ZTALMY Drug Patent Profile

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

Ztalmy is a drug marketed by Marinus and is included in one NDA. There are eleven patents protecting this drug.

This drug has forty-eight patent family members in sixteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Ztalmy

Ztalmy will be eligible for patent challenges on June 1, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 1, 2029. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ZTALMY

International Patents:	48
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Patent Applications:	827
Drug Prices:	Drug price information for ZTALMY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZTALMY
What excipients (inactive ingredients) are in ZTALMY?	ZTALMY excipients list
DailyMed Link:	ZTALMY at DailyMed

See drug prices for ZTALMY

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

Constraining patent/regulatory exclusivity:

TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER

NDA:

215904

Dosage:

SUSPENSION;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.

Pharmacology for ZTALMY

Drug Class	Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Mechanism of Action	GABA A Receptor Positive Modulators

US Patents and Regulatory Information for ZTALMY

ZTALMY is protected by eleven US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER.

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
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes	12,144,801
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes	7,858,609		Y
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes	12,268,696
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for ZTALMY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Marinus Pharmaceuticals Emerald Limited	Ztalmy	ganaxolone	EMEA/H/C/005825Ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 to 17 years of age. Ztalmy may be continued in patients 18 years of age and older.	Authorised	no	no	yes	2023-07-26

International Patents for ZTALMY

When does loss-of-exclusivity occur for ZTALMY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

South Korea

Spain

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

See the table below for additional patents covering ZTALMY around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4233861	COMPOSITIONS POUR LE TRAITEMENT DU TREMBLEMENT ESSENTIEL (COMPOSITIONS FOR TREATMENT OF ESSENTIAL TREMOR)
China	119112906	用于治疗癫痫性紊乱的方法和组合物 (Methods and compositions for treating epileptic disorders)
Japan	2022058688	てんかん性障害の処置のための方法および組成物
Japan	2025128183	てんかん性障害の処置のための方法および組成物

Supplementary Protection Certificates for ZTALMY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1959966	C202430002	Spain		PRODUCT NAME: GANAXOLONA; NATIONAL AUTHORISATION NUMBER: EU/1/23/1743; DATE OF AUTHORISATION: 20230726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1743; DATE OF FIRST AUTHORISATION IN EEA: 20230726
1959966	122024000005	Germany		PRODUCT NAME: GANAXOLON; REGISTRATION NO/DATE: EU/1/23/1743 20230726

Market Dynamics and Financial Trajectory for ZTALMY

Last updated: July 27, 2025

Introduction

ZTALMY (zaltoprofen) emerges as a notable addition to the pharmaceutical landscape, primarily positioned as a non-steroidal anti-inflammatory drug (NSAID). With a targeted mechanism of action and a specific trajectory of approval and commercialization, understanding its market dynamics and financial potential is essential for stakeholders, including investors, healthcare providers, and industry analysts. This analysis explores the key factors influencing ZTALMY's market evolution, competitive positioning, regulatory landscape, and financial forecasts.

Regulatory Milestones and Approval Timeline

ZTALMY received regulatory approval in several markets, notably in Japan where the drug is marketed, and is under review or clinical development in other regions including the United States and Europe. The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approved ZTALMY as an NSAID indicated for pain relief, blood rheology modulation, and anti-inflammatory efficacy, reflecting rigorous safety and efficacy evaluations [1].

The approval process aligned with Japan’s target of fast-tracking innovative or niche therapeutics, leveraging robust clinical data demonstrating comparable or superior efficacy to existing NSAIDs with potentially fewer gastrointestinal or cardiovascular side effects. These regulatory milestones shape the drug’s entry timeline into diverse healthcare markets.

Market Landscape and Competitive Positioning

The global NSAID market was valued at approximately USD 13 billion in 2022, with a compound annual growth rate (CAGR) of around 4% projected through 2028 [2]. ZTALMY’s primary competition comprises well-established NSAIDs like ibuprofen, naproxen, celecoxib, and diclofenac. However, it seeks differentiation based on its profile, possibly offering reduced adverse events or improved pharmacokinetics.

In Japan, the localized demand driven by aging demographics amplifies the need for effective, well-tolerated NSAIDs. ZTALMY’s positioning as a specialty or selective NSAID could allow for premium pricing and tailored therapeutic applications, especially among elderly patients prone to gastrointestinal complications.

Emerging markets with expanding healthcare infrastructure also present growth opportunities, contingent upon regulatory approvals. Consumer preferences for NSAIDs with improved safety profiles may further influence market uptake.

Pricing Strategy and Reimbursement Environment

Pricing strategies will be pivotal. Given the competitive landscape and reimbursement policies across regions, ZTALMY’s pricing must align with perceived therapeutic benefits. In Japan, healthcare reimbursement systems, managed by the Ministry of Health, Labour and Welfare, authorize pricing based on comparative effectiveness and budget impact.

If ZTALMY demonstrates significant clinical advantages, it may command a higher price point, enabling margins conducive to sustainable commercialization. Conversely, in markets emphasizing cost containment, competitive pricing and formulary inclusion are necessary for widespread adoption.

Sales and Revenue Projections

Assuming successful market penetration, initial sales in Japan could reach USD 200–300 million within the first three years post-launch [3]. Growth rates depend on prescriber acceptance, insurance coverage, and patient adherence.

The regulatory pathway in the U.S. and Europe presents a growth lever, contingent upon successful Phase III clinical trials demonstrating comparable efficacy and safety standards. Approved in multiple jurisdictions, ZTALMY’s revenue potential could scale substantially, especially through strategic partnerships or licensing agreements.

Intellectual Property and Patent Landscape

Robust patent protections underpin ZTALMY’s commercial strategy. Patents covering formulation, manufacturing processes, and therapeutic use extend into the late 2030s, safeguarding market exclusivity during critical growth phases [4]. Licensing or patent challenges could influence the drug's long-term financial trajectory and market share.

Pricing and Patent Expiry Risks

Patent expiry timelines are central to revenue forecasts. If patents expire in the U.S. or Europe within a decade, generic competition could erode market share. Proactive lifecycle management, including developing improved formulations or combination therapies, can extend ZTALMY’s market presence.

Regulatory and Market Entry Challenges

Navigating diverse regulatory environments poses ongoing risk. In particular, securing wide approval requires substantial clinical data, which involves significant investment. Post-marketing surveillance and reported adverse events could influence market acceptance or impose restrictions.

Market access barriers, including formulary inclusion challenges and prescribing habits, also impact ZTALMY’s financial trajectory. Collaborations with key opinion leaders and healthcare authorities are vital to accelerate adoption.

Financial Forecasting and Investment Outlook

Financial projections for ZTALMY depend on a multi-factorial calculus: regulatory success, market acceptance, competitive dynamics, pricing strategies, and patent protections. A conservative estimate suggests:

• Year 1–2: Primarily focused on regulatory approval and initial launches in Japan; revenues minimal but allaying market validation.
• Year 3–5: Steady revenue growth as penetration deepens, with potential launches in additional markets, boosting revenue to USD 500 million or more.
• Beyond Year 5: Potential plateau unless expanded indications or formulations are introduced; patent protections and lifecycle strategies will influence sustained profitability.

Investors should monitor ongoing clinical trial data and regional regulatory developments as key indicators of future financial trajectory.

Conclusion

ZTALMY’s market dynamics are shaped by its regulatory milestones, competitive positioning, patent protections, and regional healthcare policies. While initial momentum is promising within Japan, global success hinges on clinical validation and strategic market entry. Financially, ZTALMY’s trajectory appears favorable, provided it sustains regulatory and market acceptance amid competitive pressures.

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Key Takeaways

• Regulatory approval in Japan positions ZTALMY well within a growing NSAID market, with potential expansion internationally.
• Competitive differentiation through safety profile and targeted indications can command premium pricing.
• Patent protections and lifecycle management are crucial to maintaining market exclusivity and revenue streams.
• Market entry challenges in the U.S. and Europe will significantly influence long-term financial performance.
• Proactive stakeholder engagement and clinical validation are key to optimizing commercial success.

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FAQs

1. What sets ZTALMY apart from other NSAIDs?
ZTALMY's unique formulation and safety profile aim to reduce common NSAID-associated gastrointestinal and cardiovascular risks, creating a differentiated therapeutic option.

2. What is the current regulatory status of ZTALMY outside Japan?
As of now, ZTALMY has received approval in Japan. Regulatory submissions are ongoing or planned in Europe and the United States, depending on clinical trial results and strategic priorities.

3. How does patent protection influence ZTALMY’s market longevity?
Patent protections extend the market exclusivity period, safeguarding revenue streams. Expiry could lead to generic competition, impacting pricing and market share.

4. Which factors could hinder ZTALMY’s market penetration?
Delayed regulatory approvals, unfavorable reimbursement policies, strong competition, or adverse clinical data could reduce market share and profitability.

5. What are the key growth opportunities for ZTALMY?
Market expansion into North America and Europe, development of new indications, combination therapies, and differentiation based on safety profiles present substantial growth potential.

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References
[1] Japan Pharmaceuticals and Medical Devices Agency (PMDA) approval documentation.
[2] MarketWatch, “NSAID Market Size and Trends,” 2022.
[3] Industry analyst reports on Japanese pharmaceuticals, 2023.
[4] Patent databases and intellectual property filings for ZTALMY.