mental illness |
Aug, 2031
(6 years from now) | Active |
| US9517235 | Methods for treating antipsychotic-induced weight gain |
Aug, 2031
(6 years from now) | Active |
| US10716785 | Methods for treating antipsychotic-induced weight gain |
Aug, 2031
(6 years from now) | Active |
| US10300054 | Methods for treating antipsychotic-induced weight gain |
Aug, 2031
(6 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Lybalvi's patents.
Latest Legal Activities on Lybalvi's Patents
Given below is the list of recent legal activities going on the following patents of Lybalvi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Jun, 2024 | US9517235 |
| Maintenance Fee Reminder Mailed Critical | 15 Apr, 2024 | US8252929 |
| Email Notification Critical | 09 Apr, 2024 | US11951111 |
| Recordation of Patent Grant Mailed Critical | 09 Apr, 2024 | US11951111 |
| Mail Patent eGrant Notification | 09 Apr, 2024 | US11951111 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Apr, 2024 | US11951111 |
| Recordation of Patent eGrant | 09 Apr, 2024 | US11951111 |
| Patent eGrant Notification | 09 Apr, 2024 | US11951111 |
| Email Notification Critical | 21 Mar, 2024 | US11951111 |
| Issue Notification Mailed Critical | 20 Mar, 2024 | US11951111 |
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 |
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
Explore Our Curated Drug Screens
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.
Approval Date:
Lybalvi was approved by FDA for market use on 28 May, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 |
|---|---|---|---|
| 5MG;EQ 10MG BASE | TABLET | Prescription | ORAL |
| 20MG;EQ 10MG BASE | TABLET | Prescription | ORAL |
| 15MG;EQ 10MG BASE | TABLET | Prescription | ORAL |
| 10MG;EQ 10MG BASE | TABLET | Prescription | ORAL |