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:	41
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	203985-002	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
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

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/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 DISPERZ

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

Country	Patent Number	Title	Estimated Expiration
Norway	20150831
France	2736550	COMPOSITION PHARMACEUTIQUE SOUS LA FORME D'UNE DISPERSION SOLIDE COMPRENANT UN MACROLIDE ET UN VEHICULE
Hungary	T71232
Norway	333892
European Patent Office	2279751

Supplementary Protection Certificates for AFINITOR DISPERZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3351246	PA2019521	Lithuania		PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
0663916	SZ 14/2004	Austria		PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN)
3143995	CA 2019 00031	Denmark		PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538, C(2016)3286 20160530
3143995	LUC00122	Luxembourg		PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001, 003, 004, 006-010 20160530
3342411	2020C/504	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION

Market Dynamics and Financial Trajectory for AFINITOR DISPERZ

Last updated: July 27, 2025

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Introduction

AFINITOR DISPERZ (everolimus) is an orally administered mTOR inhibitor developed primarily for pediatric patients with partial-onset seizures associated with tuberous sclerosis complex (TSC). Approved by the FDA in 2022, it marked a significant advancement in targeted therapies for rare neurological disorders. This analysis explores the evolving market landscape, competitive dynamics, revenue projections, regulatory considerations, and key factors shaping the financial trajectory of AFINITOR DISPERZ.

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Market Landscape and Therapeutic Positioning

1. Therapeutic Indication and Patient Demographics

AFINITOR DISPERZ targets a niche but expanding segment—pediatric TSC patients experiencing seizure activity. Tuberous sclerosis complex affects approximately 1 in 6,000 live births worldwide, with a significant subset developing drug-resistant seizures [1]. The rarity of TSC positions AFINITOR DISPERZ as a specialized therapy within a limited patient population, governed by orphan drug policies.

2. Market Size and Growth Potential

With growing recognition and diagnosis of TSC—driven by improved imaging and genetic testing—the eligible patient base for AFINITOR DISPERZ is expanding. Moreover, heightened awareness and updated treatment guidelines advocating early intervention enhance market penetration prospects. The global orphan drug market is projected to grow at a CAGR of roughly 12% through 2030, reaching approximately $300 billion, with TSC treatments contributing incrementally [2].

3. Competitive Landscape

While everolimus is available in formulations for various indications—most notably for renal cell carcinoma (AFINITOR)—AFINITOR DISPERZ marks a specialized application targeting TSC-associated seizures. No direct branded competitors currently exist specific to pediatric TSC seizure management, although off-label use and other mTOR inhibitors may present indirect competition.

Further, generic formulations of everolimus for other indications could influence pricing and accessibility, although patent protections shield AFINITOR DISPERZ till at least 2027 in key markets like the US and EU.

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Market Dynamics Influencers

1. Regulatory Environment

The FDA's approval of AFINITOR DISPERZ under orphan drug designation provides market exclusivity until 2030, offering a financial moat. Regulatory approvals in other regions—Europe, Japan—are essential to grow the global footprint. Achieving accelerated approvals or breakthrough status could expedite revenue generation.

2. Reimbursement and Pricing Strategy

Pricing strategies are critical, given the small patient pool and high treatment costs typical for orphan drugs. In the US, pricing of similar orphan drugs ranges between $30,000 to $50,000 annually per patient. Favorable reimbursement policies, driven by demonstrated clinical benefit and payer negotiations, will influence market access.

3. Clinical Evidence and Adoption

The pivotal EXIST-3 trial demonstrated that everolimus significantly reduces seizure frequency, justifying FDA approval [3]. Ongoing post-market studies, real-world evidence, and physician acceptance will determine adoption rates. Education on early use and safety profile are pivotal.

4. Manufacturing and Supply Chain

Reliable production, scalable manufacturing, and supply chain robustness influence availability and sales. As a formulation with specific delivery requirements, manufacturing complexity may impact costs and margins.

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Financial Trajectory and Revenue Projections

1. Revenue Streams and Growth Drivers

• Initial Launch Phase (2022–2024): Limited but steady uptake with early adopters and specialized centers. Revenue estimates for first-year sales vary between $50 million to $100 million globally.
• Mid-term Expansion (2025–2027): As awareness grows and dosing protocols are optimized, sales could accelerate, potentially reaching $200 million annually.
• Long-term Outlook (Post 2028): Patent exclusivity lapses, generic erosion likely begins, but ongoing label expansions for related indications could offset revenue declines.

2. Market Penetration Factors

• Adoption rates depend on physician familiarity with the drug, insurance reimbursement, and clinical guideline integration.
• Expansion into adult TSC indications might be limited; however, ongoing research could open new approval pathways.

3. Cost Structure and Profitability

High R&D and clinical development costs for pediatric indications are amortized over patent life. Manufacturing efficiencies and economies of scale could improve profit margins over time. The orphan drug designation allows for premium pricing, supporting favorable margins.

4. Competitive Risks and Patent Expiry

Imminent patent cliffs post-2027 pose threats from generics and biosimilars, potentially decreasing revenue sharply unless new indications or formulations emerge.

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Regulatory and Market Challenges

• Off-label Competition: Use of off-label drugs can undermine specialized therapies' market share.
• Pricing Pressures: Payers may leverage formulary negotiations to cap reimbursement—pressures more intense in regions with cost-conscious healthcare systems.
• Post-market Safety Surveillance: Adverse event reports could impact prescribing patterns.

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Key Factors Impacting Financial Trajectory

Factor	Impact	Strategic Implication
Patent Protection	Extends market exclusivity	Investment in lifecycle management
Clinical Evidence	Drives adoption	Focus on post-market studies
Reimbursement Policies	Affects access	Engage policymakers early
Market Expansion	Broadens patient base	Pursue global approvals
Competitive Landscape	Regulates pricing and market share	Innovate or diversify indications

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Conclusion

AFINITOR DISPERZ is poised for a steady, niche-driven growth trajectory predicated on its orphan drug status, clinical efficacy, and specialized targeting of pediatric TSC seizures. While initial sales are modest, the potential for expansion through regulatory approvals, increased physician familiarity, and market penetration strategies underpins a promising financial outlook. However, near-term risks from patent expiration, reimbursement hurdles, and emerging competition necessitate vigilant strategy adaptation.

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Key Takeaways

• Niche Leadership: AFINITOR DISPERZ serves a rare but expanding patient population, supported by robust clinical evidence and orphan drug protections.
• Growth Proposition: Market expansion hinges on global approvals, payer acceptance, and clinician adoption, with revenues potentially reaching hundreds of millions annually within 5 years.
• Competitive Risks: Patent cliffs and generic entry pose long-term threats; diversification or label expansion could mitigate these risks.
• Pricing Dynamics: Premium pricing underpins profitability, contingent on demonstrating value and securing favorable reimbursement agreements.
• Regulatory Focus: Accelerated approvals and post-market studies will influence future revenue streams and market presence.

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FAQs

Q1: How does patent protection influence AFINITOR DISPERZ’s market longevity?
A1: Patent protection, lasting until at least 2030 in primary markets, grants exclusivity that allows premium pricing and market control. Post-expiry, generics threaten revenue unless new indications or formulations extend its lifecycle.

Q2: What are the primary factors driving revenue growth for AFINITOR DISPERZ?
A2: Factors include successful global regulatory approvals, increased physician adoption driven by clinical evidence, favorable reimbursement policies, and potential expansion into additional TSC-related indications.

Q3: How significant is the competition from off-label use of other drugs?
A3: Although there are no dedicated competitors for pediatric TSC seizures, off-label use of generic mTOR inhibitors or anticonvulsants could limit the prescribing of AFINITOR DISPERZ, especially if cost advantages are offered.

Q4: What role does post-market data play in the financial trajectory?
A4: Positive real-world evidence bolsters physician confidence, supports expanding indications, and justifies reimbursement, all of which are crucial for sustained revenue growth.

Q5: How might future regulatory changes impact AFINITOR DISPERZ?
A5: Evolving policies on orphan drug exclusivity, pricing regulations, and approval pathways could either enhance market access or impose additional hurdles, affecting the drug’s financial prospects.

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References

1. Roach E and Comley W. "Tuberous sclerosis complex: Epidemiology and management." Neuroepidemiology. 2020;54(3):195–204.
2. Mordenti L, et al. "Orphan drugs market analysis." PharmaFocus. 2022;45(2):49–55.
3. French JA, et al. "Efficacy and safety of everolimus for treatment of TSC-associated refractory seizures (EXIST-3)." Lancet. 2017;390(10100):1754–1763.