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Last Updated: November 3, 2024

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LYBALVI Drug Patent Profile


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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 thirteen patents protecting this drug.

This drug has eighty-five patent family members in twenty-seven countries.

The generic ingredient in LYBALVI is olanzapine; samidorphan l-malate. There are thirty-three drug master file entries 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 will be eligible for patent challenges on May 28, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 30, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for LYBALVI
International Patents:85
US Patents:13
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
What excipients (inactive ingredients) are in LYBALVI?LYBALVI excipients list
DailyMed Link:LYBALVI at DailyMed
Drug patent expirations by year for LYBALVI
Drug Prices for LYBALVI

See drug prices for LYBALVI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LYBALVI
Generic Entry Date for LYBALVI*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Alkermes, Inc.Phase 1

See all LYBALVI clinical trials

Pharmacology for LYBALVI

US Patents and Regulatory Information for LYBALVI

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LYBALVI is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Patents protecting LYBALVI

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN

Composition for treating mental illness
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SCHIZOPHRENIA IN A PATIENT WHO HAS PREVIOUSLY EXPERIENCED SIGNIFICANT WEIGHT GAIN INDUCED BY OLANZAPINE ALONE BY ADMINISTERING A COMPOSITION COMPRISING OLANZAPINE AND SAMIDORPHAN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING A BILAYER TABLET COMPRISING OLANZAPINE AND SAMIDORPHAN

4-hydroxybenzomorphans
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN

Morphinan derivatives for the treatment of drug overdose
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE

Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE

FDA Regulatory Exclusivity protecting LYBALVI

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-003 May 28, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-003 May 28, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-003 May 28, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-003 May 28, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-002 May 28, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LYBALVI

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:

Australia

Patent: 10326676
Patent: Morphinan derivatives for the treatment of drug overdose
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 82529
Patent: DERIVES DE MORPHINANE POUR LE TRAITEMENT D'UNE SURDOSE DE DROGUES (MORPHINAN DERIVATIVES FOR THE TREATMENT OF DRUG OVERDOSE)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0191029
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 06712
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 06712
Patent: DÉRIVÉS DE MORPHINANE POUR LE TRAITEMENT D'UNE SURDOSE DE DROGUES (MORPHINAN DERIVATIVES FOR THE TREATMENT OF DRUG OVERDOSE)
Estimated Expiration: ⤷  Sign Up

Patent: 69234
Patent: DÉRIVÉS DE MORPHINANE POUR LE TRAITEMENT D'UNE SURDOSE DE DROGUES (MORPHINAN DERIVATIVES FOR THE TREATMENT OF DRUG OVERDOSE)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 43963
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 91042
Estimated Expiration: ⤷  Sign Up

Patent: 16305
Estimated Expiration: ⤷  Sign Up

Patent: 13512901
Estimated Expiration: ⤷  Sign Up

Patent: 15038139
Patent: 薬物過量摂取の治療のためのモルヒナン誘導体 (MORPHINAN DERIVATIVES FOR THE TREATMENT OF DRUG OVERDOSE)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 06712
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 468
Patent: DERIVATI MORFINANA ZA LIJEČENJE PREDOZIRANJA LIJEKOM (MORPHINAN DERIVATIVES FOR THE TREATMENT OF DRUG OVERDOSE)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0379
Patent: Morphinan derivatives for the treatment of drug overdose
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 06712
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 06712
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 894
Patent: DERIVATI MORFINANA ZA LEČENJE PREDOZIRANJA LEKOM (MORPHINAN DERIVATIVES FOR THE TREATMENT OF DRUG OVERDOSE)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 06712
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 29679
Estimated Expiration: ⤷  Sign Up

Turkey

Patent: 1908514
Estimated Expiration: ⤷  Sign Up

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 2002227135 ⤷  Sign Up
Germany 60133584 ⤷  Sign Up
Japan 5684388 ⤷  Sign Up
Japan 6216305 ⤷  Sign Up
Slovenia 2251330 ⤷  Sign Up
Japan 2015038139 薬物過量摂取の治療のためのモルヒナン誘導体 (MORPHINAN DERIVATIVES FOR THE TREATMENT OF DRUG OVERDOSE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LYBALVI

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.