EVEROLIMUS - Generic Drug Details

What are the generic drug sources for everolimus and what is the scope of patent protection?

Everolimus is the generic ingredient in four branded drugs marketed by Novartis Pharm, Amneal, Biocon Pharma, Mylan, Natco, Novartis, Alkem Labs Ltd, Breckenridge, Eugia Pharma, Hikma, Novugen, Ph Health, and Teva Pharms Usa, and is included in twenty NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Everolimus has two hundred and twenty-nine patent family members in thirty-one countries.

There are twelve drug master file entries for everolimus. Fourteen suppliers are listed for this compound.

Summary for EVEROLIMUS

International Patents:	229
US Patents:	2
Tradenames:	4
Applicants:	13
NDAs:	20
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	819
Patent Applications:	5,416
Drug Prices:	Drug price trends for EVEROLIMUS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVEROLIMUS
What excipients (inactive ingredients) are in EVEROLIMUS?	EVEROLIMUS excipients list
DailyMed Link:	EVEROLIMUS at DailyMed

See drug prices for EVEROLIMUS

Recent Clinical Trials for EVEROLIMUS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Verastem, Inc.	PHASE1
M.D. Anderson Cancer Center	PHASE1
Boston Children's Hospital	PHASE2

See all EVEROLIMUS clinical trials

Pharmacology for EVEROLIMUS

Drug Class	Kinase Inhibitor mTOR Inhibitor Immunosuppressant
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Medical Subject Heading (MeSH) Categories for EVEROLIMUS

Antineoplastic Agents

Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for EVEROLIMUS

L01EG	Mammalian target of rapamycin (mTOR) kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AH	Mammalian target of rapamycin (mTOR) kinase inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for EVEROLIMUS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AFINITOR DISPERZ	Tablets for Oral Suspension	everolimus	2 mg, 3 mg and 5 mg	203985	1	2016-12-30
AFINITOR	Tablets	everolimus	2.5 mg, 5 mg, and 7.5 mg	022334	1	2014-12-10
AFINITOR	Tablets	everolimus	10 mg	022334	1	2014-06-18
ZORTRESS	Tablets	everolimus	0.25 mg, 0.5 mg, and 0.75 mg	021560	3	2013-09-30

US Patents and Regulatory Information for EVEROLIMUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novugen	EVEROLIMUS	everolimus	TABLET;ORAL	219955-004	Oct 30, 2025	AB	RX	No	No
Eugia Pharma	EVEROLIMUS	everolimus	TABLET;ORAL	219533-004	Feb 25, 2026	AB	RX	No	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No
Ph Health	EVEROLIMUS	everolimus	TABLET;ORAL	207934-002	Dec 9, 2019		DISCN	No	No
Breckenridge	EVEROLIMUS	everolimus	TABLET;ORAL	205426-001	Mar 5, 2021	AB	RX	No	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	AB	RX	Yes	Yes
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	AB	RX	Yes	No					Y

Expired US Patents for EVEROLIMUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012

EU/EMA Drug Approvals for EVEROLIMUS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Afinitor	everolimus	EMEA/H/C/001038Hormone-receptor-positive advanced breast cancerAfinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.Neuroendocrine tumours of pancreatic originAfinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.Neuroendocrine tumours of gastrointestinal or lung originAfinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.Renal-cell carcinomaAfinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.	Authorised	no	no	no	2009-08-02
Novartis Europharm Limited	Votubia	everolimus	EMEA/H/C/002311Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.The evidence is based on analysis of change in sum of angiomyolipoma volume.Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease‑related symptoms, has not been demonstrated.	Authorised	no	no	no	2011-09-02

International Patents for EVEROLIMUS

Country	Patent Number	Title	Estimated Expiration
Australia	2002250968
Brazil	0207378
Canada	2438504	TRAITEMENT DES TUMEURS SOLIDES AVEC DES DERIVES DE RAPAMYCINE (TREATMENT OF SOLID TUMOURS WITH RAPAMYCIN DERIVATIVES)
Canada	2860306	TRAITEMENT DES TUMEURS SOLIDES AVEC DES DERIVES DE RAPAMYCINE (TREATMENT OF SOLID TUMORS WITH RAPAMYCIN DERIVATIVES)
Canada	2994779	UTILISATION DE 40-O-(2-HYDROXYETHYL)-RAPAMYCINE POUR EMPECHER LA CROISSANCE D'UNE TUMEUR SOLIDE AU CERVEAU AUTRE QU'UN CANCER LYMPHATIQUE (USE OF 40-O-(2-HYDROXYETHYL)-RAPAMYCIN FOR INHIBITING GROWTH OF A SOLID TUMOUR OF THE BRAIN OTHER THAN LYMPHATIC CANCER)
China	104083365
China	104116738

Supplementary Protection Certificates for EVEROLIMUS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3143995	C03143995/01	Switzerland		PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 14.11.2016
2269604	300849	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
3342411	CA 2020 00007	Denmark		PRODUCT NAME: EVEROLIMUS; REG. NO/DATE: EU/1/09/538 (K(2011)6162) 20110830
2269604	122016000094	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
2269604	2016C/075	Belgium		DETAILS LICENCE: LICENCE, ENREGISTREMENT D'UNE NOUVELLE LICENCE
3351246	2019C/550	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
3143995	2019C/528	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION

Everolimus Market Dynamics and Financial Trajectory (Revenue Drivers, Exclusivity Risk, and Competitive Pressure)

Last updated: June 19, 2026

Everolimus is a commercially established oncology and renal therapy with a concentrated patent and exclusivity timeline shaped by multiple indications and dosage forms. Revenue has been driven by (1) sustained use in breast cancer (HR+/HER2−), renal cell carcinoma (RCC), and pancreatic neuroendocrine tumors (NET), and (2) competitive substitution pressure from other pathway inhibitors and, in select contexts, from end of exclusivity for specific formulation or method-of-use IP layers. Financial trajectory also reflects net-price pressure, channel mix (hospital vs. specialty pharmacy), and guideline positioning against VEGF TKIs and mTOR-adjacent regimens.

How has Everolimus performed financially by indication (oncology and renal use cases)?

Everolimus’ financial profile is best understood as a blended outcome of three major demand engines:

• RCC (advanced RCC after prior VEGF-targeted therapy; also used across related renal indications)
• Breast cancer (HR+/HER2−, usually with aromatase inhibitors)
• Pancreatic NET and other NET subsets (where mTOR inhibition fits specific sequencing)

Key demand drivers

• Treatment sequencing: mTOR inhibitors typically sit after initial lines (commonly post-VEGF TKI in RCC and post-progression in HR+ breast cancer combination strategies).
• Patient selection: benefits concentrate in populations aligned with clinical inclusion criteria (performance status, prior therapy constraints, and biomarker-relevant clinical features).
• Dose continuity: fixed oral dosing and long-cycle administration supports durability, but dose reductions and interruptions occur due to stomatitis, infections, hyperglycemia, pneumonitis, and cytopenias.

What the market cares about

• durable prescribing by line of therapy
• tolerability management protocols
• payer access and formulary placement versus alternative kinase inhibitors and antibody-drug conjugates (ADC) in breast cancer lines

What market dynamics shape Everolimus pricing and net revenue?

Everolimus is exposed to typical specialty drug economics, but the price/net realization is modulated by indication mix and regional payer behavior.

Hospital procurement vs. specialty pharmacy dynamics

• Oncology settings in major markets often route through hospital formularies and specialty pharmacy chains.
• NET and RCC use tends to concentrate in specialty centers with stable prescribing workflows.

Net price pressure mechanics

• Annual contract renewals and rebundling pressures in US commercial and Medicare Part D settings.
• International tender mechanisms in EU and ROW that can force price resets.

Competitive substitution pressures

Everolimus faces two broad competitive classes:

• Within oncology pathways: VEGF inhibitors and other targeted agents in RCC; CDK4/6 inhibitors, SERDs, and ADCs in HR+ breast cancer over time.
• Within mTOR-class alternatives and sequencing changes: shifts in guidelines can reduce incremental share even if the drug remains an option.

Real-world adherence and dose management

Everolimus net revenue is affected by:

• discontinuation rates from adverse events
• dose interruption patterns during grade 2-4 events
• cost-offset dynamics when dose reductions are adopted rather than switching therapies

When does Everolimus exclusivity end and how does it affect financial trajectory?

Everolimus commercial continuity is driven by a multi-layer exclusivity stack:

• drug substance/exposure period
• formulation and polymorph layers
• method-of-use protections by indication
• regulatory exclusivities tied to specific labeling

Because the financial impact is indication-dependent, generic or biosimilar entry risk is not uniform. The most material effect comes from exclusivity loss for specific tablet strengths and line-specific method-of-use claims (and any FDA “Orange Book” active patent coverage that blocks/limits generic labeling).

Exclusivity timing: why it is not a single date

For oral oncology agents, market access barriers are usually layered. Even when one IP layer expires, others can delay:

• first generic approval in the same strength and dosing regimen
• label carve-outs or litigation settlement-driven “at-risk” entries

Financial consequence

• revenue usually plateaus until the dominant Orange Book blocking patents lapse, then declines more abruptly during first generic launches that align to label and dosing.

What is the Orange Book status for Everolimus, and which patent barriers matter most?

Everolimus’ Orange Book status is assessed by:

• listed patents tied to the NDA and specific dosage forms
• patent expiration dates and any statutory exclusivity codes (where applicable)
• whether key claims are method-of-use (indication) or formulation/manufacturing-related

Practical market effect

• If Orange Book listings include method-of-use claims for core indications (RCC, breast, NET), generics may file with label carve-outs or enter after litigation resolution.
• If formulation/manufacturing patents remain in force, launch may be delayed even when method-of-use patents are not asserted.

Which companies control Everolimus supply and how do their strategies influence revenue?

Everolimus is marketed through established specialty product channels and, in later periods, also via authorized generics where legal and regulatory pathways allow. Competitive dynamics typically include:

• maintaining formulary coverage through contracting
• supporting payer evidence packages and real-world outcomes
• lifecycle management through label expansions and dose optimization

Strategy patterns that affect financial trajectory

• aggressive tender/contract renegotiation
• specialty pharmacy distribution agreements
• bundling with patient support programs that improve persistence
• REMS and safety monitoring infrastructure for oral oncology adherence

What patent litigation and Paragraph IV challenges affect Everolimus revenue risk?

Generic entry risk is shaped by:

• the number of Orange Book blocking patents
• the scope and strength of asserted claims
• settlement outcomes (which often include “no-authorization” periods, launch date constraints, and/or market allocation terms)

Financial trajectory impact pathways

• At-risk litigation can cause a delayed launch if courts issue injunctions tied to claim scope.
• Settlements can create a predictable post-expiry entry date that compresses revenue in a narrower window.
• Label carve-outs can reduce the addressable patient population, slowing revenue erosion even after approval.

How does Everolimus compare with competing oncology drugs in market resilience?

Everolimus competes against agents with different risk-reward profiles. The resilience of everolimus revenue depends on how clinicians sequence mTOR inhibition versus:

• VEGF pathway inhibitors in RCC
• endocrine combinations, SERDs, and targeted therapies in HR+ breast cancer
• other targeted agents and chemotherapy regimens in NET sequencing

Comparison dimensions that matter commercially

• OS/PFS relative positioning in guidelines over time
• tolerability and monitoring burden
• ability to integrate with existing regimens without major contraindication overlap
• payer acceptance and net-price contracting

What biosimilar risk applies to Everolimus?

Everolimus is a small-molecule drug, so biosimilar risk does not apply. Competitive risk is primarily from:

• small-molecule generics
• authorized generics
• label carve-out strategies tied to remaining method-of-use or formulation patents

Which dosage forms and strengths drive substitution dynamics for Everolimus generics?

Substitution is driven by whether a generic can match:

• strength and dosing flexibility
• release profile and excipient formulation that meets bioequivalence standards
• ability to carry the same label for key indications without carve-outs

Financial implication

• a generic that can only reference a subset of strengths or must narrow indications tends to capture less revenue initially.
• full label and strength matching is usually required for a steep revenue decline.

How do revenue drivers shift over time as indications mature?

Everolimus demand tends to evolve as:

• treatment algorithms change
• newer lines of therapy gain uptake
• payer restrictions tighten around high-cost oral therapies

Mature-indication patterns

• breast cancer share can be diluted by newer endocrine and targeted options that move earlier in the line sequence
• RCC remains a long-lived oncology market with continuing progression-driven need for options, sustaining demand even as competitors expand

NET-specific patterns

• NET is sensitive to sequencing and local care pathways
• longer-term chronic administration supports persistence if patients tolerate therapy

What are the most plausible generic launch scenarios for Everolimus and their financial impact?

Three launch pathways govern revenue outcomes:

Scenario A: Early full-label generic entry

• High revenue compression soon after exclusivity/Orange Book barriers lapse.
• Often results from favorable litigation outcomes or absence of blocking patents for core indications.

Scenario B: Delayed or partial-label entry

• Launch occurs but with label carve-outs for the dominant indications.
• Revenue erosion is slower because prescribers remain with the originator for the covered populations.

Scenario C: Settlement-constrained entry dates

• Delay persists until a settlement-driven launch date.
• Revenue declines begin around that date rather than at the earliest legal patent expiry.

Market pattern

• Scenario B is the most common in complex oncology labeling when multiple method-of-use patents remain in force.

Key timeline: what to watch in Everolimus exclusivity and entry windows

Because Everolimus’ exclusivity is layered across NDA-linked patents and possibly multiple dosage forms, revenue inflection typically aligns with one of these event types:

• expiration of the last Orange Book blocking patent for the core commercial label
• resolution of litigation via court decision or settlement that removes injunction risk
• FDA approval of a generic with label that covers the key indications
• uptake of competing therapies that changes guideline sequencing

Key Takeaways

• Everolimus revenue is driven by core oncology and renal indications, with financial durability tied to treatment sequencing and patient selection.
• Market dynamics include net price pressure from contracting and substitution pressure from newer targeted agents that shift earlier line utilization.
• Generic revenue risk is not one-date; it depends on layered Orange Book patent coverage across method-of-use and formulation/manufacturing protections.
• The magnitude and speed of revenue erosion depends on whether generic entrants can launch with full label coverage and matching dosage strengths, or whether they face litigation-driven delays or label carve-outs.
• Biosimilar risk does not apply because everolimus is a small molecule; competitive threats are primarily from small-molecule generics and authorized generics.

FAQs

1) What is the main commercial exposure for Everolimus across its labeled indications?

Commercial exposure concentrates in RCC, HR+/HER2− breast cancer, and pancreatic NET subsets, where sequencing and payer access determine net revenue.

2) Do Everolimus generics typically launch with full label for RCC and breast cancer?

Not necessarily. Method-of-use patent coverage often leads to label carve-outs or delayed full-label entry.

3) What patents usually block generic entry for oncology oral mTOR inhibitors like Everolimus?

Blocking patents commonly include method-of-use claims tied to specific indications and formulation/manufacturing patents tied to dosage forms and strengths.

4) How does patient tolerability affect Everolimus long-term sales?

Adverse event management drives adherence and persistence, which affects treatment duration and pharmacy fills, especially in chronic NET use.

5) What competitive developments most threaten Everolimus revenue over a multi-year horizon?

Guideline shifts that move competing agents earlier in line of therapy, plus payer-driven net price pressure and formulary competition from newer targeted regimens.

References

1. FDA. Approved Drug Products: Everolimus (NDA database and Orange Book listings). U.S. Food and Drug Administration.
2. FDA. Drugs@FDA: Everolimus labeling history and approval records. U.S. Food and Drug Administration.
3. Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entries for everolimus-linked products. U.S. FDA.
4. Published clinical label and prescribing information for everolimus by indication (RCC, breast cancer, NET). U.S. FDA-approved labeling.