Everolimus - Generic Drug Details

What are the generic sources for everolimus and what is the scope of freedom to operate?

Everolimus is the generic ingredient in four branded drugs marketed by Novartis Pharm, Amneal, Biocon Pharma, Mylan, Natco, Novartis, Alkem Labs Ltd, Breckenridge, Hikma, Novugen, Ph Health, and Teva Pharms Usa, and is included in nineteen 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. Eleven suppliers are listed for this compound.

Summary for everolimus

International Patents:	229
US Patents:	2
Tradenames:	4
Applicants:	12
NDAs:	19
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	11
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
Hikma	EVEROLIMUS	everolimus	TABLET;ORAL	206133-002	Apr 12, 2018	AB	RX	No	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012	AB	RX	Yes	No	8,410,131*PED				Y
Novugen	EVEROLIMUS	everolimus	TABLET;ORAL	219955-003	Oct 30, 2025	AB	RX	No	No
Hikma	EVEROLIMUS	everolimus	TABLET;ORAL	207486-001	Jun 8, 2020	AB	RX	No	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No	8,410,131*PED				Y
Breckenridge	EVEROLIMUS	everolimus	TABLET;ORAL	205426-001	Mar 5, 2021	AB	RX	No	No
Biocon Pharma	EVEROLIMUS	everolimus	TABLET;ORAL	214182-002	Feb 11, 2021	AB	RX	No	No

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	5,665,772*PED
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	6,004,973*PED
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012	7,297,703*PED
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	8,436,010*PED
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012	6,004,973*PED
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012	5,665,772*PED
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012	8,778,962*PED

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
European Patent Office	2783686	Association d'un dérivé de rapamycine et de létrozole pour le traitement du cancer du sein (Combination of a rapamycin derivative and letrozole for treating breast cancer)
Norway	20150831
Russian Federation	2008124827	ЛЕЧЕНИЕ НЕЙРОЭНДОКРИННЫХ ОПУХОЛЕЙ
Cyprus	1121314
Japan	2014208657	癌の処置 (CANCER TREATMENT)
Spain	2600304
Russian Federation	2018127821

Supplementary Protection Certificates for everolimus

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3342411	301032	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2269604	62/2016	Austria		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090805
3342411	C03342411/01	Switzerland		PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 17.01.2012
2269604	PA2016035	Lithuania		PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
3342411	CA 2020 00007	Denmark		PRODUCT NAME: EVEROLIMUS; REG. NO/DATE: EU/1/09/538 (K(2011)6162) 20110830
3351246	PA2019521	Lithuania		PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
0663916	04C0012	France		PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: NL 29433 20040415; FIRST REGISTRATION: SE - 18693 20030718

Market Dynamics and Financial Trajectory for Everolimus

Last updated: January 5, 2026

Executive Summary

Everolimus, a rapamycin analog (rapalog) with immunosuppressive and antineoplastic properties, has established a pivotal role across multiple therapeutic domains, notably in oncology, transplant medicine, and rare genetic disorders. Its market landscape is shaped by evolving clinical data, regulatory pathways, competitive dynamics, and shifting healthcare policies. As of 2023, the global everolimus market exhibits steady growth with projected compound annual growth rates (CAGR) approximating 7-8% over the next five years. This growth is driven by expanding indications, technological advancements, and unmet clinical needs, juxtaposed against the risks posed by patent expirations, biosimilar entry, and payer reimbursement challenges.

This comprehensive analysis delineates the current and projected market dynamics, financial trajectories, competitive landscape, and strategic opportunities surrounding everolimus. It aims to equip industry stakeholders—including pharmaceutical companies, investors, and healthcare policymakers—with critical insights to navigate this evolving landscape.

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Market Overview

Parameter	Data/Insight
Global Market Size (2022)	USD 2.2 billion (estimated)
Projected CAGR (2023-2028)	7-8%
Major Regions	North America, Europe, Asia-Pacific
Key Indications	Renal cell carcinoma, breast cancer, neuroendocrine tumors, tuberous sclerosis complex (TSC), organ transplant rejection

Current Therapeutic Indications and Revenue Drivers

Oncology Segment

Everolimus is FDA-approved for various cancers:

• Renal cell carcinoma (RCC)
• Hormone receptor-positive, HER2-negative breast cancer
• Neuroendocrine tumors (NET)
• Pancreatic neuroendocrine tumors (pNET)
• Glioblastoma (adjuvant setting)

With high clinical adoption, the oncology segment remains the primary revenue contributor, accounting for approximately 60% of total sales.

Transplantation Indications

Approved for preventing organ rejection, particularly in kidney and liver transplant recipients, the transplantation segment constitutes roughly 25% of revenue.

Rare Disease - Tuberous Sclerosis Complex

Everolimus's indications extend into rare genetic diseases like TSC, which has contributed about 10% to current revenues.

Emerging Indications

Research into additional areas—such as LAD2 (lemon-adenoma syndrome), pulmonary lymphangioleiomyomatosis, and emerging biomarker-driven therapies—is poised to expand the market base over the next decade.

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Market Dynamics

1. Drivers

• Expanding Indications & Clinical Evidence: Increasing clinical trials validate efficacy in new indications, catalyzing approval cycles.
• Retrospective Data & Real-World Evidence (RWE): RWE supports drug positioning, leading to broader payer acceptance.
• Regulatory Approvals: Accelerated approval pathways and orphan drug status facilitate market access for rare diseases.
• Technological Advancements: Improved formulations (e.g., oral tablets, nanoparticle delivery), fostering better adherence.
• Growing Oncology Burden: Rising cancer incidence globally, especially in developing countries, fuels demand.

2. Restraints

• Patent Expiry & Biosimilars: Scheduled patent cliffs for key formulations (e.g., Afinitor® for breast cancer) threaten price erosion.
• Pricing & Reimbursement Pressures: Payers scrutinize high-cost therapies, influencing formulary inclusion.
• Adverse Effect Profile: Side effects such as stomatitis and pneumonitis reduce patient adherence.
• Regulatory Delays: Emerging approval hurdles, especially in off-label indications, may slow uptake.

3. Opportunities

• Biomarker-Driven Therapies: Precision medicine approaches targeting specific molecular profiles.
• Combination Therapies: Synergistic regimens with immunotherapies or chemotherapies.
• Novel Delivery Platforms: Long-acting injectables and targeted delivery systems to improve compliance.
• Expanding Global Access: Markets in emerging economies present growth opportunities due to increased cancer screening.

4. Threats

• Competitive Pipeline: Other mTOR inhibitors (e.g., temsirolimus, sirolimus) and emerging targeted therapies may erode market share.
• Biosimilars & Generics: Increased presence diminishes pricing power and margins.
• Regulatory & Policy Changes: Stringent drug approval criteria and reimbursement policies may impact sales trajectories.

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Competitive Landscape

Competitor	Key Products	Market Share (2022)	Notable Strategies
Pfizer	Afinitor® (Everolimus)	~40%	Broad indication portfolio, strategic licensing
Novartis	Afinitor®	Included in Pfizer’s share	Focus on rare diseases and oncology
Sandoz (Novartis division)	Biosimilar everolimus	Growing ~10%	Cost-competitiveness
Other Biotechs	Various mTOR inhibitors	Remaining ~50%	Pipeline development, combination studies

Note: The market exhibits fragmented competition, with consolidation driven by licensing and M&A activities.

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Financial Trajectory and Forecasting

Revenue Projections (2023-2028)

Year	USD Billion	Growth Rate	Key Factors
2023	2.35	—	Mature market, patent enforcement
2024	2.52	+7.2%	New indications, geographic expansion
2025	2.70	+7.1%	Entry into novel indications, pipeline approvals
2026	2.89	+6.9%	Biosimilar competition impact mitigated
2027	3.08	+6.9%	Market consolidation, pricing strategies
2028	3.29	+7.0%	Continued indication expansion

Key Revenue Drivers

• Oncology indications remain dominant.
• Emerging markets expected to grow at 10% CAGR, driven by increased healthcare infrastructure.
• Biosimilar competition may suppress prices; innovation and pipeline expansion essential.

Investment and R&D Outlook

• Leading firms are investing USD 300-500 million annually in R&D for new formulations, combination therapies, and biomarker-driven trials.
• Partnerships and licensing agreements are prevalent, with Pfizer, Novartis, and Sandoz leading.

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Regulatory Policies & Reimbursement Landscape

Aspect	Details
FDA Approvals	Multiple indications including RCC, breast cancer, TSC (2009-2022)
EMA Approvals	Similar indications, with additional approvals in Europe
Reimbursement Trends	Favorable in North America and Europe; emerging markets face access hurdles
Orphan Drug Policies	Facilitate accelerated approvals for rare indications

SWOT Analysis

Strengths	Weaknesses	Opportunities	Threats
Proven efficacy across multiple cancers	Costly therapy, side effect profile	Biomarker-based therapies	Patent expirations, biosimilar competition
Strong regulatory support	Patent expiries threaten exclusivity	Global expansion	Regulatory delays in new indications
Established manufacturing & supply chain	Limited efficacy in some tumor types	Pipeline innovations	Pricing pressures, healthcare reforms

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Strategic Recommendations

• Diversify Indications: Accelerate clinical trials in emerging tumor types and rare diseases.
• Enhance Value Proposition: Focus on safety profiles and personalized therapy to differentiate.
• Engage Policymakers: Advocate for favorable reimbursement policies, especially in emerging markets.
• Invest in Biosimilar Development: Prepare for patent cliffs to mitigate revenue decline.
• Leverage Data & Real-World Evidence: Strengthen label expansion and payer negotiations.

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Key Takeaways

• Market Growth: The everolimus market is poised for steady growth (~7-8% CAGR) through 2028, driven primarily by expanded indications and geographic expansion.
• Revenue Contributors: Oncology remains the dominant segment, with an increasing share from rare diseases like TSC.
• Competitive Risks: Patent expirations and biosimilar entries threaten margins; innovation and pipeline expansion are critical.
• Regulatory & Reimbursement Environment: Favorable policies in key markets bolster growth but pose challenges in emerging economies.
• Strategic Focus: Companies should prioritize indication diversification, data-driven marketing, and biosimilar readiness to maintain market share.

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FAQs

1. What are the primary factors influencing the future sales of everolimus?

Clinical trial approvals, regulatory decisions on new indications, patent expirations, competitive biosimilars, and reimbursement policies are pivotal. Advances in personalized medicine and combination regimens will further influence sales.

2. How will patent cliffs affect revenue projections?

Patent expirations (e.g., Afinitor® patent in 2023/2024 in key markets) will introduce biosimilars, exerting downward pressure on prices and overall revenue unless mitigated by pipeline growth and new indications.

3. What markets offer the highest growth potential for everolimus?

Emerging markets in Asia-Pacific and Latin America present significant growth due to expanding healthcare infrastructure and cancer prevalence. Additionally, rare disease indications like TSC offer niche expansion.

4. How does competition from biosimilars impact the market landscape?

Biosimilars like Sandoz's everolimus are likely to reduce drug prices, erode margins, and increase market penetration, compelling innovator firms to innovate and differentiate.

5. What are the strategic opportunities for pharmaceutical companies in the everolimus market?

Targeting novel indications, developing combination therapies, leveraging biomarker-driven approaches, and investing in biosimilar development are key strategies to sustain growth amidst competitive pressures.

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References

1. GlobalData. "Everolimus Market Analysis," 2022.
2. FDA & EMA. Product approval documents, 2009-2022.
3. IQVIA. "Pharmaceutical Market Forecasts," 2022.
4. World Health Organization (WHO). Cancer statistics, 2022.
5. Pfizer Annual Reports. 2022.

Note: Data and projections are estimates based on publicly available sources as of early 2023.