FDA Orange Book

Generic for Ozobax

Ozobax contains baclofen. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Ozobax is baclofen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

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Ozobax products in the Orange Book

Ozobax products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution, oral	5MG/5ML	Discontinued	None	1	None

NDA 208193, held by ROSEMOUNT PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic baclofen

Approved generic versions of Ozobax
Company	ANDA	TE code	Approved	Strengths
RUBICON RESEARCH LTD	214445	None (No TE code listed)	December 6, 2024	5MG/5ML

Ozobax patents

Patents listed for Ozobax
Patent	Expires	Covers	Use code	NDA
10610502	August 30, 2039	Method of use	U-2779	208193

Ozobax NDC codes

Questions

Is there a generic for Ozobax?

Yes. The generic name for Ozobax is baclofen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

What is the generic name for Ozobax?

The active ingredient in Ozobax is baclofen, per the FDA Orange Book.

When does the Ozobax patent expire?

The last patent listed for Ozobax in the Orange Book expires August 30, 2039. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.