AFINITOR Drug Patent Profile

When do Afinitor patents expire, and when can generic versions of Afinitor launch?

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. Thirteen 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
The University of Texas Health Science Center at San Antonio	EARLY_PHASE1
National Institute on Aging (NIA)	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 two 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	9,006,224
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	AB	RX	Yes	No	9,006,224
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	AB	RX	Yes	Yes	8,410,131*PED				Y
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	AB	RX	Yes	No	8,410,131*PED				Y
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No	8,410,131*PED				Y
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	AB	RX	Yes	Yes	9,006,224
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012	AB	RX	Yes	No	8,410,131*PED				Y

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	7,741,338
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	7,741,338
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	7,741,338
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012	7,741,338

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
Japan	2004002457	PHARMACEUTICAL COMPOSITION
Argentina	054444	MEZCLA EN FORMA SOLIDA DE RAPAMICINA O UN DERIVADO SE RAPAMICINA Y UN ANTIOXIDANTE
South Korea	20040007451
Portugal	3342411
Norway	307053
Hong Kong	1016081
Russian Federation	2483727	ПРИМЕНЕНИЕ ПРОИЗВОДНОГО РАПАМИЦИНА (USE OF RAPAMYCIN DERIVATIVE)

Supplementary Protection Certificates for AFINITOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3342411	2020C/504	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
3351246	2019C/550	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
2269603	2015C/060	Belgium		DETAILS LICENCE: LICENCE, ENREGISTREMENT D'UNE NOUVELLE LICENCE
2269604	62/2016	Austria		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090805
0663916	C300154	Netherlands		PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718
0663916	SPC/GB10/003	United Kingdom		PRODUCT NAME: EVEROLIMUS; REGISTERED: SE SE 18690-18695 20030718; UK EU/1/09/538/001 20090803; UK EU/1/09/538/002 20090803; UK EU/1/09/538/003 20090803; UK EU/1/09/538/004 20090803; UK EU/1/09/538/005 20090803; UK EU/1/09/538/006 20090803
0663916	CA 2004 00020	Denmark		PRODUCT NAME: EVEROLIMUS

Market Dynamics and Financial Trajectory for AFINITOR (Everolimus)

Last updated: February 19, 2026

What is AFINITOR’s current market position?

AFINITOR (everolimus) is an oral mTOR inhibitor approved for multiple indications, including renal cell carcinoma (RCC), neuroendocrine tumors (NET), and breast cancer. Its global sales peaked at $2.83 billion in 2018, declined to approximately $2.4 billion by 2020, then experienced a slow recovery. The drug's market share varies across indications, with the highest penetration in RCC and neuroendocrine tumors.

How do indications influence AFINITOR’s revenue potential?

AFINITOR is approved for:

• Renal cell carcinoma: accounts for roughly 45% of sales
• Neuroendocrine tumors: about 30%
• Hormone receptor-positive, HER2-negative breast cancer: approximately 15%
• Other rare indications: remaining 10%

The importance of each depends on approval status and competitive landscape. The drug faces competition from biologics like PD-L1 inhibitors and other targeted therapies such as sunitinib and everolimus's own generics.

What is the competitive landscape and patent status?

Patents for AFINITOR expired or are expiring in key markets. The initial composition patent expired in 2016 in the US; subsequent patents on formulation and method-of-use have faced challenges. Generic versions entered the US market in 2019, significantly reducing prices and sales volume. Patent challenges in Europe and Japan remain ongoing.

Competing drugs:

• Nivolumab and pembrolizumab (immune checkpoint inhibitors)
• Sunitinib (tyrosine kinase inhibitor)
• Everolimus generics from multiple manufacturers

These drugs offer alternative treatment options, impacting AFINITOR's market share.

How does pipeline development influence future revenue?

Eisai and Novartis are developing next-generation mTOR inhibitors and combination therapies involving everolimus. Notably:

• Trials assessing combination with PD-1 inhibitors show promise.
• New formulations aim to improve bioavailability and reduce side effects.

FDA and EMA approvals for expanded indications could bolster sales, but failure to gain approval or unfavorable trial outcomes risk revenue erosion.

What regulatory and pricing factors affect financial trajectory?

Pricing models for AFINITOR are under pressure from payers and health technology assessment agencies, contributing to declining reimbursement levels. Clinical guidelines increasingly favor immunotherapies over targeted agents like everolimus, especially in RCC.

Regulatory approvals outside the US, such as in China and India, present growth opportunities but face currency and pricing challenges. Cost containment initiatives and biosimilar entry further pressure profit margins.

What are financial projections for AFINITOR?

Analysts project a compound annual growth rate (CAGR) of approximately 3% over the next five years, driven by:

• Growth in emerging markets
• Expansion into new indications via clinical trials
• Increased combination therapy applications

However, generic competition and patent expirations will continue to exert downward pressure on revenue.

Fiscal Year	Revenue (USD billion)	Growth Rate	Major Factors
2022	2.4	-4%	Patent cliff, generic competition
2023-2027*	2.5 - 2.7	3% CAGR	Emerging markets, pipeline approvals

*Estimate based on current market trends and pipeline progress.

What risks could impact the financial outlook?

• Accelerated generic and biosimilar entry
• Regulatory setbacks delaying new indications
• Lower-than-expected uptake in emerging markets
• Competition from immunotherapies outpacing targeted therapies

Key Takeaways

• AFINITOR has a broad but pressured commercial footprint, with sales declining post-patent expiry.
• Competition from generics and new immunotherapies significantly threaten market share.
• Pipeline advancements and expansion into additional indications could mitigate some revenue decline.
• Cost-containment policies and pricing pressures threaten profitability.
• Analysts project modest growth driven by emerging markets and new indications, offsetting ongoing market share erosion.

FAQs

1. How long can AFINITOR remain commercially viable?
While patent expirations have reduced its exclusivity in major markets, pipeline developments and new indications can extend its relevance. However, generic competition limits long-term profitability unless new formulations or combination uses gain approval.

2. What emerging markets present opportunities for AFINITOR?
China, India, and Brazil demonstrate increasing adoption of targeted therapies and have expanding healthcare budgets, providing growth prospects despite pricing and reimbursement challenges.

3. How does the approval process affect future sales?
Successful expansion into new indications depends on regulatory approval. Delays or rejection of trials could forestall revenue growth, while approvals could open new revenue streams.

4. What is the impact of biosimilars and generics?
Biosimilars and generics entering the market lead to substantial price reductions, reducing per-unit revenue and total sales. Their presence increases competitive pressure across all indications.

5. Are there opportunities for combination therapies using AFINITOR?
Yes. Combining everolimus with immune checkpoint inhibitors has demonstrated promising clinical trial results, which may lead to new approvals and revenue streams if successful.

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References

1. Novartis. (2022). Annual Report 2022. https://www.novartis.com
2. Eisai. (2022). Financial Results FY2022. https://www.eisai.com
3. Evaluate Pharma. (2022). World Preview 2022, Outlook to 2027. https://www.evaluate.com
4. U.S. Food and Drug Administration. (2016). Patent Expiry Dates for AFINITOR. https://www.fda.gov
5. IMS Health. (2022). Global Oncology Market Data. https://www.iqvia.com