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. Eleven 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
Patent Applications:	4,495
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	8,778,962*PED
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012	8,617,598*PED
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012	8,778,962*PED

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
Lithuania	PA2016035
Turkey	200201428
Russian Federation	2445093	ИНГИБИРОВАНИЕ ИЛИ ПРОФИЛАКТИКА НАРУШЕННОЙ РЕГУЛЯЦИИ АНГИОГЕНЕЗА С ПОМОЩЬЮ ПРОИЗВОДНЫХ РАПАМИЦИНА И ФАРМАЦЕВТИЧЕСКИЕ КОМБИНАЦИИ, СОДЕРЖАЩИЕ ПРОИЗВОДНОЕ РАПАМИЦИНА (INHIBITION OR PREVENTION OF DISTURBED ANGIOGENIC REGULATION WITH USING RAPAMYCIN DERIVATIVES, AND PHARMACEUTICAL COMPOSITIONS CONTAINING RAPAMYCIN DERIVATIVE)

Supplementary Protection Certificates for AFINITOR DISPERZ

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	300769	Netherlands		PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/001, 003, 004 EN 006-010 (C(2012)5347) 20120725
0663916	SZ 14/2004	Austria		PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN)

AFINITOR DISPERZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Afinitor Disperz

Overview of Afinitor Disperz

Afinitor Disperz, developed by Novartis, is a formulation of everolimus, an mTOR (mechanistic target of rapamycin) inhibitor. It is designed for the treatment of various conditions, including subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) and TSC-associated partial-onset seizures.

Market Size and Growth

The global brain tumor drugs market, which includes Afinitor Disperz, is projected to grow significantly. By 2027, this market is expected to reach $4.74 billion, growing at a compound annual growth rate (CAGR) of 6.1% from 2023[1].

Key Market Drivers

Increasing Prevalence of TSC and Associated Conditions

The growing prevalence of tuberous sclerosis complex and its associated conditions, such as SEGA and partial-onset seizures, drives the demand for effective treatments like Afinitor Disperz.

FDA Approvals and Regulatory Support

The FDA approval of Afinitor Disperz for the treatment of TSC-associated partial-onset seizures in adult and pediatric patients aged 2 years and older has been a significant market driver. This approval was based on the efficacy and safety data from the Phase III EXIST-3 study[4].

Clinical Efficacy

The EXIST-3 study demonstrated that Afinitor Disperz significantly reduces the frequency of seizures in patients with TSC. The median percentage reduction from baseline in seizure frequency was 29.3% for the low-exposure group and 39.6% for the high-exposure group, compared to 14.9% for the placebo group[4].

Financial Performance

Revenue Projections

Afinitor Disperz is a key contributor to the revenue of Novartis. The drug's sales are included in the broader category of brain tumor drugs, which saw a market value of $3.49 billion in 2022 and is expected to grow to $3.74 billion in 2023[1].

Cost Analysis

The cost of Afinitor Disperz treatment is significant. For patients with a body surface area (BSA) of 0.5 to 1.2 m², the annual drug cost is approximately $69,927. For patients with a BSA greater than 2.1 m², the annual cost can be as high as $104,890[5].

Long-Term Costs

Over longer time horizons, the costs associated with Afinitor Disperz treatment can be substantial. For example, the 10-year cost for patients with a BSA less than 2.2 m² is estimated at $699,267, and for those with a BSA greater than 2.2 m², it is estimated at $1,048,900[5].

Competitive Landscape

Key Players

The market for brain tumor drugs, including Afinitor Disperz, is highly competitive with several major pharmaceutical companies involved. Key players include Novartis AG, Pfizer Inc., Merck & Co. Inc., AstraZeneca, and Roche, among others[1].

Market Share

Novartis, the manufacturer of Afinitor Disperz, holds a significant market share in the brain tumor drugs market. The company's strong research and development capabilities and its portfolio of approved drugs contribute to its market position.

Regulatory and Clinical Environment

FDA Approvals

The FDA approval of Afinitor Disperz for TSC-associated partial-onset seizures has been crucial for its market success. This approval underscores the drug's efficacy and safety profile, enhancing its credibility and adoption[4].

Clinical Trials

The EXIST-3 study, a Phase III clinical trial, provided robust data supporting the approval of Afinitor Disperz. Such clinical trials are essential for demonstrating the drug's effectiveness and safety, which in turn influences regulatory decisions and market acceptance.

Patient and Healthcare Provider Perspectives

Patient Outcomes

Afinitor Disperz has shown significant improvements in patient outcomes, particularly in reducing the frequency and severity of seizures in patients with TSC. This improvement in quality of life is a key factor driving patient and healthcare provider preference for the drug[4].

Adverse Events

While Afinitor Disperz is effective, it is associated with certain adverse events such as stomatitis, diarrhea, nasopharyngitis, upper respiratory tract infection, and pyrexia. These side effects need to be managed carefully to ensure optimal patient outcomes[4].

Economic Impact

Cost-Effectiveness

The cost-effectiveness of Afinitor Disperz is a subject of ongoing analysis. While the drug is expensive, it can prevent or delay the need for more invasive and costly procedures such as resective surgery or shunt placement, potentially reducing overall healthcare costs[5].

Pharmacoeconomic Analysis

Pharmacoeconomic studies have compared the costs associated with Afinitor Disperz treatment against other treatment options. These studies help in understanding the economic benefits and trade-offs of using Afinitor Disperz in clinical practice[5].

Future Outlook

Market Expansion

The market for Afinitor Disperz is expected to expand as the drug gains approval for additional indications and as awareness and adoption increase globally.

Research and Development

Novartis continues to invest in research and development, which could lead to new formulations or indications for Afinitor Disperz, further enhancing its market potential.

Key Takeaways

• Market Growth: The brain tumor drugs market, including Afinitor Disperz, is projected to grow to $4.74 billion by 2027.
• Clinical Efficacy: Afinitor Disperz has demonstrated significant efficacy in reducing seizure frequency in patients with TSC.
• Financial Performance: The drug contributes substantially to Novartis' revenue, with high annual treatment costs.
• Regulatory Support: FDA approvals have been crucial for the drug's market success.
• Competitive Landscape: The market is highly competitive, with Novartis holding a significant market share.
• Economic Impact: The drug can be cost-effective by preventing more invasive and costly procedures.

FAQs

Q: What is Afinitor Disperz used for?

A: Afinitor Disperz is used for the treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) and TSC-associated partial-onset seizures.

Q: What is the expected market size for brain tumor drugs by 2027?

A: The global brain tumor drugs market is expected to grow to $4.74 billion by 2027[1].

Q: What are the common adverse events associated with Afinitor Disperz?

A: Common adverse events include stomatitis, diarrhea, nasopharyngitis, upper respiratory tract infection, and pyrexia[4].

Q: How does Afinitor Disperz compare to other treatment options in terms of cost?

A: Afinitor Disperz is expensive, but it can prevent or delay the need for more invasive and costly procedures, potentially reducing overall healthcare costs[5].

Q: What is the significance of the EXIST-3 study for Afinitor Disperz?

A: The EXIST-3 study provided robust data supporting the FDA approval of Afinitor Disperz for TSC-associated partial-onset seizures, demonstrating its efficacy and safety[4].

Sources

1. Brain Tumor Drugs Global Market Report 2023: A $4.74 Billion Market by 2027 - Focus on Afinitor (Everolimus), Afinitor Disperz (Everolimus), Belzutifan, and Bevacizumab[1].
2. Novartis Annual Report 2018: Financial performance measures related to Group, division or business segment[2].
3. Afinitor Drug Market Report 2024 (Global Edition): Market size, revenue, forecast, and CAGR[3].
4. Novartis drug Afinitor DISPERZ receives FDA approval: For the treatment of TSC-associated partial-onset seizures[4].
5. CDR Pharmacoeconomic Review Report for Afinitor: Cost analysis comparing one-year costs associated with everolimus treatment[5].