Last Updated: September 24, 2026

Details for Patent: 12,390,474


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Which drugs does patent 12,390,474 protect, and when does it expire?

Patent 12,390,474 protects LYBALVI and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 12,390,474
Title:Immediate release multilayer tablet
Abstract:Described herein, in part, are tablets, such as immediate release multi-layer or bilayer tablets for orally delivering olanzapine and samidorphan, methods of using said tablets in the treatment of disorders described herein, and kits comprising said tablets.
Inventor(s):Renato A. Chiarella, Hector Guzman, Paul Hurley, David Manser, Kristopher Perkin
Assignee: Alkermes Pharma Ireland Ltd
Application Number:US18/510,585
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,390,474
Patent Claim Types:
see list of patent claims
Composition; Compound; Delivery; Dosage form;

Drugs Protected by US Patent 12,390,474

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-001 May 28, 2021 RX Yes Yes 12,390,474 ⤷  Start Trial Y ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-002 May 28, 2021 RX Yes No 12,390,474 ⤷  Start Trial Y ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-003 May 28, 2021 RX Yes No 12,390,474 ⤷  Start Trial Y ⤷  Start Trial
Alkermes Inc LYBALVI olanzapine; samidorphan l-malate TABLET;ORAL 213378-004 May 28, 2021 RX Yes No 12,390,474 ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 12,390,474

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 4243768 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2022101444 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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