FDA Orange Book

Generic for Zortress

Zortress contains everolimus. 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 Zortress is everolimus. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Zortress products in the Orange Book

Zortress products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	0.25MG	Marketed (Rx)	AB	7	AB
tablet, oral	0.5MG	Marketed (Rx)	AB	7	AB
tablet, oral	0.75MG	Marketed (Rx)	AB	7	AB
tablet, oral	1MG	Marketed (Rx)	AB	7	AB

NDA 021560, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic everolimus

Approved generic versions of Zortress
Company	ANDA	TE code	Approved	Strengths
HIKMA PHARMACEUTICALS USA INC	206133	AB (A-rated, therapeutically equivalent)	April 12, 2018	0.25MG, 0.5MG, 0.75MG, 1MG
BRECKENRIDGE PHARMACEUTICAL INC	205432	AB (A-rated, therapeutically equivalent)	May 20, 2021	0.25MG, 0.5MG, 0.75MG, 1MG
PH HEALTH LTD	205775	AB (A-rated, therapeutically equivalent)	October 18, 2021	0.25MG, 0.5MG, 0.75MG, 1MG
ALKEM LABORATORIES LTD	214138	AB (A-rated, therapeutically equivalent)	November 26, 2021	0.25MG, 0.5MG, 0.75MG, 1MG
BIOCON PHARMA LTD	216140	AB (A-rated, therapeutically equivalent)	April 9, 2025	0.25MG, 0.5MG, 0.75MG, 1MG
EUGIA PHARMA SPECIALITIES LTD	219533	AB (A-rated, therapeutically equivalent)	February 25, 2026	0.25MG, 0.5MG, 0.75MG, 1MG
PHARMAZONE	219464	AB (A-rated, therapeutically equivalent)	June 30, 2026	0.25MG, 0.5MG, 0.75MG, 1MG

Zortress NDC codes

Questions

Is there a generic for Zortress?

Yes. The generic name for Zortress is everolimus. 7 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 Zortress?

The active ingredient in Zortress is everolimus, 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.