Details for New Drug Application (NDA): 213378
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NDA 213378 describes LYBALVI, which is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the LYBALVI profile page.
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.
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.
Summary for 213378
| Tradename: | LYBALVI |
| Applicant: | Alkermes Inc |
| Ingredient: | olanzapine; samidorphan l-malate |
| Patents: | 13 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213378
Generic Entry Date for 213378*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 213378
| Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 213378
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378 | NDA | Alkermes, Inc. | 65757-651 | 65757-651-40 | 1 BOTTLE in 1 CARTON (65757-651-40) / 7 TABLET, FILM COATED in 1 BOTTLE |
| LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378 | NDA | Alkermes, Inc. | 65757-651 | 65757-651-41 | 1 BOTTLE in 1 CARTON (65757-651-41) / 7 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;EQ 10MG BASE | ||||
| Approval Date: | May 28, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,300,054 | Patent Expiration: | Aug 23, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN | ||||||||
| Patent: | 10,300,054 | Patent Expiration: | Aug 23, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN | ||||||||
Expired US Patents for NDA 213378
| 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 | 8,252,929 | ⤷ Subscribe |
| Alkermes Inc | LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378-004 | May 28, 2021 | 8,252,929 | ⤷ Subscribe |
| Alkermes Inc | LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378-004 | May 28, 2021 | 7,956,187 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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