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MAYZENT Drug Patent Profile

Which patents cover Mayzent, and what generic alternatives are available?

Mayzent is a drug marketed by Novartis and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-three patent family members in forty-four countries.

The generic ingredient in MAYZENT is siponimod. One supplier is listed for this compound. Additional details are available on the siponimod profile page.

DrugPatentWatch^® Generic Entry Outlook for Mayzent

Mayzent was eligible for patent challenges on March 26, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 27, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for MAYZENT

International Patents:	193
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	3
Patent Applications:	271
Drug Prices:	Drug price information for MAYZENT
What excipients (inactive ingredients) are in MAYZENT?	MAYZENT excipients list
DailyMed Link:	MAYZENT at DailyMed

See drug prices for MAYZENT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MAYZENT

NDA:

209884

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MAYZENT

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

Sponsor	Phase
Robert Zivadinov, MD, PhD	Phase 4
Novartis Pharmaceuticals	Phase 4
Novartis Pharmaceuticals	Phase 3

See all MAYZENT clinical trials

Pharmacology for MAYZENT

Drug Class	Sphingosine 1-phosphate Receptor Modulator
Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

Paragraph IV (Patent) Challenges for MAYZENT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MAYZENT	Tablets	siponimod	0.25 mg, 1 mg and 2 mg	209884	5	2023-03-27

US Patents and Regulatory Information for MAYZENT

MAYZENT is protected by four US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-001	Mar 26, 2019		RX	Yes	No
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-002	Mar 26, 2019		RX	Yes	Yes
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-003	Aug 24, 2021		RX	Yes	No

International Patents for MAYZENT

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

Country	Patent Number	Title	Estimated Expiration
South Korea	101660555
Spain	2467160
Taiwan	I355931

Supplementary Protection Certificates for MAYZENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379069	2020017	Norway		PRODUCT NAME: SIPONIMOD; REG. NO/DATE: EU/1/19/1414 20200127
2379069	C20200016 00335	Estonia		PRODUCT NAME: SIPONIMOOD;REG NO/DATE: EU/1/19/1414 15.01.2020
2379069	LUC00160	Luxembourg		PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115

MAYZENT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mayzent

Introduction to Mayzent

Mayzent, developed by Novartis, is a significant addition to the treatment landscape for multiple sclerosis (MS), particularly for patients with relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). Here, we delve into the market dynamics and financial trajectory of this drug.

FDA Approval and Clinical Significance

Mayzent (siponimod) was approved by the FDA in March 2019, marking the first new drug in over 15 years for the treatment of secondary progressive MS. The approval was based on the Phase 3 EXPAND trial, which demonstrated that Mayzent reduced the risk of disability progression at three months by 21% compared to placebo and decreased the annualized relapse rate by 55%[1][2].

Market Positioning

Mayzent enters a highly competitive market dominated by other MS treatments such as Ocrevus from Roche and Tecfidera from Biogen. Despite this, Mayzent has carved out a niche by being the only disease-modifying therapy to demonstrate efficacy in a typical secondary progressive MS patient population. However, analysts have noted that Mayzent has limited differentiation and only modest clinical data compared to its competitors[1].

Pricing Strategy

Novartis priced Mayzent at $88,500 per year, which is in line with other MS medications. For context, Gilenya, another Novartis MS drug, costs $98,500 per year, and Biogen's Tecfidera is priced at $93,700 per year. This pricing strategy aims to ensure affordable access for patients while maintaining competitiveness in the market[1].

Financial Projections and Performance

Mayzent is one of the 10 medicines Novartis has identified for potential future sales above $1 billion annually. The commercial success of Mayzent is crucial for Novartis, especially as it faces the loss of patent protection for Gilenya in the near future. The drug's performance is expected to cushion the revenue impact from this patent expiration[1].

Market Growth and Trends

The global multiple sclerosis drugs market is projected to grow significantly, from $21.16 billion in 2024 to $38.94 billion by 2032, at a CAGR of 7.9%. This growth is driven by new product launches, increasing government initiatives, rising prevalence of MS, and significant R&D investments. North America, where Mayzent is approved, dominates this market with a 48.2% market share in 2023[4].

Competitive Landscape

Mayzent operates in a competitive landscape where Biogen and F. Hoffmann-La Roche Ltd. are major players. Biogen dominated the market in 2023, and other significant players like Novartis, Sanofi, and Merck KGaA are also expanding their MS drug portfolios. The market is seeing a shift towards monoclonal antibodies, with Ocrevus being a notable example, generating $5.56 billion in revenue in 2021[4].

Regional Expansion and Government Initiatives

The Asia Pacific region is expected to register the highest CAGR during the forecast period due to improved distribution networks and collaborations between pharmaceutical companies. Government initiatives to reduce treatment costs and improve healthcare spending are also boosting demand for MS drugs globally[4].

Clinical Benefits and Patient Impact

Mayzent has shown significant clinical benefits, particularly in delaying disability progression and reducing the risk of becoming wheelchair-dependent. Data from the EXPAND trial indicated that Mayzent can delay the time to wheelchair dependence by approximately 4.3 years compared to placebo. These benefits are crucial for patients, as they translate into improved quality of life and slower disease progression[2].

Safety and Side Effects

While Mayzent offers substantial benefits, it also comes with potential side effects. These include an increased risk of macular edema, dose-dependent reductions in lung function, and other respiratory effects. Monitoring and careful management of these side effects are essential for patient safety[5].

Adoption and Acceptance

The adoption of Mayzent has been gradual, with Dr. Ludwig Kappos noting that it is "really coming slowly into that" due to the lack of alternatives for regular use. As more data becomes available and clinicians become more familiar with the drug, its acceptance is expected to increase[2].

Key Takeaways

• FDA Approval: Mayzent was approved for the treatment of RRMS and active SPMS, marking a significant milestone in MS treatment.
• Clinical Benefits: It reduces the risk of disability progression and annualized relapse rates, and delays the time to wheelchair dependence.
• Pricing: Priced competitively at $88,500 per year.
• Market Growth: Part of a growing MS drugs market projected to reach $38.94 billion by 2032.
• Competitive Landscape: Operates in a competitive market with major players like Biogen and Roche.
• Regional Expansion: Expected to benefit from government initiatives and improved distribution networks globally.

FAQs

Q: What is Mayzent used for? A: Mayzent (siponimod) is used for the treatment of relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (SPMS).

Q: How does Mayzent compare to other MS treatments? A: Mayzent is the only disease-modifying therapy that has demonstrated efficacy in a typical secondary progressive MS patient population, but it has limited differentiation and modest clinical data compared to competitors like Ocrevus.

Q: What are the potential side effects of Mayzent? A: Mayzent can cause macular edema, dose-dependent reductions in lung function, and other respiratory effects.

Q: How is Mayzent priced? A: Mayzent is priced at $88,500 per year, which is in line with other MS medications.

Q: What is the projected market growth for MS drugs? A: The global MS drugs market is projected to grow from $21.16 billion in 2024 to $38.94 billion by 2032, at a CAGR of 7.9%.

Sources

1. Biopharma Dive: "Novartis wins key US approval for multiple sclerosis drug Mayzent"
2. Multiple Sclerosis News Today: "#ECTRIMS2019 - Mayzent's Benefits for MS Patients a 'Key Question,' Says EXPAND’s Principal Investigator"
3. Novartis: "q2-2024-investor-presentation.pdf"
4. Fortune Business Insights: "Multiple Sclerosis Drugs Market | Competitive Landscape [2032]"
5. Novartis: "MAYZENT® (siponimod) tablets, for oral use"