Generic Ozobax Availability
Last updated on Jun 11, 2025.
See also: Generic Ozobax DS
Ozobax is a brand name of baclofen, approved by the FDA in the following formulation(s):
OZOBAX (baclofen - solution;oral)
-
Manufacturer: METACEL PHARMS LLC
Approval date: September 18, 2019
Strength(s): 5MG/5ML (discontinued) [RLD] [AB]
All of the above formulations have been discontinued.
Is there a generic version of Ozobax available?
An Authorized Generic version of Ozobax has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.
List of authorized generic versions:
- Baclofen ORAL SOLUTION 10 mg/5mL
TRUPHARMA, LLC
NDC Code: 528170620 - Baclofen ORAL SOLUTION 5 mg/5mL
Palmetto Pharmaceuticals Inc.
NDC Code: 681340401 - Baclofen ORAL SOLUTION 10 mg/5mL
Palmetto Pharmaceuticals Inc.
NDC Code: 681340403 - Baclofen ORAL SOLUTION 10 mg/5mL
Sarras Health LLC
NDC Code: 728340602
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ozobax. 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.
-
Oral baclofen solutions
Patent 10,610,502
Issued: April 7, 2020
Inventor(s): Bryant Thomas Jeffrey & Thomas H. Greg
Assignee(s): Metacel Pharmaceuticals, LLCThe present disclosure relates to aqueous oral solutions comprising baclofen. In one embodiment, the aqueous oral solutions comprise a buffer comprising citric acid, a salt of citric acid, or any combination thereof, and are stored at from about 2° C. to about 8° C. The present disclosure also relates to buffer free aqueous oral solutions comprising baclofen. Additionally, the present disclosure relates to an assay for determining the amount of an impurity, 4-(3-carboxymethyl)-3-hydroxy-2,5-dioxopyrrolidin-1-yl)-3-(4-chlorophenyl)butanoic acid, in a baclofen containing solution, and to methods of treatment using such aqueous oral solutions.
Patent expiration dates:
- August 30, 2039✓
- August 30, 2039
More about Ozobax (baclofen)
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- Drug class: skeletal muscle relaxants
- Breastfeeding
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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. |
| AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.