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XELSTRYM Drug Patent Profile

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

Xelstrym is a drug marketed by Noven Pharms Inc and is included in one NDA. There are six patents protecting this drug.

This drug has thirty-three patent family members in twelve countries.

The generic ingredient in XELSTRYM is dextroamphetamine. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dextroamphetamine profile page.

DrugPatentWatch^® Generic Entry Outlook for Xelstrym

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 22, 2025. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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.

There is one tentative approval for the generic drug (dextroamphetamine), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XELSTRYM

International Patents:	33
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Patent Applications:	4,245
Drug Prices:	Drug price information for XELSTRYM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XELSTRYM
What excipients (inactive ingredients) are in XELSTRYM?	XELSTRYM excipients list
DailyMed Link:	XELSTRYM at DailyMed

See drug prices for XELSTRYM

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

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

215401

Dosage:

SYSTEM;TRANSDERMAL

^*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 XELSTRYM

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

US Patents and Regulatory Information for XELSTRYM

XELSTRYM is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

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
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-004	Mar 22, 2022		RX	Yes	Yes
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-001	Mar 22, 2022		RX	Yes	No			Y
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-003	Mar 22, 2022		RX	Yes	No			Y
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-004	Mar 22, 2022		RX	Yes	Yes			Y

International Patents for XELSTRYM

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

Country	Patent Number	Title	Estimated Expiration
Peru	20060491	DISPOSITIVO TRANSDERMICO DE TRANSMISION DE FARMACO QUE INCLUYE UN REFUERZO OCLUSIVO
Mexico	2007004315	DISPOSITIVO PARA SUMINISTRO TRANSDERMICO DE FARMACO QUE INCLUYE UN RESPALDO OCLUSIVO. (TRANSDERMAL DRUG DELIVERY DEVICE INCLUDING AN OCCLUSIVE BACKING.)
European Patent Office	4274555	COMPOSITIONS TRANSDERMIQUES D'AMPHÉTAMINE À FAIBLES TAUX DE CARBAMATE (TRANSDERMAL AMPHETAMINE COMPOSITIONS WITH LOW LEVELS OF CARBAMATE)
Spain	2596809

XELSTRYM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XELSTRYM

Introduction to XELSTRYM

XELSTRYM is a dermal patch formulation designed for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). It was launched in June 2023 by Hisamitsu Pharmaceutical Co., Inc., in collaboration with Noven Pharmaceuticals in the US[1].

Market Context: CNS Stimulant Drugs

The central nervous system (CNS) stimulant drugs market, which includes treatments for ADHD, is experiencing significant growth. This market is forecast to increase by USD 6,486.71 million from 2022 to 2027, at a Compound Annual Growth Rate (CAGR) of 5.8%[4].

Key Drivers of Market Growth

Rise in Incidence of CNS Disorders

The increasing prevalence of CNS disorders such as ADHD, narcolepsy, and sleep apnea is a major driver of the market. In the US, for example, approximately 6.1 million children were diagnosed with ADHD in 2016, contributing to the growing demand for CNS stimulants[4].

Approval of New Stimulants

The approval and launch of new stimulants, including XELSTRYM, are crucial for market growth. These new formulations offer improved efficacy and convenience, attracting more patients and healthcare providers[4].

Increasing Use of Stimulants Worldwide

The global use of stimulants is on the rise, driven by better diagnosis and treatment options. This trend is particularly strong in North America, which is expected to account for 43% of the market growth during the forecast period[4].

Financial Trajectory for XELSTRYM

Sales Performance

Since its launch in June 2023, XELSTRYM has contributed to the increased sales revenue for Hisamitsu Pharmaceutical Co., Inc. The company reported increased sales and profits for two consecutive periods, partly due to the promotional costs and sales structure strengthening for XELSTRYM in the US[1].

Promotional and Advertising Costs

Significant investments have been made in sales promotion and advertising for XELSTRYM. These costs are reflected in the increased Selling, General, and Administrative (SG&A) expenses, which rose by 36.5% in the Q1 FY02/2025 results[1].

Market Expansion

The launch of XELSTRYM has been part of Hisamitsu's strategy to strengthen its sales structure in the US. This includes expanding disease awareness and providing information through academic conferences and commercials, which began airing in June 2024[1].

Competitive Landscape

Market Concentration

The CNS stimulant drugs market is relatively concentrated, with a few large players dominating the market. Companies like Hisamitsu Pharmaceutical Co., Inc. are focusing on expanding their product portfolios through research and development and strategic collaborations[4].

Collaboration and Licensing

Hisamitsu's collaboration with Noven Pharmaceuticals for the launch of XELSTRYM is an example of the strategic partnerships common in this market. These collaborations help in penetrating the global market and enhancing brand value[1][2].

Economic Implications of Precision Medicines

The development of precision medicines, such as XELSTRYM, has significant economic implications. These drugs often target smaller patient populations but can generate substantial value and profits due to their high pricing and limited competition from generics[3].

Regional Analysis

North America

North America, particularly the US, is a key market for CNS stimulant drugs, including XELSTRYM. The region's high prevalence of ADHD and other CNS disorders, along with the easy availability of stimulants, drives market growth in this area[4].

Challenges and Opportunities

Geopolitical Risks and Supply Chain Disruptions

Despite the positive market dynamics, companies face geopolitical risks and supply chain disruptions. Hisamitsu Pharmaceutical Co., Inc. has acknowledged these challenges and is working to maintain a robust financial base and continuous investment in growth initiatives[2].

ESG and Sustainability

The company is also focusing on Environmental, Social, and Governance (ESG) initiatives, which include reducing package sizes and enhancing energy conservation. These efforts contribute to sustainable growth and brand reputation[2].

Key Takeaways

• Market Growth: The CNS stimulant drugs market, including XELSTRYM, is expected to grow significantly due to the rise in CNS disorders and the approval of new stimulants.
• Financial Performance: XELSTRYM has contributed to increased sales and profits for Hisamitsu Pharmaceutical Co., Inc., with significant investments in promotional and advertising costs.
• Competitive Landscape: The market is concentrated with large players focusing on product portfolio expansion and strategic collaborations.
• Economic Implications: Precision medicines like XELSTRYM generate substantial value and profits due to high pricing and limited generic competition.
• Regional Focus: North America, particularly the US, is a crucial market for XELSTRYM due to high prevalence rates of ADHD and other CNS disorders.

FAQs

1. What is XELSTRYM used for? XELSTRYM is a dermal patch formulation used for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

2. When was XELSTRYM launched? XELSTRYM was launched in June 2023.

3. What are the key drivers of the CNS stimulant drugs market? The key drivers include the rise in incidence of CNS disorders, approval of new stimulants, and increasing use of stimulants worldwide.

4. How is the market for CNS stimulant drugs expected to grow? The market is forecast to increase by USD 6,486.71 million from 2022 to 2027, at a CAGR of 5.8%.

5. What are the significant costs associated with the launch of XELSTRYM? Significant investments have been made in sales promotion and advertising costs, contributing to increased SG&A expenses.

Cited Sources

1. Hisamitsu Pharmaceutical Co., Inc. - Q1 FY02/2025 Results.
2. Hisamitsu Pharmaceutical Co., Inc. - Integrated Report 2022.
3. National Bureau of Economic Research - The Economics of Drug Development: Pricing and Innovation in a Changing Market.
4. PR Newswire - Central nervous system (CNS) stimulant drugs market size to grow by USD 6,486.71 million between 2022 and 2027.