AFINITOR Drug Patent Profile

When do Afinitor patents expire, and what generic alternatives are available?

Afinitor is a drug marketed by Novartis and Novartis Pharm and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in AFINITOR is everolimus. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the everolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Afinitor

A generic version of AFINITOR was approved as everolimus by HIKMA on April 12^th, 2018.

Summary for AFINITOR

International Patents:	229
US Patents:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	182
Drug Prices:	Drug price information for AFINITOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AFINITOR
What excipients (inactive ingredients) are in AFINITOR?	AFINITOR excipients list
DailyMed Link:	AFINITOR at DailyMed

See drug prices for AFINITOR

Recent Clinical Trials for AFINITOR

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

Sponsor	Phase
National Institute on Aging (NIA)	EARLY_PHASE1
The University of Texas Health Science Center at San Antonio	EARLY_PHASE1
Fudan University	Phase 3

See all AFINITOR clinical trials

Pharmacology for AFINITOR

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

Paragraph IV (Patent) Challenges for AFINITOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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

US Patents and Regulatory Information for AFINITOR

AFINITOR is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	AB	RX	Yes	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	AB	RX	Yes	Yes					Y
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	AB	RX	Yes	No					Y
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No					Y
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	AB	RX	Yes	Yes

Expired US Patents for AFINITOR

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

EU/EMA Drug Approvals for AFINITOR

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 AFINITOR

See the table below for patents covering AFINITOR around the world.

Country	Patent Number	Title	Estimated Expiration
Luxembourg	91104
Denmark	3351246
Poland	324502
Japan	3117462
Slovakia	283572
Portugal	1137439

Supplementary Protection Certificates for AFINITOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3351246	122019000102	Germany		PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
2269603	132015000073030	Italy		PRODUCT NAME: EVEROLIMUS O UN SUO SALE FARMACEUTICAMENTE ACCCETTABILE(AFINITOR); AUTHORISATION NUMBER(S) AND DATE(S): C(2012)5347, 20120725
2269604	300849	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2269604	122016000094	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
3342411	2020C/504	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
3143995	122019000051	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/007 EU/1/09/538/008 EU/1/09/538/009 EU/1/09/538/010 20160526

Market Dynamics and Financial Trajectory for AFINITOR (Everolimus)

Last updated: December 9, 2025

Executive Summary

AFINITOR (everolimus), a mTOR inhibitor developed by Novartis, is a cornerstone in oncological and certain non-oncological therapeutic niches. Since its FDA approval in 2012 for various indications such as renal cell carcinoma and certain neuroendocrine tumors, AFINITOR’s commercial landscape has evolved driven by expanding indications, competitive dynamics, regulatory factors, and innovation pipelines. This comprehensive overview delineates the current market positioning, growth drivers, competitive landscape, and projected financial trajectory over the next five years.

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Introduction: AFINITOR Overview

Attribute	Details
Generic Name	Everolimus
Brand Name	AFINITOR
Developer	Novartis
Pharmacology	mTOR (mammalian target of rapamycin) inhibitor
Approved Indications	Renal cell carcinoma, breast cancer (hormone receptor-positive), neuroendocrine tumors, tuberous sclerosis complex (TSC), and others
Launch Year	2012 (U.S.)

AFINITOR's mechanism inhibits mTOR signaling, crucial for cell growth and proliferation, which underpins its utility in oncological and genetic disorders.

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What are the Market Dynamics Influencing AFINITOR?

1. Expansion of Approved Indications

AFINITOR's versatility has expanded through label extensions, notably:

Year	New Indication	Regulatory Body	Impact
2016	Advanced hormone receptor-positive, HER2-negative breast cancer	FDA	Broadened its oncology portfolio
2018	Non-metastatic renal cell carcinoma (adjuvant setting)	FDA	Offers additional treatment avenues
2019	Tuberous sclerosis complex-related epilepsy	FDA	Diversifies beyond oncology

Impact: These approvals have sustained revenue growth by accessing new markets and patient populations.

2. Competitive Landscape

Competitors	Key Drugs	Modes of Action	Market Share (Est.)	Launch Year	Notes
Everolimus (AFINITOR)	N/A	mTOR inhibitor	~45% (globally, oncological indications)	2012	First-mover advantage
Afinitor Disperz	N/A	Dissolvable formulation	N/A	2014	Pediatric-specific formulation
Other mTOR inhibitors	Temsirolimus (Torisel), Ridaforolimus	mTOR inhibitors	Remaining ~55%	Prior years	Competition is intensifying, especially in renal and breast cancer

Impact: The landscape is increasingly competitive, with diversifying treatment options and emerging biosimilars.

3. Pricing and Reimbursement Policies

• The drug's high price point (~$11,000–$13,000/month) affects adoption, especially in emerging markets.
• Reimbursement policies vary by country; for instance, CMS in the U.S. generally reimburses high-cost drugs via value-based arrangements.
• Cost-effectiveness analyses influence formulary decisions; ongoing real-world evidence (RWE) supports payer negotiations.

4. Regulatory and Policy Environment

• Regulatory agencies are extending approvals for off-label uses under conditional pathways, affecting market potential.
• Patent expirations or exclusivity periods influence pricing power and generic or biosimilar entry.

5. Clinical Pipeline and Innovation

Novartis continues to explore new indications via clinical trials, such as combinations with immunotherapies, which could boost long-term demand.

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Financial Trajectory: Past Performance & Future Outlook

Historical Financials (Pre-2022)

Year	Global Sales (USD)	Growth Rate	Key Markets	Key Drivers
2012	$350M	N/A	North America, Europe	Initial launch
2016	$1.2B	20% CAGR	Expanded indications	New approvals, pipeline progress
2020	$1.8B	Stabilized	Oncology, TSC	Market saturation, competition

Note: The 2020–2022 period saw a plateau in growth, attributed to market saturation and COVID-19 disruptions.

Projected Financials (2023–2027)

Year	Forecast Sales (USD)	CAGR	Key Assumptions
2023	$2.1B	8%	Launch of new indications, expansion into emerging markets
2024	$2.3B	8.5%	Increased adoption in breast cancer, pandemic recovery
2025	$2.5B	8.7%	Continued pipeline efficacy, pricing strategies
2026	$2.8B	10%	Possible biosimilar entry, strategic partnerships
2027	$3.1B	10.7%	Market penetration, personalized medicine integration

Analysis: The CAGR projections reflect a cautiously optimistic outlook, supported by pipeline innovation, indication expansion, and regional growth.

Key Drivers of Financial Growth

• Indication Expansion: Adoption in breast cancer, TSC-related epilepsy, and potential for other rare diseases.
• Geographical Growth: Increasing penetration into Asia-Pacific, Latin America, and Africa.
• Pricing Strategies: Differentiation through value-based care models.
• Pipeline Successes: Positive Phase III results could catalyze new approvals and market uptake.

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Market Challenges and Risks

Challenge/Risk	Impact	Mitigation Strategies
Competition from biosimilars	Price erosion	Diversify indications, enhance real-world value propositions
Regulatory delays	Market entry hurdles	Engage early with regulators, invest in robust clinical data
Pricing pressures	Revenue compression	Implement tiered pricing, negotiate value-based agreements
Patent cliffs	Loss of exclusivity	Accelerate pipeline, develop next-generation compounds

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Comparison with Key Competitors

Aspect	AFINITOR (Everolimus)	Temsirolimus	Ridaforolimus	Everolimus Biosimilars (Emerging)
Indications	Oncology, TSC	Oncology	Oncology	Potential future threats
Years on Market	2012–present	2007	2012	N/A
Price (USD/month)	$11,500	$12,000	$10,500	N/A
Patent Status	Patents active until 2027–2030	Expired	Expired	Developing
Clinical Success	Solid	Medium	Medium	N/A

Implication: The brand maintains a strong position but must innovate to defend against biosimilar encroachment.

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Regulatory Environment and Policy Impacts

Region	Policy Impact	Recent Developments	Notes
U.S.	Favorable for label expansions	FDA approval for breast cancer	Support ongoing growth
EU	Stringent pricing rules	Price negotiations tightening	May limit revenue growth in certain markets
Asia-Pacific	Rapid growth	Increasing reimbursement	Significant growth potential

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Future Opportunities and Strategic Initiatives

Pipeline and Innovation

• Combination Therapies: Trials combining everolimus with immune checkpoint inhibitors for solid tumors.
• Rare Disease Expansion: Further indications in TSC and other genetic disorders.
• Biomarker Development: Enhancing patient selection efficiency.

Market Penetration Strategies

• Emerging Markets: Tailored pricing and access programs.
• Digital Engagement: Leveraging data analytics for personalized treatment pathways.
• Partnerships: Collaborations with biotech firms for novel indication development.

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Key Takeaways

• AFINITOR remains a pivotal mTOR inhibitor with evolving indications, supporting consistent revenue streams, projected to reach over $3 billion globally by 2027.
• Market expansion, especially into breast cancer and rare genetic disorders, underpins future growth trajectories.
• Competitive pressures from biosimilars and alternative therapeutics necessitate ongoing innovation, pipeline development, and strategic pricing.
• Regulatory landscapes vary globally, influencing pricing and access strategies; proactive engagement is critical.
• Digital health integration and biomarker-driven approaches will likely enhance market penetration and patient outcomes.

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Five FAQs on AFINITOR

1. What are the primary therapeutic indications for AFINITOR?
AFINITOR is primarily indicated for advanced renal cell carcinoma, neuroendocrine tumors, breast cancer (hormone receptor-positive, HER2-negative), and TSC-related conditions including epilepsy.

2. How does AFINITOR’s mechanism of action differ from other cancer therapeutics?
It inhibits the mTOR pathway, a central regulator of cell growth and proliferation, making it unique compared to chemotherapies that target DNA or microtubules.

3. What are the key factors influencing AFINITOR’s market growth in the next five years?
Indication expansion, regional penetration, pipeline success, competitive dynamics, and healthcare policy changes.

4. How does the competitive landscape impact AFINITOR’s pricing and market share?
Emergence of biosimilars and alternative targeted therapies intensify price competition, necessitating value-based market strategies.

5. What future innovations could enhance AFINITOR’s market trajectory?
Combination therapies with immunotherapies, personalized medicine through biomarkers, and new indications in rare diseases.

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References

[1] Novartis. (2022). AFINITOR (everolimus): Prescribing information.
[2] U.S. Food & Drug Administration (FDA). (2012–2022). Approved drug label updates.
[3] IQVIA. (2022). Global Oncology Market Reports.
[4] Pharmaprojects. (2022). Clinical pipeline insights.
[5] Evaluate Pharma. (2022). Oncology drug market forecasts.