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NOURIANZ Drug Patent Profile

When do Nourianz patents expire, and what generic alternatives are available?

Nourianz is a drug marketed by Kyowa Kirin and is included in one NDA. There are three patents protecting this drug.

This drug has sixty-three patent family members in eighteen countries.

The generic ingredient in NOURIANZ is istradefylline. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the istradefylline profile page.

DrugPatentWatch^® Generic Entry Outlook for Nourianz

Nourianz was eligible for patent challenges on August 27, 2023.

Indicators of Generic Entry

Summary for NOURIANZ

International Patents:	63
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	3
Patent Applications:	401
Drug Prices:	Drug price information for NOURIANZ
What excipients (inactive ingredients) are in NOURIANZ?	NOURIANZ excipients list
DailyMed Link:	NOURIANZ at DailyMed

See drug prices for NOURIANZ

Recent Clinical Trials for NOURIANZ

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

Sponsor	Phase
Kyowa Kirin, Inc.	Phase 4
Georgetown University	Phase 4
ALS Association	Phase 1/Phase 2

See all NOURIANZ clinical trials

US Patents and Regulatory Information for NOURIANZ

NOURIANZ is protected by three 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
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
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019		RX	Yes	No

Expired US Patents for NOURIANZ

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

EU/EMA Drug Approvals for NOURIANZ

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 NOURIANZ

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

Country	Patent Number	Title	Estimated Expiration
Mexico	PA04007299	METODOS DE TRATAMIENTO DE PACIENTES QUE SUFREN DE TRASTORNOS DE MOVIMIENTO. (METHODS OF TREATING PATIENTS SUFFERING FROM MOVEMENT DISORDERS.)
European Patent Office	2260850	Antagonistes des récepteurs A2A pour utilisation dans le traitement des troubles du mouvement (A2A receptor antagonists for use in the treatment of movement disorders)
Canada	2813048

Market Dynamics and Financial Trajectory for NOURIANZ

Introduction to NOURIANZ

NOURIANZ, containing the active ingredient istradefylline, is a significant player in the treatment landscape of Parkinson's disease. Here, we delve into the market dynamics and financial trajectory of this drug.

Mechanism of Action and Clinical Significance

NOURIANZ works as an adenosine A2A receptor antagonist, which helps in managing the motor symptoms of Parkinson's disease. Its unique mechanism of action sets it apart from other treatments, making it a valuable option for patients[1].

Market Assessment

The market for NOURIANZ is assessed across seven major markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. This comprehensive assessment includes forecasted sales data from 2024 to 2032, providing insights into the drug's market potential[1][3].

Market Size and Growth

The Parkinson's disease market, in which NOURIANZ operates, is expected to grow significantly. The market size for Parkinson's disease in the 7MM (seven major markets) was USD 3.2 billion in 2023, with a projected CAGR of 5.8% from 2020 to 2034. This growth is driven by advancements in diagnostic techniques, increased awareness, and a rising number of reported cases[4].

Competitive Landscape

NOURIANZ faces competition from both existing and emerging therapies. Other notable treatments include Supernus Pharmaceuticals/Britannia Pharmaceuticals' SPN-830, AbbVie's tavapadon, and Pharma Two B's P2B001. These emerging therapies are expected to significantly impact the market dynamics and challenge NOURIANZ's dominance[4].

Regulatory Milestones and Development Activities

The regulatory and developmental activities surrounding NOURIANZ are crucial for its market trajectory. The drug has undergone various clinical trials, and its regulatory milestones have been closely monitored. The report provides detailed information on trial interventions, trial conditions, and the status of these trials[1].

SWOT Analysis

A SWOT analysis of NOURIANZ highlights its strengths, such as its novel mechanism of action and the growing demand for Parkinson's disease treatments. However, it also faces weaknesses, including the emergence of new competitors and the need for continuous R&D investment. Opportunities lie in the expanding market size and the potential for penetration into new markets, while threats include the intense competition from other therapies[1][3].

Financial Performance and Projections

Revenue and Profit Projections

The financial performance of NOURIANZ is closely tied to its market success. The report forecasts significant revenue growth for NOURIANZ from 2024 to 2032. This growth is expected to be driven by the increasing prevalence of Parkinson's disease and the drug's efficacy in managing its symptoms[1][3].

Impact of Emerging Therapies

The launch of late-stage emerging therapies is expected to impact NOURIANZ's market share. However, the drug's established presence and ongoing R&D activities are likely to help it maintain a competitive edge. The forecasted sales data and SWOT analysis provide valuable insights for decision-making regarding the therapeutic portfolio[1][3].

Company Performance: Kyowa Kirin

Kyowa Kirin, the company behind NOURIANZ, has shown strong financial performance in recent years. In FY2023, Kyowa Kirin reported record profits with revenue growth of 11.6% and a core operating profit increase of 12%. The company's R&D investments and strategic business model adjustments are aimed at sustaining growth and maximizing corporate value[2].

R&D Investments and Growth Strategy

Kyowa Kirin's R&D expenses, although lower than planned in FY2023, are expected to increase as part of the company's growth strategy. The company aims to invest in further growth, supported by its significant cash reserves and a focus on innovative therapies. This strategy is crucial for maintaining NOURIANZ's market position and exploring new therapeutic areas[2].

Market Dynamics: Challenges and Opportunities

Challenges

The Parkinson's disease market is highly competitive, with several emerging therapies poised to enter the market. NOURIANZ must navigate these challenges by continuously improving its therapeutic offerings and expanding its market reach.

Opportunities

The growing prevalence of Parkinson's disease and advancements in healthcare spending present significant opportunities for NOURIANZ. The drug's unique mechanism of action and the company's strong R&D focus position it well to capitalize on these opportunities[1][3].

Future Market Assessments

The future market assessments for NOURIANZ are positive, with forecasted sales data indicating steady growth. The report highlights that the market scenario for Parkinson's disease is set to change due to extensive research and incremental healthcare spending, which will expand the market size and enable drug manufacturers to penetrate more deeply into the market[1][3].

Key Takeaways

• Market Growth: The Parkinson's disease market is expected to grow at a CAGR of 5.8% from 2020 to 2034.
• Competitive Landscape: NOURIANZ faces competition from emerging therapies but maintains a strong market position due to its novel mechanism of action.
• Regulatory and Developmental Activities: Continuous R&D and regulatory milestones are crucial for NOURIANZ's market success.
• Financial Performance: Kyowa Kirin's strong financial performance and R&D investments support NOURIANZ's growth trajectory.
• Market Dynamics: The market is highly competitive, but growing healthcare spending and the drug's efficacy present significant opportunities.

FAQs

What is the active ingredient in NOURIANZ?

NOURIANZ contains istradefylline, an adenosine A2A receptor antagonist.

Which markets are included in the NOURIANZ market assessment?

The market assessment includes the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

What is the projected CAGR for the Parkinson's disease market?

The Parkinson's disease market is expected to grow at a CAGR of 5.8% from 2020 to 2034.

Which companies are developing competing therapies for Parkinson's disease?

Companies such as Supernus Pharmaceuticals, AbbVie, and Pharma Two B are developing competing therapies.

What is the significance of SWOT analysis for NOURIANZ?

The SWOT analysis helps in understanding NOURIANZ's strengths, weaknesses, opportunities, and threats, which are crucial for its market strategy and competitive positioning.

Sources

1. ResearchAndMarkets.com: "NOURIANZ Market Size, Forecast, and Market Insight - 2032"
2. Kyowa Kirin: "Transcript of Results Briefing Fiscal 2023"
3. GlobeNewswire: "NOURIANZ Market Size, Forecast, and Market Insight - 2032"
4. GlobeNewswire: "Parkinson's Disease Market is Expected to Showcase a Significant Growth at a CAGR of 5.8% During the Study Period (2020–2034)"