NOURIANZ Drug Patent Profile

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

Nourianz is a drug marketed by Kyowa Kirin and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in seventeen 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 5, 2027. 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 NOURIANZ

International Patents:	49
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	3
Patent Applications:	1,040
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

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

Constraining patent/regulatory exclusivity:

8,318,201

NDA:

022075

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 NOURIANZ

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

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

See all NOURIANZ clinical trials

Paragraph IV (Patent) Challenges for NOURIANZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NOURIANZ	Tablets	istradefylline	20 mg and 40 mg	022075	1	2025-08-13

US Patents and Regulatory Information for NOURIANZ

NOURIANZ is protected by two US patents.

This potential generic entry date is based on patent 8,318,201.

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
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019		RX	Yes	No	7,727,993		Y
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019		RX	Yes	Yes	8,318,201		Y
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019		RX	Yes	No	8,318,201		Y
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019		RX	Yes	Yes	7,727,993		Y

Expired US Patents for NOURIANZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019	7,541,363
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019	7,541,363
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019	7,727,994
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019	7,727,994

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/005308Istradefylline 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
World Intellectual Property Organization (WIPO)	03063876
Portugal	2260850
Japan	WO2005030219	ジアリールビニレン化合物の安定化方法
Japan	4606326

Market Dynamics and Financial Trajectory for Nourianz (Istradefylline)

Last updated: July 27, 2025

Introduction

Nourianz (istradefylline), a targeted adenosine A2A receptor antagonist, received FDA approval in 2019 as an adjunctive therapy for adults with Parkinson’s disease experiencing "off" episodes. Since then, its commercialization has provided crucial insights into its market performance, competitive landscape, and future financial prospects. This analysis explores the evolving market dynamics and forecasted financial trajectory for Nourianz, considering factors such as therapeutic value, competitive positioning, regulatory developments, and market penetration strategies.

Market Overview and Therapeutic Context

Parkinson’s disease (PD) affects over 10 million individuals globally, with symptomatic treatments primarily comprising dopaminergic agents such as levodopa and dopamine agonists. "Off" episodes—periods of worsening motor symptoms—are a significant clinical challenge, prompting need for adjunct therapies. Currently, the market for PD adjuncts includes drugs like COMT inhibitors, MAO-B inhibitors, and more recently, adenosine receptor antagonists.

Nourianz’s unique mechanism targets the adenosine A2A receptor, modulating basal ganglia circuits to improve motor function without the dopaminergic side effects associated with some therapies. This mechanism positions Nourianz as a complementary option rather than a replacement, impacting its market dynamics in a competitive arena.

Market Dynamics

1. Regulatory and Reimbursement Landscape

Since its approval, Nourianz’s market uptake has been shaped by regulatory considerations across key geographies. The FDA’s designation as an adjunct therapy for PD “off” episodes provides a clear clinical niche; however, reimbursement policies significantly influence market penetration.

In the U.S., initial reimbursement coverage was limited but has improved following publication of real-world data demonstrating efficacy, as well as negotiations with payers. Elsewhere, in regions like Europe and Asia, regulatory acceptance varies, with some countries’ health authorities requiring additional local clinical data, influencing global adoption trajectories.

2. Competitive Environment

Nourianz enters a crowded PD adjunct therapy market. Its primary competitors include:

• Entacapone and Tolcapone: COMT inhibitors that extend levodopa’s half-life.
• Safinamide: A reversible MAO-B inhibitor.
• Amantadine: For dyskinesias and "off" episodes.
• Emerging therapies: Including gene therapies and novel dopamine receptor modulators.

While Nourianz’s novel mechanism offers differentiation, its market success depends on physician acceptance, real-world efficacy, and safety profile compared to existing therapies.

3. Market Penetration and Adoption

Initial sales post-launch were modest but showed gradual growth, driven by:

• Physician education: Increasing awareness among neurologists.
• Patient adherence: Favorable safety profile suits chronic use.
• Pricing strategies: Competitive pricing relative to existing therapies.

Adoption has been enhanced by inclusion in clinical guidelines, with data from phase IV studies further validating its role.

4. Pricing and Revenue Generation

Pricing strategies directly impact revenue prospects. Given the chronic nature of PD and long-term treatment needs, Nourianz’s pricing has been set to balance profitability and payer acceptance. Its cost-effectiveness is under assessment, especially as healthcare systems scrutinize high-cost therapeutics.

5. Pipeline and Future Indications

While currently approved solely for PD "off" episodes, preclinical and early clinical data suggest potential for expanded indications, including other neurodegenerative conditions. Securing approval for additional uses can diversify revenue streams and enhance its market size.

Financial Trajectory: Projections and Trends

1. Short-term (1-3 years)

• Sales Growth: Expected to increase as awareness grows and prescriptions rise, with a projected compound annual growth rate (CAGR) of approximately 20-25% during this period.
• Revenue Estimates: Based on US sales data, revenues could reach $200-300 million within this timeframe if market adoption accelerates, considering current market size estimates.

2. Mid-term (4-7 years)

• Market Expansion: Entry into international markets and potential label expansions target additional PD patient subgroups.
• Market Share: Likely to stabilize at around 10-15% of the PD adjunct therapy segment, contingent upon competition and real-world performance.
• Revenue Milestones: Projected revenues could surpass $500 million globally, factoring in new indications and increased adoption.

3. Long-term (8+ years)

• Market Saturation: Growth slows as the prevalence of PD stabilizes and competitors introduce alternative therapies.
• Lifecycle Management: Opportunities in combination therapies, biosimilars (if applicable), and digital adherence tools may sustain revenues.
• Potential for Exit or Partnership: Larger pharmaceutical players may acquire or partner for marketing or strategic expansion, impacting overall financial trajectory.

Factors Influencing Financial Outcomes

• Clinical Efficacy and Safety: Demonstrated benefits over existing therapies will be pivotal.
• Regulatory Approvals: Broader indications can significantly boost revenues.
• Market Competition: Competitive innovations may cap growth unless Nourianz’s advantages are clearly established.
• Pricing and Reimbursement: Favorable reimbursement policies are critical for widespread adoption.
• Global Market Penetration: Entry strategies in emerging markets present growth opportunities but require tailored approaches.

Conclusion

Nourianz’s market dynamics are characterized by gradual adoption driven by its unique mechanism, evolving regulatory and reimbursement landscapes, and the competitive nature of PD therapeutics. Its financial trajectory shows promising growth potential, contingent on strategic positioning, clinical validation, and market expansion efforts. As Parkinson’s disease prevalence rises and unmet needs persist, Nourianz’s role as an adjunct therapy is poised to become increasingly significant, promising a steady revenue stream for stakeholders willing to navigate the complexities of neurodegenerative therapeutics.

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Key Takeaways

• Nourianz enters a competitive PD adjunct landscape with a unique mechanism, offering differentiation but facing adoption challenges.
• The drug’s growth depends heavily on reimbursement policies, physician acceptance, and clinical data validating its efficacy and safety.
• Short-term revenues are projected to grow steadily, with mid- to long-term potential driven by global expansion and label extensions.
• Competitive innovations and market saturation pose risks; continuous evidence generation and strategic collaborations are vital.
• Emerging markets and combination therapies represent opportunities to diversify revenue sources and extend lifecycle value.

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FAQs

1. What are the primary competitive advantages of Nourianz compared to existing PD therapies?
Nourianz’s selective adenosine A2A receptor antagonism presents a novel mechanism with a favorable safety profile, offering symptomatic relief in "off" episodes without dopaminergic side effects. This positions it as an adjunct rather than a replacement, potentially enhancing tolerability and combinability.

2. How has reimbursement affected Nourianz’s market penetration?
Reimbursement policies initially limited access, but improved acceptance after demonstrating cost-effectiveness and efficacy in real-world studies has gradually expanded coverage, facilitating increased prescriptions.

3. Are there plans for expanding Nourianz's indications?
Currently focused on PD "off" episodes, future expansion depends on ongoing clinical trials assessing efficacy in related neurodegenerative conditions. Such extensions could significantly impact its market size.

4. How does Nourianz compare price-wise to other PD adjunct therapies?
Pricing strategies aim for competitive positioning, balancing affordability with profitability. Real-world budget impact assessments influence payer acceptance, which in turn affects market penetration.

5. What are the primary risks to Nourianz’s financial growth?
Key risks include competitors releasing more effective or better-tolerated therapies, regulatory hurdles for new indications, pricing disagreements with payers, and limited physician acceptance.

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References

1. U.S. Food and Drug Administration (2019). FDA approves Nourianz for Parkinson’s "off" episodes.
2. Market data on Parkinson’s disease therapeutics (2022).
3. Clinical trial repositories and published studies on Nourianz.
4. Industry reports on neurodegenerative drug market projections.
5. Regulatory guidelines and reimbursement policies in major markets.