EVEROLIMUS - Generic Drug Details

What are the generic 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, Mylan, Natco, Novartis, Alkem Labs Ltd, Biocon Pharma, Breckenridge, Hikma, Novugen, Ph Health, and Teva Pharms Usa, and is included in eighteen 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. Twelve suppliers are listed for this compound.

Summary for EVEROLIMUS

International Patents:	229
US Patents:	2
Tradenames:	4
Applicants:	12
NDAs:	18
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	817
Patent Applications:	8,609
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
Boston Children's Hospital	PHASE2
University of Maryland, Baltimore	PHASE1
University of Texas Southwestern Medical Center	PHASE1

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
Ph Health	EVEROLIMUS	everolimus	TABLET;ORAL	207934-002	Dec 9, 2019	AB	RX	No	No
Ph Health	EVEROLIMUS	everolimus	TABLET;ORAL	205775-003	Oct 18, 2021	AB	RX	No	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No	9,006,224
Novugen	EVEROLIMUS	everolimus	TABLET;ORAL	219955-004	Oct 30, 2025	AB	RX	No	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	AB	RX	Yes	Yes	9,006,224
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-002	Apr 20, 2010	AB	RX	Yes	No

Expired US Patents for EVEROLIMUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010	6,455,518*PED
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012	8,778,962*PED
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012	8,436,010*PED
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012	8,778,962*PED
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	6,004,973*PED
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	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
Spain	2728739
Spain	2629317
Norway	334646
South Korea	20050095906
Japan	6349474
Russian Federation	2008124827	ЛЕЧЕНИЕ НЕЙРОЭНДОКРИННЫХ ОПУХОЛЕЙ

Supplementary Protection Certificates for EVEROLIMUS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2269603	122015000094	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 20120723
2269603	92880	Luxembourg		PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE (AFINITOR); AUTHORISATION NUMBER AND DATE: EU/1/09/538/001,003,004 ET 006-010 - AFINITOR
3143995	300992	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2269603	CA 2015 00058	Denmark		PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
3143995	2019C/528	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
3342411	LUC00148	Luxembourg		PRODUCT NAME: EVEROLIMUS; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001-008 20110830

Market Dynamics and Financial Trajectory for Everolimus

Last updated: July 27, 2025

Introduction

Everolimus, marketed under the brand name Afinitor among others, is a mTOR (mammalian target of rapamycin) inhibitor with a broad spectrum of applications, primarily in oncology, transplant rejection, and certain rare diseases. Its development and commercialization have transformed treatment paradigms and generated substantial financial interest within the pharmaceutical industry. This article analyzes the current market dynamics and financial trajectory of everolimus, offering insights crucial for stakeholders, including investors, healthcare providers, and strategic planners.

Pharmacological Profile and Therapeutic Indications

Everolimus's mechanism as an mTOR inhibitor underpins its versatility in multiple therapeutic areas. Initially approved for kidney transplantation to prevent rejection, its indications have expanded to include various cancers such as advanced renal cell carcinoma, neuroendocrine tumors, and breast cancer, as well as rare diseases like tuberous sclerosis complex (TSC) with subependymal giant cell astrocytoma (SEGA) [1].

The drug's targeted approach fills unmet needs, especially in oncology, where resistance to traditional chemotherapies remains a challenge. Its efficacy in suppressing tumor growth by inhibiting angiogenesis and cellular proliferation has been validated through numerous clinical trials, fueling its global adoption.

Market Landscape and Competitive Positioning

The everolimus market landscape is characterized by a competitive array of targeted cancer therapies, immunosuppressants, and novel biological agents. Key players include Novartis (the original manufacturer), Pfizer, and generic pharmaceutical firms entering biosimilar markets.

Novartis's strategic patent protections and regulatory approvals in key regions have sustained its dominant market share. However, patent expirations, especially in emerging markets, have prompted an influx of generics and biosimilars, exerting downward pressure on prices. The entry of biosimilars, such as Emgality (a biologic akin to subsequent formulations), is further intensifying competitive dynamics.

In oncology, everolimus contends with agents like sunitinib, temsirolimus, and newer targeted therapies. Its positioning hinges on proven efficacy, manageable safety profiles, and the expanding use in combination regimens.

Regulatory and Patent Trends

Patent expiration timelines significantly influence market dynamics. Novartis's key patents for Afinitor in the U.S. and Europe are set to expire within the next five years, opening avenues for generic competition. Consequently, the company has implemented strategies like patent extensions and supplemental indications to prolong exclusivity and market appeal [2].

Regulatory trends favor broader approval for novel indications, often driven by fast-track or orphan drug designations, which can extend market protection and incentivize investment.

Market Drivers

Several factors propel everolimus's market growth:

• Expanded Indications: Increasing approvals for multiple cancers and TSC expand market share.

• Unmet Clinical Needs: Resistance to existing therapies and aggressive tumor profiles sustain demand.

• Orphan Drug Status: Certain indications benefit from orphan drug incentives, boosting research and commercialization.

• Rising Global Burden of Cancer: The increasing incidence of cancers and chronic diseases worldwide creates a growing patient population.

• Advancements in Personalized Medicine: Biomarker-driven treatments enhance efficacy and adoption.

Market Challenges

Despite promising prospects, several challenges temper growth:

• Pricing and Reimbursement Pressures: Cost containment initiatives in healthcare systems, especially in Europe and Asia, limit profitability.

• Patent Cliffs: Expiry of key patents invites competition and generic entry, eroding revenue.

• Side Effect Profile: Adverse effects including stomatitis and pulmonary toxicity can restrict use, especially in vulnerable populations.

• Market Saturation in Established Regions: Mature markets experience slower growth, prompting a focus on emerging regions.

Financial Trajectory and Revenue Forecasts

Historically, everolimus has demonstrated robust sales figures. Novartis reported annual sales approximating $1.5 billion globally for Afinitor in 2019 [3]. Post-patent expiration, the revenue trajectory is expected to decline due to generic competition, with estimations projecting a 20-30% sales decrease over the next 2-3 years in mature markets.

However, forecast models predict stabilization through:

• Expansion into Emerging Markets: Increasing access and regulatory approvals in countries like China, India, and Brazil.

• Additional Indications: Ongoing clinical trials exploring its utility in indications such as hepatocellular carcinoma, which can boost future revenues.

• Combination Therapy Use: Prescribing alongside other targeted therapies augments patient outcomes, fostering sustained demand.

Projections suggest that, despite near-term declines, enhanced geographic penetration and label extensions could maintain annual revenues near $1 billion by 2025.

Pricing Strategies and Market Penetration

Pricing strategies adapt to regional economic environments. High-income markets maintain premium pricing, justified by clinical benefits and reimbursement negotiations. Developing country markets often rely on biosimilars and negotiated discounts, affecting overall profitability.

Market penetration is also influenced by payers' reimbursement policies, which are increasingly scrutinizing the cost-effectiveness of targeted therapies. Cost-utility analyses often favor unchanged or slightly reduced prices in competitive environments, especially post-patent expiry.

Pipeline and Future Outlook

Furthermore, everolimus's pipeline includes investigational uses in autoimmune diseases, neurodegeneration, and resistant cancers. Positive trial outcomes could facilitate label extensions, providing new revenue streams.

In parallel, the rise of alternative mTOR inhibitors and novel targeted agents necessitates strategic positioning. Companies are investing in combination therapies and biomarker-guided trials to differentiate and sustain revenue.

Regulatory and Market Entry Considerations

Entering markets with high unmet need and less restrictive regulatory pathways offers lucrative opportunities. China's burgeoning biotech sector and India's expanding healthcare infrastructure serve as strategic expansion zones.

Intellectual property strategies, including patent filings and manufacturing exclusivities, remain critical to safeguarding future revenues amid increasing biosimilar competition.

Conclusion

Everolimus's market dynamics are marked by a shift from monoclonal exclusivity toward intensified competition from generics, regional expansion, and therapeutic innovation. Its financial future hinges on patent management, ongoing indication approvals, and geographic penetration, especially in emerging economies. Stakeholders must navigate pricing pressures, regulatory landscapes, and pipeline developments to optimize value extraction.

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Key Takeaways

• Market Maturity and Patent Cliffs: Patent expirations will likely lead to revenue erosion in mature markets, emphasizing the importance of pipeline growth and geographic expansion.

• Strategic Diversification: Securing new indications and combination regimens can sustain sales and broaden clinical utility.

• Emerging Markets as Growth Avenues: Rapid healthcare infrastructure development and unmet needs present opportunities for growth outside traditional markets.

• Pricing and Reimbursement Strategies: Flexibility in pricing, especially in cost-sensitive regions, will be vital for maintaining market share.

• Pipeline and Innovation Focus: Investing in clinical trials for novel indications and combination therapies can future-proof revenue streams.

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FAQs

1. When do key patents for everolimus expire, and what impact will this have on the market?
Most primary patents for Afinitor are set to expire within the next 3-5 years, potentially leading to increased generic competition and reduced pricing, impacting revenue primarily in established markets.

2. What are the primary therapeutic areas driving everolimus sales?
Oncology (renal cell carcinoma, neuroendocrine tumors, breast cancer), transplantation (preventing rejection), and rare diseases like tuberous sclerosis complex are the main drivers.

3. How are biosimilars affecting the future of everolimus?
Biosimilars and generics are expected to reduce prices and market share after patent expiry, especially in mature markets, but innovation and expanded indications can mitigate impacts.

4. What regions offer the most growth potential for everolimus?
Emerging markets in Asia, Latin America, and Africa represent significant growth opportunities due to expanding healthcare infrastructure and unmet medical needs.

5. What strategic measures can companies adopt to maximize revenue from everolimus?
Diversification into new indications, geographic expansion, strategic patent management, and development of combination therapies are critical to sustaining profitability.

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References:
[1] Novartis. Everolimus (Afinitor) Summary of Product Characteristics.
[2] U.S. Patent and Trademark Office. Patent expiration timelines for Afinitor.
[3] Novartis Annual Report 2019.