Generic Ontralfy Availability
Last updated on May 7, 2025.
Ontralfy is a brand name of tizanidine, approved by the FDA in the following formulation(s):
ONTRALFY (tizanidine hydrochloride - solution;oral)
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Manufacturer: FIDELITY BIOPHARMA
Approval date: December 12, 2024
Strength(s): EQ 2MG BASE/5ML [RLD]
Is there a generic version of Ontralfy available?
No. There is currently no therapeutically equivalent version of Ontralfy available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ontralfy. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Tizanidine liquid preparation and use thereof
Patent 12,042,484
Issued: July 23, 2024
Inventor(s): Chen; Gang et al.
Assignee(s): FIDELITY BIOPHARMA CO. (New Haven, CT)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.
Patent expiration dates:
- May 7, 2042✓✓
- May 7, 2042
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Tizanidine liquid preparation and use thereof
Patent 12,263,158
Issued: April 1, 2025
Inventor(s): Chen; Gang et al.
Assignee(s): FIDELITY BIOPHARMA CO. (New Haven, CT)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.
Patent expiration dates:
- May 7, 2042✓✓
- May 7, 2042
More about Ontralfy (tizanidine)
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- Drug class: skeletal muscle relaxants
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.