FDA Orange Book

Generic for Fleqsuvy

Fleqsuvy 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 Fleqsuvy is baclofen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Fleqsuvy products in the Orange Book

Fleqsuvy products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
suspension, oral	25MG/5ML	Marketed (Rx)	AB	1	AB

NDA 215602, held by AZURITY PHARMACEUTICALS 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 Fleqsuvy
Company	ANDA	TE code	Approved	Strengths
ANI PHARMACEUTICALS INC	217252	AB (A-rated, therapeutically equivalent)	June 8, 2023	25MG/5ML

Fleqsuvy patents

Patents listed for Fleqsuvy
Patent	Expires	Covers	Use code	NDA
11446246	September 8, 2037	Method of use	U-3433	215602
11324696	September 29, 2037	Drug product	None	215602

Fleqsuvy NDC codes

Questions

Is there a generic for Fleqsuvy?

Yes. The generic name for Fleqsuvy is baclofen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Fleqsuvy?

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

When does the Fleqsuvy patent expire?

The last patent listed for Fleqsuvy in the Orange Book expires September 29, 2037. 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.