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. Eleven 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:	38
Clinical Trials:	181
Patent Applications:	4,495
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
Fudan University	Phase 3
Nationwide Children's Hospital	Phase 2
Stemline Therapeutics, Inc.	Phase 1/Phase 2

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
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012	AB	RX	Yes	No					Y

Expired US Patents for AFINITOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	022334-004	Mar 30, 2012
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012

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/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 AFINITOR

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1281400
Taiwan	I270550
Portugal	2269603
Japan	2020143134	癌の処置 (CANCER TREATMENT)
New Zealand	313633	PHARMACEUTICAL COMPOSITION CONTAINING RAPAMYCIN IN A SOLID DISPERSION WITH A CARRIER MEDIUM
Russian Federation	2483727	ПРИМЕНЕНИЕ ПРОИЗВОДНОГО РАПАМИЦИНА (USE OF RAPAMYCIN DERIVATIVE)
Cyprus	2125	O-alkylated rapamycin derivatives and their use particularly as immunosuppressants

Supplementary Protection Certificates for AFINITOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663916	04C0012	France		PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: NL 29433 20040415; FIRST REGISTRATION: SE - 18693 20030718
3143995	C03143995/01	Switzerland		PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 14.11.2016
3143995	300992	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2269604	CA 2016 00060	Denmark		PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-006 20090805
2269604	300849	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
0663916	SZ 14/2004	Austria		PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN)
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

AFINITOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Afinitor

Market Overview

The Afinitor drug market, centered around the medication everolimus, is a significant segment within the pharmaceutical industry, particularly in oncology. Afinitor is used to treat various types of cancer, including advanced renal cell carcinoma, pancreatic neuroendocrine tumors, and hormone receptor-positive advanced breast cancer[1].

Market Size and Growth Projections

As of 2023, the global Afinitor drug market was valued at approximately $767.7 million. It is projected to reach $1.046 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.8% during the forecast period[1][4].

Key Drivers

Several factors drive the growth of the Afinitor drug market:

Increasing Prevalence of Cancer

The rising incidence of cancer worldwide is a primary driver, as it increases the demand for effective oncology treatments like Afinitor[1].

Ongoing Clinical Trials

Clinical trials exploring new therapeutic indications for Afinitor expand its potential applications, contributing to market growth[1].

Advancements in Drug Delivery

Technological advancements in drug delivery mechanisms and formulations enhance the efficacy and safety profile of Afinitor, boosting its adoption[1].

Research and Development Investments

Substantial investments in research and development by pharmaceutical companies drive innovation, leading to the introduction of novel treatment options and formulations[1].

Regulatory Approvals

Regulatory approvals for expanded indications further boost market prospects by allowing Afinitor to be used in a broader range of treatments[1].

Regional Snapshot

The market dynamics vary significantly across different regions:

North America

North America dominates the market due to its well-established healthcare infrastructure, high prevalence of cancer, and early adoption of advanced therapeutics. Significant investments in research and development activities in this region contribute to the introduction of novel treatment options[1].

Europe

Europe follows closely, driven by supportive government initiatives, increasing healthcare expenditure, and a robust regulatory framework. These factors create a favorable environment for the adoption of Afinitor[1].

Asia Pacific

The Asia Pacific region is emerging as a lucrative market, fueled by a large patient pool, improving access to healthcare services, and rising awareness about cancer treatment options. Strategic collaborations between pharmaceutical companies and local healthcare providers enhance market penetration in this region[1].

Competitive Landscape

The Afinitor drug market is characterized by strategic collaborations and partnerships:

Key Players

Novartis and Breckenridge are among the main players in the Afinitor drug market. These companies engage in various strategic initiatives to expand their market share and innovate in drug delivery and formulations[4].

Market Strategies

The competitive landscape sees a focus on patient-centric approaches, driving innovation and market penetration. Companies invest in research and development to develop new formulations and combination therapies, further expanding the market potential[1].

Financial Performance

Revenue and Sales

Afinitor has consistently shown strong financial performance. For instance, in the third quarter of 2011, Afinitor sales were $118 million, representing a 69% increase in constant currencies, highlighting its significant role in oncology sales[5].

Net Sales and Operating Income

Novartis, the primary manufacturer of Afinitor, has reported substantial net sales and operating income. For example, in the fourth quarter of 2022, Novartis's core operating income was $4.0 billion, with a core operating income margin of 31.8% of net sales[2].

Restraints and Challenges

Despite the positive outlook, the Afinitor drug market faces several challenges:

High Cost

The high cost associated with Afinitor therapy limits its accessibility, particularly in developing regions with constrained healthcare budgets[1].

Alternative Treatments and Generic Competition

The presence of alternative treatment options and emerging generic competition poses a threat to market share, leading to pricing pressures and reduced profit margins for manufacturers[1].

Opportunities for Growth

The market presents several opportunities for expansion:

Increasing Incidence of Cancer

The rising incidence of cancer worldwide, coupled with an aging population and lifestyle factors, provides a vast patient pool for Afinitor therapy[1].

Precision Medicine and Biomarker-Driven Approaches

Advancements in precision medicine and biomarker-driven approaches offer opportunities for personalized treatment regimens, optimizing therapeutic outcomes for patients receiving Afinitor[1].

Emerging Markets

The untapped potential of emerging markets in Asia, Latin America, and Africa presents opportunities for market penetration and revenue growth. Advancements in healthcare infrastructure and supportive government initiatives in these regions create a conducive environment for market expansion[1].

Technological Advancements

Technological advancements play a crucial role in the Afinitor drug market:

Drug Delivery Mechanisms

Improvements in drug delivery mechanisms and formulations enhance the efficacy and safety profile of Afinitor, making it more appealing to healthcare providers and patients[1].

Innovation in Treatment Options

Strategic collaborations and partnerships between pharmaceutical companies and research institutions facilitate the development of innovative formulations and combination therapies, further expanding the market potential[1].

Regulatory Environment

Favorable government regulations and initiatives aimed at improving access to cancer care and promoting early diagnosis and treatment are pivotal in fostering market growth:

Expanded Indications

Regulatory approvals for expanded indications of Afinitor boost market prospects by allowing the drug to be used in a broader range of treatments[1].

Supportive Government Initiatives

Government initiatives aimed at improving healthcare infrastructure and reducing treatment costs create a supportive environment for the adoption of Afinitor[1].

Key Takeaways

• Increasing Cancer Prevalence: Drives demand for Afinitor.
• Ongoing Clinical Trials: Explores new indications for Afinitor.
• Research and Development: Fuels market expansion.
• Technological Advancements: Enhances drug delivery mechanisms.
• Rising Healthcare Expenditure: Supports market growth.
• Competitive Landscape: Sees strategic collaborations and partnerships.
• Regulatory Approvals: Boosts market prospects.
• Patient-Centric Approaches: Drives innovation and market penetration.

FAQs

Q: What is the projected market size of the Afinitor drug market by 2030? A: The global Afinitor drug market is projected to reach $1.046 billion by 2030[1].

Q: What is the primary driver of the Afinitor drug market? A: The increasing prevalence of cancer worldwide is a significant driver of the Afinitor drug market[1].

Q: Which regions dominate the Afinitor drug market? A: North America and Europe dominate the market, with the Asia Pacific region emerging as a lucrative market[1].

Q: What are the main challenges facing the Afinitor drug market? A: High cost, alternative treatment options, and emerging generic competition are significant challenges[1].

Q: What opportunities exist for the growth of the Afinitor drug market? A: Opportunities include increasing cancer incidence, advancements in precision medicine, and untapped potential in emerging markets[1].

Sources

1. PharmiWeb: Afinitor Drug Market is Projected to Reach USD 1046 Mn by 2030 with CAGR of 4.8%...
2. Novartis: Novartis Financial Results Q4 2022 – English
3. Cognitive Market Research: Afinitor Drug Market Report 2024 (Global Edition)
4. Valuates Reports: Afinitor Drug - Global Market Share and Ranking, Overall Sales and ...
5. Fierce Biotech: Novartis achieves strong third quarter financial performance and pipeline progress