Is there a generic for Everolimus?

Yes. The FDA Orange Book lists 19 approved generic (ANDA) applications for Everolimus, referencing the brand AFINITOR DISPERZ. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Everolimus?

AFINITOR DISPERZ (NDA 203985, NOVARTIS PHARM) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Everolimus?

The Orange Book lists 3 patents against Everolimus products, with the earliest listed expiry in 2025. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Everolimus are approved?

Everolimus is approved in the following dosage forms: tablet, tablet, for suspension.

FDA Orange Book · active-ingredient family

Everolimus

Everolimus: 3 brands, 19 generics; first approved Mar 30, 2009; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 19 ANDA applications approved.

Earliest patent expiry Nov 01, 2025

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Nov 01, 2025

9 mo ago

Brand (NDA) products

Originator applications

AFINITOR DISPERZRLD
NOVARTIS PHARMNDA 20398520123 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET, FOR SUSPENSION ORAL Rx AB
3MG TABLET, FOR SUSPENSION ORAL Rx AB
5MG TABLET, FOR SUSPENSION ORAL Rx AB
AFINITORRLD
NOVARTISNDA 02233420104 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
2.5MG TABLET ORAL Rx AB
7.5MG TABLET ORAL Rx AB
ZORTRESSRLD
NOVARTISNDA 02156020104 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG TABLET ORAL Rx AB
0.5MG TABLET ORAL Rx AB
0.75MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB
3MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB
5MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
2.5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
0.75MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB

Generic (ANDA) products (19)

Abbreviated applications

EVEROLIMUS
I3 PHARMSANDA 21946420264 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG TABLET ORAL Rx AB
0.5MG TABLET ORAL Rx AB
0.75MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
EVEROLIMUS
APOTEXANDA 21848820264 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
7.5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
EVEROLIMUS
EUGIA PHARMAANDA 21953320264 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG TABLET ORAL Rx AB
0.5MG TABLET ORAL Rx AB
0.75MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
EVEROLIMUS
BIOCON PHARMAANDA 21721620263 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET, FOR SUSPENSION ORAL Rx AB
3MG TABLET, FOR SUSPENSION ORAL Rx AB
5MG TABLET, FOR SUSPENSION ORAL Rx AB
EVEROLIMUS
NOVUGENANDA 21995520254 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
7.5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
EVEROLIMUS
BIOCON PHARMAANDA 21614020254 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG TABLET ORAL Rx AB
0.5MG TABLET ORAL Rx AB
0.75MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
EVEROLIMUS
NATCOANDA 21764020253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET, FOR SUSPENSION ORAL Rx AB
3MG TABLET, FOR SUSPENSION ORAL Rx AB
5MG TABLET, FOR SUSPENSION ORAL Rx AB
EVEROLIMUS
AMNEALANDA 21886320253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET, FOR SUSPENSION ORAL Rx AB
3MG TABLET, FOR SUSPENSION ORAL Rx AB
5MG TABLET, FOR SUSPENSION ORAL Rx AB
EVEROLIMUS
ALKEM LABS LTDANDA 21413820214 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG TABLET ORAL Rx AB
0.5MG TABLET ORAL Rx AB
0.75MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
EVEROLIMUS
PH HEALTHANDA 20577520214 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG TABLET ORAL Rx AB
0.5MG TABLET ORAL Rx AB
0.75MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
EVEROLIMUS
BRECKENRIDGEANDA 20543220214 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG TABLET ORAL Rx AB
0.5MG TABLET ORAL Rx AB
0.75MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
EVEROLIMUS
BRECKENRIDGEANDA 20542620214 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
7.5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
EVEROLIMUS
BIOCON PHARMAANDA 21418220214 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
7.5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
EVEROLIMUS
HIKMAANDA 20748620204 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
7.5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
EVEROLIMUS
MYLANANDA 21293620204 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
7.5MG TABLET ORAL Discontinued —
10MG TABLET ORAL Discontinued —
EVEROLIMUS
PH HEALTHANDA 20793420194 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
7.5MG TABLET ORAL Discontinued —
10MG TABLET ORAL Discontinued —
EVEROLIMUS
TEVA PHARMS USAANDA 21005020194 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
7.5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
0.75MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
0.75MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB
3MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB
5MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
0.75MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB
3MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB
5MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB
3MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB
5MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
0.75MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
0.75MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
0.75MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
7.5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
7.5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
7.5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

EVEROLIMUS

MYLANANDA 21013020193 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET, FOR SUSPENSION	ORAL	Discontinued	—
3MG	TABLET, FOR SUSPENSION	ORAL	Discontinued	—
5MG	TABLET, FOR SUSPENSION	ORAL	Discontinued	—

EVEROLIMUS
HIKMAANDA 20613320184 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25MG TABLET ORAL Rx AB
0.5MG TABLET ORAL Rx AB
0.75MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
0.75MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8410131	Nov 01, 2025	9 mo ago	U-1368
8410131*PED	May 01, 2026	3 mo ago
9006224	Jul 01, 2028	in 1 yr 11 mo	U-1681

Approval history

FDA approval span

First approval

Mar 30, 2009

17 yr 7 mo ago

Most recent approval

Jun 30, 2026

1 mo ago

Approvals span 2009–2026 across 22 FDA applications.

Brand (NDA) 314%

Generic (ANDA) 1986%

Everolimus: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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