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, Mylan, Natco, Novartis, Alkem Labs Ltd, Biocon Pharma, Breckenridge, Endo Operations, Hikma, and Teva Pharms Usa, and is included in seventeen 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:	11
NDAs:	17
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	779
Patent Applications:	6,571
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
Stanford University	Phase 1/Phase 2
Central Hospital, Nancy, France	Phase 2
Pfizer	Phase 3

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	207486-002	Jun 8, 2020	AB	RX	No	No
Amneal	EVEROLIMUS	everolimus	TABLET, FOR SUSPENSION;ORAL	218863-003	Jan 10, 2025	AB	RX	No	No
Endo Operations	EVEROLIMUS	everolimus	TABLET;ORAL	207934-004	Dec 9, 2020	AB	RX	No	No
Endo Operations	EVEROLIMUS	everolimus	TABLET;ORAL	205775-001	Oct 18, 2021	AB	RX	No	No

Expired US Patents for everolimus

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	Apr 20, 2010
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010

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/001038 Hormone-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/002311 Renal 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
Russian Federation	2325906	ЛЕЧЕНИЕ РАКА (CANCER MEDICAL TREATMENT)
Lithuania	PA2019521
Poland	231418
Luxembourg	C00122

Supplementary Protection Certificates for everolimus

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663916	122004000033	Germany		PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: 58387.00.00 58387.00.01 58387.01.00 58387.01.01 58387.02.00 58387.03.00 20040204 FIRST REGISTRATION: SCHWEDEN 18690 18691 18692 18693 18694 18695 20030718
3143995	C03143995/01	Switzerland		PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 14.11.2016
3342411	CA 2020 00007	Denmark		PRODUCT NAME: EVEROLIMUS; REG. NO/DATE: EU/1/09/538 (K(2011)6162) 20110830
2269604	132016000127697	Italy		PRODUCT NAME: EVEROLIMUS O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AFINITOR); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/09/538/001-006, 20090805

Market Dynamics and Financial Trajectory for Everolimus

Introduction to Everolimus

Everolimus, a derivative of sirolimus, is a potent immunosuppressive agent and antiproliferative drug used in the treatment of various cancers and to prevent organ rejection in transplant patients. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare providers.

Global Everolimus Market Size and Forecast

The global Everolimus market has been growing at a moderate pace over the last few years. Despite some fluctuations, the market is expected to see significant growth in the forecasted period from 2024 to 2030. However, there is a notable adjustment in the forecasted market size, with estimates suggesting a readjusted size of US$ 255.2 million by 2030, down from US$ 512 million in 2023, reflecting a CAGR of -7.6% during the forecast period[4].

Market Drivers

Several factors drive the growth of the Everolimus market:

Rising Cancer Incidence

The increasing global incidence of cancer, particularly renal cell carcinoma, pancreatic neuroendocrine tumors, and breast cancer, drives the demand for efficient therapies like Everolimus[1].

Growing Applications

Ongoing research into the effectiveness of Everolimus in treating novel forms of cancer and other illnesses expands its commercial potential. Its use in conjunction with other targeted treatments further increases its market reach[1].

Developments in Personalised Medicine

The growing popularity of personalised medicine, where medications like Everolimus target specific biochemical pathways in cancer cells, enhances its significance and market demand[1].

Expanding Transplant Procedures

The increasing number of global organ transplant procedures drives the demand for immunosuppressive medications like Everolimus to prevent organ rejection[1].

FDA Approvals and Clinical Trials

Expanded approved uses and ongoing clinical trials providing efficacious evidence, along with regulatory approvals for additional indications, help drive market expansion[1].

Growing Healthcare Spending

Increased focus on healthcare and rising healthcare spending globally enable patients to access expensive drugs like Everolimus, propelling market growth[1].

Developing Markets

Improving healthcare access and the rising prevalence of cancer in developing nations contribute to the geographic expansion of the Everolimus market[1].

Technological Developments

Advancements in drug delivery methods and formulations can enhance the efficacy and safety profile of Everolimus, appealing to both patients and healthcare professionals[1].

Market Restraints

Despite the growth drivers, several factors act as restraints to the Everolimus market:

Patent Expiration

The expiration of patents protecting Everolimus could lead to generic competition, significantly reducing the original manufacturer’s market share and earnings[1].

Regulatory Obstacles

Tight regulations requiring approval and post-marketing monitoring can impede market expansion. Regulatory barriers in different regions can also delay market introduction or growth[1].

High Cost

The high cost of Everolimus, similar to other targeted treatments, can make it unaffordable for patients, especially in areas with limited healthcare resources or strict reimbursement guidelines[1].

Competition

The presence of similar medications treating the same indications as Everolimus can impact its sales and market share. New competitors or developments in complementary therapies also pose a threat[1].

Adverse Effects

Serious side effects or safety issues associated with Everolimus can restrict its use or lead to patients discontinuing treatment, affecting consumer demand[1].

Generic Competition

If Everolimus’s patent is revoked, generic versions could become available, reducing the original manufacturer’s profit margin and eroding its price[1].

Clinical Trial Failures

Failures in clinical trials can also hinder market growth by reducing confidence in the drug’s efficacy and safety[1].

Regional Market Dynamics

The Everolimus market varies significantly across different regions:

North America

This region is a significant market for Everolimus, driven by a high prevalence of cancer and advanced healthcare infrastructure. Major pharmaceutical companies in the region also contribute to market growth[1].

Europe

Europe has a strong demand for Everolimus due to its well-established healthcare system and high incidence of cancer and organ transplants. Regulatory approvals and reimbursement policies influence market dynamics in various European countries[1].

Asia-Pacific

The market in this region is growing rapidly, fueled by increasing cancer rates, improving healthcare facilities, and rising awareness about advanced treatment options. Countries like China, India, and Japan are major contributors to market growth[1].

Latin America

This region is experiencing growth in the Everolimus market due to improving healthcare access and rising prevalence of chronic diseases. However, economic challenges and healthcare disparities can affect market penetration[1].

Middle East & Africa

The market in this region is emerging, with increasing investments in healthcare infrastructure and rising awareness about cancer treatment and organ transplantation. However, access to advanced medications can be limited in some areas[1].

Key Players

Several key players dominate the Everolimus market:

• Novartis Inc.: The primary manufacturer of Everolimus, known by the brand name Afinitor.
• Biocon Inc.
• Breckenridge Pharmaceuticals Inc.
• Teva Pharmaceuticals USA
• Glenmark Pharmaceuticals Ltd.
• Viatris Inc.
• Transopharm
• Tecoland Corporation
• Gonane Pharma
• Brawn Laboratories Ltd.
• Bright Gene Bio-Medical Technology
• Cipla
• Concord Biotech[1].

Financial Impact and Budget Analysis

Budget Impact Analysis

Studies have shown that the introduction of Everolimus can lead to increased pharmacy costs, but these costs are partially offset by reduced medical service costs. For example, in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) advanced breast cancer, the total budget impact for the first year post-Everolimus entry was estimated to be modest, around $0.044 per member per month (PMPM)[3].

Cost Considerations

The high cost of Everolimus is a significant factor affecting its adoption. However, the overall budget impact remains manageable, especially when considering the reduced medical service costs associated with its use. In the treatment of progressive, well-differentiated non-functional neuroendocrine tumors, the total budget impact ranged from $0.0568 to $0.1443 per member per month (PMPM) in the first through third year after FDA approval[5].

Key Takeaways

• Market Growth: The Everolimus market is expected to grow significantly despite a readjusted forecast size.
• Drivers: Rising cancer incidence, growing applications, developments in personalised medicine, and expanding transplant procedures drive market growth.
• Restraints: Patent expiration, regulatory obstacles, high cost, competition, adverse effects, and generic competition are key restraints.
• Regional Dynamics: North America, Europe, and Asia-Pacific are significant markets, with emerging markets in Latin America and the Middle East & Africa.
• Financial Impact: Increased pharmacy costs are partially offset by reduced medical service costs, making the overall budget impact manageable.

FAQs

Q: What are the primary drivers of the Everolimus market?

A: The primary drivers include rising cancer incidence, growing applications, developments in personalised medicine, expanding transplant procedures, FDA approvals, and growing healthcare spending.

Q: How does the expiration of patents affect the Everolimus market?

A: Patent expiration can lead to generic competition, significantly reducing the original manufacturer’s market share and earnings.

Q: What regions are key markets for Everolimus?

A: North America, Europe, and Asia-Pacific are significant markets, with emerging markets in Latin America and the Middle East & Africa.

Q: How does Everolimus impact healthcare budgets?

A: Everolimus introduction can lead to increased pharmacy costs, but these are partially offset by reduced medical service costs, resulting in a modest overall budget impact.

Q: Who are the main players in the Everolimus market?

A: Key players include Novartis Inc., Biocon Inc., Breckenridge Pharmaceuticals Inc., Teva Pharmaceuticals USA, and others.

Sources

1. Verified Market Research: Everolimus Market Size, & Forecast.
2. Vertex Pharmaceuticals: Third-Quarter 2017 Financial Results.
3. PubMed: Budget impact analysis of everolimus for the treatment of HR+, HER2- ABC.
4. Valuates Reports: Global Everolimus Market Report.
5. Analysis Group: Budget impact of everolimus for the treatment of progressive, well-differentiated non-functional neuroendocrine tumors.

Last updated: 2024-12-16