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Last Updated: December 11, 2024

Olanzapine; samidorphan l-malate - Generic Drug Details


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What are the generic sources for olanzapine; samidorphan l-malate and what is the scope of patent protection?

Olanzapine; samidorphan l-malate is the generic ingredient in one branded drug marketed by Alkermes Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olanzapine; samidorphan l-malate has eighty-five patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for olanzapine; samidorphan l-malate
International Patents:85
US Patents:13
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:olanzapine; samidorphan l-malate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for olanzapine; samidorphan l-malate
Generic Entry Date for olanzapine; samidorphan l-malate*:
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 olanzapine; samidorphan l-malate
Anatomical Therapeutic Chemical (ATC) Classes for olanzapine; samidorphan l-malate

US Patents and Regulatory Information for olanzapine; samidorphan l-malate

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 213378-001 May 28, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-002 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 213378-004 May 28, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-001 May 28, 2021 RX Yes Yes ⤷  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
>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 olanzapine; samidorphan l-malate

International Patents for olanzapine; samidorphan l-malate

Country Patent Number Title Estimated Expiration
Montenegro 03468 DERIVATI MORFINANA ZA LIJEÄŒENJE PREDOZIRANJA LIJEKOM (MORPHINAN DERIVATIVES FOR THE TREATMENT OF DRUG OVERDOSE) ⤷  Sign Up
Canada 2807965 ⤷  Sign Up
Portugal 2506712 ⤷  Sign Up
Slovenia 2251330 ⤷  Sign Up
Japan 5691042 ⤷  Sign Up
South Korea 20070085723 4-HYDROXYBENZOMORPHANS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for olanzapine; samidorphan l-malate

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.