Last Updated: June 27, 2026

Details for Patent: 12,589,075


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Which drugs does patent 12,589,075 protect, and when does it expire?

Patent 12,589,075 protects AUSTEDO XR and is included in one NDA.

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

Summary for Patent: 12,589,075
Title:Osmotic dosage forms comprising deutetrabenazine and methods of use thereof
Abstract:Provided herein are osmotic dosage forms containing deutetrabenazine for use in the treatment of, e.g., hyperkinetic movement disorders. When orally administered to a subject on a once-daily basis, the dosage forms provide a favorable pharmacokinetic profile for the active agent indicating treatment efficacy over an extended period of time.
Inventor(s):Parag Shah, Mayank Joshi, Soumen Pattanayek, Divyang Patel, Sandeep Pandita
Assignee: Auspex Pharmaceuticals Inc
Application Number:US18/609,809
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Device; Dosage form;

Drugs Protected by US Patent 12,589,075

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Teva AUSTEDO XR deutetrabenazine TABLET, EXTENDED RELEASE;ORAL 216354-001 Feb 17, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial A METHOD OF TREATING HUNTINGTON'S CHOREA ⤷  Start Trial
Teva AUSTEDO XR deutetrabenazine TABLET, EXTENDED RELEASE;ORAL 216354-001 Feb 17, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF TARDIVE DYSKINESIA ⤷  Start Trial
Teva AUSTEDO XR deutetrabenazine TABLET, EXTENDED RELEASE;ORAL 216354-002 Feb 17, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial A METHOD OF TREATING HUNTINGTON'S CHOREA ⤷  Start Trial
Teva AUSTEDO XR deutetrabenazine TABLET, EXTENDED RELEASE;ORAL 216354-002 Feb 17, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF TARDIVE DYSKINESIA ⤷  Start Trial
Teva AUSTEDO XR deutetrabenazine TABLET, EXTENDED RELEASE;ORAL 216354-008 Jul 1, 2024 RX Yes No ⤷  Start Trial ⤷  Start Trial A METHOD OF TREATING HUNTINGTON'S CHOREA ⤷  Start Trial
Teva AUSTEDO XR deutetrabenazine TABLET, EXTENDED RELEASE;ORAL 216354-008 Jul 1, 2024 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF TARDIVE DYSKINESIA ⤷  Start Trial
Teva AUSTEDO XR deutetrabenazine TABLET, EXTENDED RELEASE;ORAL 216354-003 Feb 17, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial A METHOD OF TREATING HUNTINGTON'S CHOREA ⤷  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 12,589,075

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 122596 ⤷  Start Trial
Australia 2021288087 ⤷  Start Trial
Australia 2023204103 ⤷  Start Trial
Australia 2025205457 ⤷  Start Trial
Brazil 112022025185 ⤷  Start Trial
Canada 3186425 ⤷  Start Trial
Canada 3257711 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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