Last Updated: September 24, 2026

Details for Patent: 12,263,158


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Which drugs does patent 12,263,158 protect, and when does it expire?

Patent 12,263,158 protects ONTRALFY and is included in one NDA.

This patent has ten patent family members in seven countries.

Summary for Patent: 12,263,158
Title:Tizanidine liquid preparation and use thereof
Abstract:A tizanidine liquid preparation and use of the tizanidine liquid preparation in the preparation of a medicament for treating muscle spasm, wherein the tizanidine liquid preparation comprises an active ingredient, disodium EDTA and other pharmaceutical excipients, wherein the active ingredient is one or more of tizanidine or a pharmaceutically acceptable salt, solvate and hydrate thereof.
Inventor(s):Gang Chen, Gongzheng CHEN, Song Lin, Rashmi Rohit PRASADE, Ganesh Dattatray CHAVAN PATIL
Assignee: Fidelity Biopharma Co
Application Number:US17/918,130
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;

Drugs Protected by US Patent 12,263,158

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Fidelity Biopharma ONTRALFY tizanidine hydrochloride SOLUTION;ORAL 216190-001 Dec 12, 2024 RX Yes Yes 12,263,158 ⤷  Start Trial Y TREATMENT OF SPASTICITY ⤷  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

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