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 twelve patents protecting this drug.
This drug has eighty-two 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
Summary for LYBALVI
| International Patents: | 82 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 1 |
| Patent Applications: | 11 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LYBALVI |
| What excipients (inactive ingredients) are in LYBALVI? | LYBALVI excipients list |
| DailyMed Link: | LYBALVI at DailyMed |
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
| Sponsor | Phase |
|---|---|
| Alkermes, Inc. | Phase 1 |
Pharmacology for LYBALVI
| Drug Class | Atypical Antipsychotic Opioid Antagonist |
| Mechanism of Action | Opioid Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for LYBALVI
US Patents and Regulatory Information for LYBALVI
LYBALVI is protected by eighteen US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LYBALVI is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
Composition for treating mental illness
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
4-hydroxybenzomorphans
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for treating antipsychotic-induced weight gain
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alkermes Inc | LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378-004 | May 28, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alkermes Inc | LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378-003 | May 28, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Alkermes Inc | LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378-003 | May 28, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alkermes Inc | LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378-002 | May 28, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alkermes Inc | LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378-001 | May 28, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alkermes Inc | LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378-002 | May 28, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Alkermes Inc | LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378-001 | May 28, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 82529
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0191029
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 06712
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 06712
Estimated Expiration: ⤷ Try a Trial
Patent: 69234
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 43963
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 91042
Estimated Expiration: ⤷ Try a Trial
Patent: 16305
Estimated Expiration: ⤷ Try a Trial
Patent: 13512901
Estimated Expiration: ⤷ Try a Trial
Patent: 15038139
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 06712
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 468
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0379
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 06712
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 06712
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 894
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 06712
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 29679
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1908514
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| European Patent Office | 2251330 | 4-Hydroxybenzomorphanes (4-Hydroxybenzomorphans) | ⤷ Try a Trial |
| Germany | 60133584 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2022101444 | ⤷ Try a Trial | |
| Finland | 3446565 | ⤷ Try a Trial | |
| >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 | ⤷ Try a Trial | PRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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