AFINITOR DISPERZ Drug Patent Profile

Which patents cover Afinitor Disperz, and when can generic versions of Afinitor Disperz launch?

Afinitor Disperz is a drug marketed by Novartis Pharm and is included in one NDA.

The generic ingredient in AFINITOR DISPERZ 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 Disperz

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

Summary for AFINITOR DISPERZ

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1
Drug Prices:	Drug price information for AFINITOR DISPERZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AFINITOR DISPERZ
DailyMed Link:	AFINITOR DISPERZ at DailyMed

See drug prices for AFINITOR DISPERZ

Recent Clinical Trials for AFINITOR DISPERZ

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 3

See all AFINITOR DISPERZ clinical trials

Pharmacology for AFINITOR DISPERZ

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 DISPERZ

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

US Patents and Regulatory Information for AFINITOR DISPERZ

AFINITOR DISPERZ is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012	AB	RX	Yes	No
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012	AB	RX	Yes	No
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012	AB	RX	Yes	Yes

Expired US Patents for AFINITOR DISPERZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012

EU/EMA Drug Approvals for AFINITOR DISPERZ

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 DISPERZ

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

Country	Patent Number	Title	Estimated Expiration
Australia	676198
Lithuania	PA2020503
Cyprus	1121715
China	1911230
Japan	2004525899
Hong Kong	1146245
Norway	340553

Supplementary Protection Certificates for AFINITOR DISPERZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663916	SZ 14/2004	Austria		PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN)
2269604	C02269604/01	Switzerland		PRODUCT NAME: EVEROLIMUS (40-O-(2-HYDROXYETHYL)-RAPAMYCIN); REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 59174 17.11.2009
2269604	93320	Luxembourg		PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538-001-006 - AFINITOR - EVEROLIMUS
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	62/2016	Austria		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090805
2269603	122015000094	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 20120723
3342411	LUC00148	Luxembourg		PRODUCT NAME: EVEROLIMUS; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001-008 20110830

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AFINITOR DISPERZ

Last updated: July 3, 2025

Introduction

In the competitive landscape of oncology and rare disease treatments, AFINITOR DISPERZ stands out as a critical asset for Novartis. This dispersible tablet formulation of everolimus targets specific tumors associated with tuberous sclerosis complex (TSC), including subependymal giant cell astrocytoma (SEGA). As business professionals navigate pharmaceutical investments, understanding its market dynamics and financial trajectory provides actionable insights into growth opportunities and risks. This analysis delves into current trends, competitive pressures, and revenue projections, drawing on available data to inform strategic decisions.

Overview of AFINITOR DISPERZ

AFINITOR DISPERZ represents a targeted therapy innovation from Novartis, approved by the U.S. Food and Drug Administration (FDA) in 2012 for TSC-related SEGA in pediatric patients. As an mTOR inhibitor, it works by blocking proteins that promote tumor growth, offering a lifeline for patients with rare conditions. The drug's dispersible form enhances bioavailability, making it easier to administer, particularly for children and those with swallowing difficulties.

Globally, AFINITOR DISPERZ has secured orphan drug designation in the U.S. and Europe, granting market exclusivity that shields it from generics until patent expirations. Its primary indications include TSC-associated SEGA and renal angiomyolipoma, with off-label uses in other mTOR-driven cancers. Sales peaked in the mid-2010s as part of Novartis's broader oncology portfolio, but evolving generics and biosimilars now challenge its dominance. This positions AFINITOR DISPERZ as a case study in balancing innovation with market sustainability.

Market Dynamics

Market Size and Growth

The global market for mTOR inhibitors, including AFINITOR DISPERZ, reached approximately $3.5 billion in 2023, with projections to grow at a compound annual growth rate (CAGR) of 7% through 2030, according to industry reports [1]. AFINITOR DISPERZ captures a niche within this, primarily in rare disease segments where demand stems from unmet needs in pediatric oncology. In the U.S., annual prescriptions for TSC-related treatments exceed 5,000, driven by increasing awareness and genetic testing advancements.

Growth factors include rising TSC prevalence, estimated at 1 in 6,000 births worldwide, and expanded access in emerging markets like China and India [2]. However, supply chain disruptions and pricing pressures from payers have tempered expansion. For instance, U.S. Medicare negotiations reduced reimbursement rates by 10% in 2023, impacting accessibility. Competitors like Pfizer's Vizimpro and emerging biologics from smaller biotech firms intensify rivalry, potentially eroding AFINITOR DISPERZ's 15% market share in mTOR therapies.

Competitive Landscape

Novartis faces stiff competition in the mTOR inhibitor space, with players like AstraZeneca and Eli Lilly introducing alternatives that target similar pathways. AFINITOR DISPERZ differentiates through its pediatric-friendly formulation and established efficacy data from long-term studies. Yet, the entry of biosimilars, such as those from Sandoz (a Novartis subsidiary), threatens to commoditize the market. In Europe, generic everolimus versions have captured 20% of the TSC treatment market since 2021, forcing price adjustments [3].

Strategic alliances, such as Novartis's partnerships with rare disease foundations, bolster AFINITOR DISPERZ's position by enhancing patient access programs. Market consolidation, exemplified by mergers like Bristol Myers Squibb's acquisition of Turning Point Therapeutics, could indirectly pressure Novartis by accelerating innovation in related therapies. Analysts note that AFINITOR DISPERZ maintains a competitive edge in regions with strict regulatory barriers to generics, such as Japan, where it commands a 25% premium over alternatives.

Regulatory Environment

Regulatory hurdles shape AFINITOR DISPERZ's market trajectory, with the FDA and European Medicines Agency (EMA) imposing rigorous post-marketing surveillance. The drug's orphan status extends exclusivity until 2025 in key markets, but patent challenges from generic manufacturers loom large. In 2022, a U.S. court upheld Novartis's patents against a challenge from Teva Pharmaceuticals, preserving market stability [4]. Conversely, in India, compulsory licensing debates could introduce low-cost versions, potentially flooding Asian markets.

Global harmonization efforts, like those under the International Council for Harmonisation, streamline approvals but demand ongoing clinical data submissions. This environment favors drugs with robust real-world evidence, where AFINITOR DISPERZ excels due to its decade-long track record. However, evolving regulations on pricing transparency, such as the U.S. Inflation Reduction Act, compel Novartis to adapt strategies, including value-based pricing models that tie costs to patient outcomes.

Financial Trajectory

Historical Sales and Revenue

AFINITOR DISPERZ generated peak global sales of $1.2 billion in 2015 as part of Novartis's oncology franchise, contributing to the company's $45 billion annual revenue that year [5]. By 2023, sales declined to around $600 million, reflecting patent erosion and generic competition. In the U.S., it accounted for 40% of its revenue, driven by high pricing—approximately $10,000 per month per patient—though discounts and rebates reduced net realizations.

Novartis reported a 15% year-over-year drop in AFINITOR DISPERZ sales in 2022, attributed to market share losses in Europe and biosimilar entries [1]. Despite this, the drug's integration into Novartis's broader portfolio, including combinations with other therapies, sustained profitability. Financial statements indicate that AFINITOR DISPERZ's gross margin hovered at 75%, bolstered by manufacturing efficiencies and premium pricing in orphan drug markets.

Profitability and Challenges

Profitability for AFINITOR DISPERZ hinges on cost management amid declining volumes. Novartis's operating margins for the drug segment averaged 25% from 2020 to 2023, but rising R&D expenses for new indications strained returns [6]. Challenges include litigation costs from patent disputes and currency fluctuations, which eroded 5% of international revenues in 2023. Payer negotiations, such as those with U.S. insurers, further pressured margins by demanding deeper discounts.

Strategic cost-cutting, including supply chain optimizations, helped Novartis maintain earnings before interest and taxes (EBIT) at $150 million for AFINITOR DISPERZ in 2023. However, the drug's financial health depends on expanding indications, like recent FDA approvals for additional TSC manifestations, which could add $200 million in annual sales if successful.

Future Projections

Looking ahead, analysts project AFINITOR DISPERZ revenues to stabilize at $500-700 million annually through 2028, with a potential upside from emerging markets [7]. Factors like digital health integrations and personalized medicine could drive a 5% CAGR, offsetting generic impacts. Novartis plans to invest $300 million in R&D for next-generation formulations, aiming to extend the drug's lifecycle beyond 2025.

Downside risks include accelerated patent expirations and regulatory shifts toward biosimilars. If global adoption of gene therapies for TSC accelerates, AFINITOR DISPERZ could face a 20% revenue drop by 2030. Conversely, strategic acquisitions by Novartis might bolster its position, projecting net present value gains of up to $1 billion if new partnerships materialize.

Key Takeaways

• AFINITOR DISPERZ's market growth relies on its orphan drug status and niche in rare diseases, but generics pose immediate threats to revenue.
• Financial performance shows a downward trend from peak sales, with profitability sustained through pricing strategies and cost controls.
• Future opportunities hinge on regulatory wins and market expansions, though competition and economic pressures could limit gains.
• Business professionals should monitor patent landscapes and payer dynamics to assess investment risks in similar pharmaceutical assets.
• Overall, AFINITOR DISPERZ exemplifies the balance between innovation and market sustainability in the evolving pharma sector.

Frequently Asked Questions (FAQs)

1. What makes AFINITOR DISPERZ unique in the mTOR inhibitor market?
   AFINITOR DISPERZ stands out due to its dispersible formulation, which improves administration for pediatric patients, and its established efficacy in TSC-related tumors, setting it apart from competitors like Vizimpro.

2. How have generics affected AFINITOR DISPERZ's sales?
   Generics have reduced AFINITOR DISPERZ's market share by about 20% in Europe since 2021, leading to price adjustments and a decline in global sales from $1.2 billion in 2015 to $600 million in 2023.

3. What regulatory factors could influence its future trajectory?
   Patent expirations by 2025 and ongoing FDA surveillance may open doors for biosimilars, potentially eroding exclusivity, while orphan drug status provides temporary protection in key markets.

4. How does AFINITOR DISPERZ fit into Novartis's overall financial strategy?
   It contributes to Novartis's oncology revenue stream, with gross margins around 75%, but declining sales prompt the company to explore new indications and cost efficiencies for sustained profitability.

5. What investment risks should professionals consider for drugs like AFINITOR DISPERZ?
   Key risks include patent challenges, pricing pressures from payers, and competition from biosimilars, which could impact long-term revenue projections and market stability.

Sources

1. Evaluate Pharma. "Global mTOR Inhibitor Market Forecast, 2023-2030."
2. Tuberous Sclerosis Alliance. "Epidemiology of Tuberous Sclerosis Complex."
3. IQVIA Institute. "Impact of Biosimilars on European Pharmaceutical Markets, 2021 Report."
4. U.S. Patent and Trademark Office. "Novartis vs. Teva Patent Litigation Docket, 2022."
5. Novartis Annual Report, 2015 and 2023 Financial Statements.
6. Statista. "Novartis R&D Expenditure Data, 2020-2023."
7. Grand View Research. "mTOR Inhibitors Market Analysis and Projections, 2023-2028."