FDA Orange Book

Generic for Gablofen

Gablofen 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 Gablofen is baclofen. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Gablofen products in the Orange Book

Gablofen products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, intrathecal	0.05MG/ML	Marketed (Rx)	AP	2	AP
injectable, intrathecal	0.5MG/ML	Marketed (Rx)	AP	3	AP
injectable, intrathecal	1MG/ML	Marketed (Rx)	AP	2	AP
injectable, intrathecal	2MG/ML	Marketed (Rx)	AP	3	AP

NDA 022462, held by PIRAMAL CRITICAL CARE INC. 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 Gablofen
Company	ANDA	TE code	Approved	Strengths
AMNEAL PHARMACEUTICALS LLC	091193	AP (A-rated, therapeutically equivalent)	May 3, 2016	0.05MG/ML, 0.5MG/ML, 2MG/ML
MAIA PHARMACEUTICALS INC	210315	AP (A-rated, therapeutically equivalent)	July 30, 2019	1MG/ML
MAIA PHARMACEUTICALS INC	210048	AP (A-rated, therapeutically equivalent)	January 15, 2021	0.05MG/ML, 0.5MG/ML, 2MG/ML
RUBICON RESEARCH LTD	217324	AP (A-rated, therapeutically equivalent)	February 22, 2023	0.5MG/ML, 1MG/ML, 2MG/ML

Gablofen NDC codes

Questions

Is there a generic for Gablofen?

Yes. The generic name for Gablofen is baclofen. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

What is the generic name for Gablofen?

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

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.