FDA Orange Book

Generic for Livalo

Livalo contains pitavastatin. 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 Livalo is pitavastatin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Livalo products in the Orange Book

Livalo products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	EQ 1MG BASE	Marketed (Rx)	AB	8	AB
tablet, oral	EQ 2MG BASE	Marketed (Rx)	AB	8	AB
tablet, oral	EQ 4MG BASE	Marketed (Rx)	AB	8	AB

NDA 022363, held by KOWA CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic pitavastatin

Approved generic versions of Livalo
Company	ANDA	TE code	Approved	Strengths
AUROBINDO PHARMA LTD	206015	AB (A-rated, therapeutically equivalent)	December 20, 2016	EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE
ORIENT PHARMA CO LTD	205932	AB (A-rated, therapeutically equivalent)	February 3, 2017	EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE
SAWAI USA INC	205955	AB (A-rated, therapeutically equivalent)	February 3, 2017	EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE
MYLAN PHARMACEUTICALS INC	206070	AB (A-rated, therapeutically equivalent)	April 4, 2019	EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE
ZYDUS PHARMACEUTICALS USA INC	206047	AB (A-rated, therapeutically equivalent)	February 22, 2023	EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE
LUPIN LTD	206029	AB (A-rated, therapeutically equivalent)	November 20, 2023	EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE
HETERO LABS LTD UNIT V	205977	AB (A-rated, therapeutically equivalent)	April 30, 2024	EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE
AMNEAL PHARMACEUTICALS OF NY LLC	205961	AB (A-rated, therapeutically equivalent)	August 20, 2024	EQ 1MG BASE, EQ 2MG BASE, EQ 4MG BASE

Livalo NDC codes

Questions

Is there a generic for Livalo?

Yes. The generic name for Livalo is pitavastatin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Livalo?

The active ingredient in Livalo is pitavastatin, 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.