ISTRADEFYLLINE - Generic Drug Details

What are the generic drug sources for istradefylline and what is the scope of patent protection?

Istradefylline is the generic ingredient in one branded drug marketed by Kyowa Kirin and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Istradefylline has sixty-three patent family members in eighteen countries.

There is one drug master file entry for istradefylline. One supplier is listed for this compound.

Summary for ISTRADEFYLLINE

International Patents:	63
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	25
Patent Applications:	894
What excipients (inactive ingredients) are in ISTRADEFYLLINE?	ISTRADEFYLLINE excipients list
DailyMed Link:	ISTRADEFYLLINE at DailyMed

Recent Clinical Trials for ISTRADEFYLLINE

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

Sponsor	Phase
Georgetown University	Phase 4
Kyowa Kirin, Inc.	Phase 4
Randy Trumbower, PT, PhD	Phase 1/Phase 2

See all ISTRADEFYLLINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ISTRADEFYLLINE

N04CX	Other antiparkinson drugs
N04C	OTHER ANTIPARKINSON DRUGS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for ISTRADEFYLLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019		RX	Yes	No
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019		RX	Yes	Yes			Y
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019		RX	Yes	No			Y
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019		RX	Yes	Yes			Y

Expired US Patents for ISTRADEFYLLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019

EU/EMA Drug Approvals for ISTRADEFYLLINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Kyowa Kirin Holdings B.V.	Nouryant	istradefylline	EMEA/H/C/005308 Istradefylline is indicated in adults as an adjunctive treatment to levodopa based regimens in patients with Parkinson’s disease (PD) experiencing “OFF” time.	Refused	no	no	no		2022-01-06

International Patents for ISTRADEFYLLINE

Country	Patent Number	Title	Estimated Expiration
South Korea	101229594
European Patent Office	1676578	Procédé de stabilisation d'un composé diarylvinylene (Method of stabilizing diarylvinylene compound)
Australia	2004275646	Method of stabilizing diarylvinylene compound
China	1845742	Method of stabilizing diarylvinylene compound

ISTRADEFYLLINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Istradefylline

Introduction

Istradefylline, marketed under the brand names Nourianz and Nouriast, is a selective adenosine A2A receptor antagonist developed by Kyowa Hakko Kirin for the treatment of Parkinson's disease. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its growth prospects, key players, and market trends.

Mechanism of Action and Clinical Significance

Istradefylline works by inhibiting adenosine A2A receptors in the basal ganglia, a region of the brain crucial for motor control and significantly affected in Parkinson's disease. This mechanism helps maintain a balance in dopamine action, reducing "off-time" episodes in patients with Parkinson's[2][4].

Market Growth and Projections

The Istradefylline API market is expected to experience significant growth between 2024 and 2031, with a remarkable CAGR. This growth is driven by increasing demand for effective treatments for Parkinson's disease, a condition with a growing global prevalence. Market Research Pulse predicts substantial market size increases during this period, making it an attractive segment for investors and stakeholders[1].

Key Players and Market Share

Several companies are prominent in the Istradefylline API market, including:

• Hunan Huateng Pharmaceutical
• Zhejiang Ausun Pharmaceutical
• Transo-Pharm
• TATEYAMA KASEI
• Kyowa Pharma Chemical
• OUCHI SHINKO CHEMICAL INDUSTRIAL

Kyowa Hakko Kirin, the developer of istradefylline, holds a significant market share due to its early mover advantage and extensive R&D resources[1][4].

Regulatory Approvals and Global Expansion

Istradefylline was first approved in Japan in March 2013 under the brand name Nouriast. It received FDA approval in the United States in August 2019 under the brand name Nourianz. The drug is currently undergoing the approval process in the European Union, which is expected to further expand its global reach[2][4].

Financial Performance

Kyowa Kirin's sales of istradefylline have been robust, particularly in Japan, where the drug has generated around 10 billion yen annually. The global market for Parkinson's disease treatment, valued at around 240 billion yen, presents a significant opportunity for istradefylline to capture a larger market share[4].

Market Trends and Drivers

The market for istradefylline is driven by several key trends:

• Increasing Prevalence of Parkinson's Disease: The growing number of patients with Parkinson's disease globally is a major driver.
• Innovative Mechanism of Action: Istradefylline's unique mechanism of targeting adenosine A2A receptors sets it apart from traditional dopaminergic therapies.
• Global Expansion: The ongoing approval process in new regions is expected to boost sales and market presence.
• Research and Development: Continuous R&D efforts by companies like Kyowa Kirin to develop new treatments for Parkinson's disease are likely to enhance the market[1][2][4].

Challenges and Opportunities

Despite the positive outlook, the market faces several challenges:

• Adverse Effects: Common adverse reactions include dyskinesia, hallucinations, and lack of impulse control, which require careful patient monitoring[2][3].
• Regulatory Hurdles: The approval process in new regions can be lengthy and complex.
• Competition: Emerging treatments and generic alternatives could pose competition in the future.

However, these challenges also present opportunities for innovation and differentiation. For instance, improving patient adherence through targeted interventions can enhance the drug's effectiveness and patient outcomes[5].

SWOT Analysis

A SWOT analysis of key market players highlights their strengths, weaknesses, opportunities, and threats:

• Strengths: Early mover advantage, strong R&D capabilities, and established market presence.
• Weaknesses: Dependence on a single product, potential for adverse effects.
• Opportunities: Global expansion, increasing demand for Parkinson's treatments.
• Threats: Regulatory challenges, emerging competitors[1].

Manufacturing and Supply Chain

The manufacturing process for istradefylline involves a detailed cost analysis, rates of consumption and production, and import/export status. The supply chain assessment is crucial for ensuring consistent quality and availability of the drug. Companies like Kyowa Kirin have invested heavily in their manufacturing capabilities to meet growing demand[1].

Consumer Preferences and Behavior

The market insights indicate a shift in consumer preferences towards more effective and innovative treatments for Parkinson's disease. Patients and healthcare providers are increasingly looking for therapies that can reduce "off-time" episodes and improve motor control, making istradefylline a preferred choice[1].

Economic Scenarios and Market Data

The economic indicators influencing the growth of the Istradefylline API market include market size, revenue, supply and demand dynamics, and macro-economic factors. The report by Market Research Pulse provides detailed market data and economic scenarios to help stakeholders make informed decisions[1].

Conclusion

The market dynamics and financial trajectory of istradefylline are characterized by significant growth potential, driven by its unique mechanism of action, increasing global demand, and ongoing regulatory approvals. Despite challenges such as adverse effects and regulatory hurdles, the opportunities for expansion and innovation are substantial. As the global market for Parkinson's disease treatment continues to evolve, istradefylline is poised to play a major role.

Key Takeaways

• Growing Market: The Istradefylline API market is expected to grow significantly between 2024 and 2031.
• Unique Mechanism: Istradefylline's action on adenosine A2A receptors sets it apart from traditional Parkinson's treatments.
• Global Expansion: Approvals in new regions are expanding the drug's global reach.
• Financial Performance: Robust sales in Japan and growing global revenue.
• Challenges and Opportunities: Adverse effects and regulatory challenges present both risks and opportunities for innovation.

FAQs

What is the primary mechanism of action of istradefylline?

Istradefylline works by inhibiting adenosine A2A receptors in the basal ganglia, helping to maintain a balance in dopamine action and reduce "off-time" episodes in Parkinson's disease patients[2].

Which company developed istradefylline?

Istradefylline was developed by Kyowa Hakko Kirin in Japan[2][4].

What are the common adverse effects of istradefylline?

Common adverse reactions include dyskinesia, hallucinations, and lack of impulse control[2][3].

In which regions is istradefylline currently approved?

Istradefylline is approved in Japan and the United States and is undergoing the approval process in the European Union[2][4].

What is the expected market growth for istradefylline between 2024 and 2031?

The Istradefylline API market is expected to grow at a remarkable CAGR between 2024 and 2031, driven by increasing demand and global expansion[1].

Sources

1. Market Research Pulse: Istradefylline API Market Trends, Scope And Outlook.
2. DrugBank: Istradefylline: Uses, Interactions, Mechanism of Action.
3. Tandfonline: Safety and effectiveness of istradefylline in patients with Parkinson's disease.
4. Kyowa Kirin: KIRIN CSV REPORT 2020 (English).
5. PubMed: Adherence to istradefylline in patients with Parkinson's disease.