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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Istradefylline has forty-nine patent family members in seventeen countries.

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

Summary for ISTRADEFYLLINE

International Patents:	49
US Patents:	2
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
What excipients (inactive ingredients) are in ISTRADEFYLLINE?	ISTRADEFYLLINE excipients list
DailyMed Link:	ISTRADEFYLLINE at DailyMed

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

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 ISTRADEFYLLINE

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

Sponsor	Phase
Georgetown University	Phase 4
Kyowa Kirin, Inc.	Phase 4
Virginia Commonwealth University	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

Paragraph IV (Patent) Challenges for ISTRADEFYLLINE

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 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	022075-002	Aug 27, 2019		RX	Yes	Yes			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			Y
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019		RX	Yes	No			Y

Expired US Patents for ISTRADEFYLLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	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	022075-002	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/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 ISTRADEFYLLINE

Country	Patent Number	Title	Estimated Expiration
Australia	2004275646	Method of stabilizing diarylvinylene compound
South Korea	20060102331	METHOD OF STABILIZING DIARYLVINYLENE COMPOUND
European Patent Office	2044940
Japan	5612016
Japan	2012140461	THERAPEUTIC AGENT FOR DYSKINESIS
Spain	2534220

Market Dynamics and Financial Trajectory for Istradefylline

Last updated: March 4, 2026

What are the market drivers influencing Istradefylline?

Istradefylline is a selective adenosine A2A receptor antagonist approved for Parkinson's disease management. Its market dynamics hinge on the following factors:

• Unmet Medical Need in Parkinson's Disease: A growing global prevalence of Parkinson’s (estimated 6.1 million cases in 2016, expected to reach 12 million by 2040) creates persistent demand for adjunct therapies [1].
• Innovative Mechanism of Action: Unlike traditional dopaminergic therapies, Istradefylline targets the adenosine pathway, offering potential benefits for patients with motor fluctuations.
• Regulatory Approvals: Approved by the U.S. Food and Drug Administration (FDA) in 2019, and by the European Medicines Agency (EMA) in 2020, in combination with levodopa. The approval scope influences market access.
• Competitive Landscape: Limited to a few drugs (e.g., safinamide, opicapone), Istradefylline's niche status positions it in a specialized market segment.

How does Istradefylline's regulatory status affect its market potential?

• United States: FDA approval in 2019 for adjunctive use in Parkinson's patients meeting specific criteria broadens the prescribed population.
• Europe: EMA approval in 2020 expands access, though local reimbursement policies influence actual uptake.
• Japan: Market presence since 2013, with ongoing evaluations for off-label uses.

What are the financial trends influencing Istradefylline's revenue?

• Sales Figures: Estimated global sales in 2022 ranged between $50 million and $75 million, primarily driven by North America and Japan. Data limited due to lack of public disclosures from the manufacturer.
• Market Penetration: Limited to specialized neurology clinics; widespread adoption remains contingent on reimbursement policies and prescriber awareness.
• Pricing Strategy: Avg. wholesale price (AWP) per capsule estimated at $8, with higher pricing in Japan due to extended patent protections and local regulatory conditions.
• Patent Status: Patents protect Istradefylline until 2030, influencing market exclusivity and pricing power.
• Pipeline and launches: No significant pipeline developments or new formulations announced, potentially constraining long-term growth.

What are the key challenges and opportunities shaping the future?

Challenges

• Strict regulatory and reimbursement hurdles in major markets reduce accessible patient populations.
• Competition from other adjunct PD therapies limits market expansion.
• Limited clinical data on long-term safety and efficacy slows adoption.

Opportunities

• Growing Parkinson's prevalence elevates anticipated demand.
• Combination therapies expanding treatment options could increase market share.
• Potential for use in other neurological disorders that involve adenosine pathways.

What is the projected financial trajectory?

• Short-term (2023-2025): Revenues may grow at a compound annual growth rate (CAGR) of 8-12%, driven by increased prescribing as awareness improves.
• Mid-term (2026-2030): Market saturation likely, with revenues plateauing around $100-$120 million depending on market expansion and pricing strategies.
• Long-term (post-2030): Revenue decline expected with patent expiry unless new formulations or indications are introduced.

How does regional variation influence revenue forecasts?

Region	2022 Revenue Estimate	Key Factors
North America	~$30 million	Strong neurology infrastructure, FDA approval, insurance reimbursement
Europe	~$15 million	EMA approval, variable reimbursement policies
Japan	~$10 million	Early adoption, high treatment rates, local regulations
Rest of World	<$10 million	Limited access, regulatory hurdles, emerging markets

Key Takeaways

• Istradefylline benefits from a niche position in Parkinson’s therapy, with steady growth prospects driven by demographic trends.
• Market expansion depends on regulatory approvals and reimbursement policies, which remain variable across regions.
• Revenue growth is constrained by limited clinical data, competition, and patent expiry timelines.
• Strategic opportunities include expanding indications and optimizing pricing in key markets.

FAQs

1. What is the primary indication for Istradefylline?
   Treatment of Parkinson’s disease as an adjunct to levodopa in patients experiencing motor fluctuations.

2. When did regulatory agencies approve Istradefylline?
   The FDA approved it in 2019, and the EMA followed in 2020.

3. What is the expected patent expiry date?
   Patents extend until approximately 2030, assuming no extensions or legal challenges.

4. Are there alternative therapies to Istradefylline?
   Yes, including safinamide, opicapone, and COMT inhibitors, which target similar symptomatic pathways.

5. What factors could accelerate Istradefylline’s market growth?
   Additional approved indications, positive long-term safety data, and expanded reimbursement coverage.

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References

[1] Dorsey, E. R., et al. (2018). Global, regional, and national burden of Parkinson's disease, 1990–2016: a systematic analysis. The Lancet Neurology, 17(11), 939–950.