FDA Orange Book

Generic for Afinitor

Afinitor 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 Afinitor is everolimus. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Afinitor products in the Orange Book

Afinitor products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	10MG	Marketed (Rx)	AB	6	AB
tablet, oral	2.5MG	Marketed (Rx)	AB	6	AB
tablet, oral	5MG	Marketed (Rx)	AB	6	AB
tablet, oral	7.5MG	Marketed (Rx)	AB	6	AB

NDA 022334, 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 Afinitor
Company	ANDA	TE code	Approved	Strengths
TEVA PHARMACEUTICALS USA INC	210050	AB (A-rated, therapeutically equivalent)	December 9, 2019	10MG, 2.5MG, 5MG, 7.5MG
BIOCON PHARMA LTD	214182	AB (A-rated, therapeutically equivalent)	February 11, 2021	10MG, 2.5MG, 5MG, 7.5MG
BRECKENRIDGE PHARMACEUTICAL INC	205426	AB (A-rated, therapeutically equivalent)	March 5, 2021	10MG, 2.5MG, 5MG, 7.5MG
HIKMA PHARMACEUTICALS USA INC	207486	AB (A-rated, therapeutically equivalent)	November 23, 2021	10MG, 2.5MG, 5MG, 7.5MG
NEOCUBES PHARMA LLP	219955	AB (A-rated, therapeutically equivalent)	October 30, 2025	10MG, 2.5MG, 5MG, 7.5MG
APOTEX INC	218488	AB (A-rated, therapeutically equivalent)	May 12, 2026	10MG, 2.5MG, 5MG, 7.5MG

Afinitor patents

Patents listed for Afinitor
Patent	Expires	Covers	Use code	NDA
8410131	November 1, 2025	Method of use	U-1368	022334
8410131*PED	May 1, 2026	Method of use	None	022334
9006224	July 1, 2028	Method of use	U-1681	022334

Afinitor NDC codes

Questions

Is there a generic for Afinitor?

Yes. The generic name for Afinitor is everolimus. 6 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 Afinitor?

The active ingredient in Afinitor is everolimus, per the FDA Orange Book.

When does the Afinitor patent expire?

The last patent listed for Afinitor in the Orange Book expires July 1, 2028. 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.