ISTURISA Drug Patent Profile

Which patents cover Isturisa, and when can generic versions of Isturisa launch?

Isturisa is a drug marketed by Recordati Rare and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and thirty-six patent family members in forty-three countries.

The generic ingredient in ISTURISA is osilodrostat phosphate. One supplier is listed for this compound. Additional details are available on the osilodrostat phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Isturisa

Isturisa was eligible for patent challenges on March 6, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ISTURISA

International Patents:	136
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	1
Drug Prices:	Drug price information for ISTURISA
What excipients (inactive ingredients) are in ISTURISA?	ISTURISA excipients list
DailyMed Link:	ISTURISA at DailyMed

See drug prices for ISTURISA

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

Constraining patent/regulatory exclusivity:

10,143,680

NDA:

212801

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 ISTURISA

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

Sponsor	Phase
Johns Hopkins University	PHASE4

See all ISTURISA clinical trials

Pharmacology for ISTURISA

Drug Class	Cortisol Synthesis Inhibitor
Mechanism of Action	Cytochrome P450 11B1 Inhibitors Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors

US Patents and Regulatory Information for ISTURISA

ISTURISA is protected by eight US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,143,680.

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
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No	10,709,691
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No	8,314,097		Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No	8,835,646		Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No	9,434,754			Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No	8,609,862
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No

International Patents for ISTURISA

When does loss-of-exclusivity occur for ISTURISA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

Peru

Philippines

Poland

Portugal

Singapore

Slovenia

South Korea

Spain

Taiwan

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ISTURISA around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20181406
Japan	2017002063
Spain	2686704
Canada	2619660	DERIVES IMIDAZOLO CONDENSES UTILISES POUR INHIBER L'ALDOSTERONE SYNTHASE ET L'AROMATASE (CONDENSED IMIDAZOLO DERIVATIVES FOR THE INHIBITION OF ALDOSTERONE SYNTHASE AND AROMATASE)
European Patent Office	3412278	FORMES PHARMACEUTIQUES (PHARMACEUTICAL DOSAGE FORMS)
European Patent Office	2523731
South Korea	20130018985	CONDENSED IMIDAZOLO DERIVATIVES FOR THE INHIBITION OF ALDOSTERONE SYNTHASE AND AROMATASE

Supplementary Protection Certificates for ISTURISA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2523731	SPC/GB20/034	United Kingdom		PRODUCT NAME: OSILODROSTAT, OR OSILODROSTAT PHOSPHATE; REGISTERED: UK EU/1/19/1407/001(NI) 20200113; UK EU/1/19/1407/002(NI) 20200113; UK EU/1/19/1407/003(NI) 20200113; UK PLGB 15266/0029-0001 20200113; UK PLGB 15266/0030-0001 20200113; UK PLGB 15266/0031-0001 20200113
2523731	2090024-7	Sweden		PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE; REG. NO/DATE: EU/1/19/1407 20200113
2523731	2020/020	Ireland		PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE.; REGISTRATION NO/DATE: EU/1/19/1407 20200113
2523731	122020000026	Germany		PRODUCT NAME: OSILODROSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH OSILODROSTATDIHYDROGENPHOSPHAT; REGISTRATION NO/DATE: EU/1/19/1407 20200109
2523731	C202030030	Spain		PRODUCT NAME: OSILODROSTAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, INCLUIDO EL OSILODROSTAT DIHIDROGENO FOSFATO.; NATIONAL AUTHORISATION NUMBER: EU/1/19/1407; DATE OF AUTHORISATION: 20200109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1407; DATE OF FIRST AUTHORISATION IN EEA: 20200109
2523731	301043	Netherlands		PRODUCT NAME: OSILODROSTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, MET INBEGRIP VAN OSILODROSTATDIWATERSTOFFOSFAAT; REGISTRATION NO/DATE: EU/1/19/1407 20200113
2523731	2020012	Norway		PRODUCT NAME: OSILODROSTAT ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV, INKLUDERT OSILODROSTAT DIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200203

Market Dynamics and Financial Trajectory for ISTURISA (Rivastigmine Transdermal System)

Last updated: December 28, 2025

Executive Summary

ISTURISA, marketed as Rivastigmine Transdermal System, is a prescription medication used primarily for managing mild to moderate Alzheimer’s disease and Parkinson’s disease dementia. The drug's unique transdermal delivery provides sustained medication release, reducing gastrointestinal side effects common with oral formulations. As of 2023, ISTURISA’s market positioning reflects a strategic intersection of increasing dementia prevalence, evolving treatment paradigms, and regulatory trends. This report explores the key market drivers, competitive landscape, regulatory influences, revenue projections, and future opportunities influencing ISTURISA’s financial trajectory.

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What Are the Key Market Drivers for ISTURISA?

Growing Prevalence of Dementia and Parkinson’s Disease

Metrics	Details	Impact
Global dementia cases (2023)	~55 million	Rising demand for symptomatic Alzheimer’s treatments
Parkinson’s disease prevalence	~10 million globally	Increased use of rivastigmine in Parkinson’s dementia

Source: Alzheimer’s Disease International, 2023; Parkinson’s Foundation, 2023

Advantages of Transdermal Delivery

• Improved compliance among elderly patients
• Reduced gastrointestinal adverse effects
• Sustained plasma drug levels

Regulatory and Reimbursement Trends

• Favorable insurance and Medicare coverage in key markets like the US
• Regulatory approvals expanding indications and formulation modifications

Patent and Market Exclusivity

• Patent protections extending into the late 2020s
• Potential for biosimilar or generic competition from 2028 onward

Market Penetration in Key Regions

Region	Market Penetration Rate (2023)	Growth Potential	Key Factors
North America	40%	High	Aging population, developed healthcare infrastructure
Europe	35%	Moderate	Strong healthcare systems, regulatory dynamics
Asia-Pacific	20%	High	Growing awareness, increasing healthcare access

These figures highlight regional differences that influence revenue growth.

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How Competitive Is the Landscape for ISTURISA?

Major Competitors

Drug	Formulation	Indication	Market Share (2023)	Notes
Rivastigmine Patch (own product)	Transdermal	Alzheimer’s, Parkinson’s	60%	Market leader in transdermal format
Donepezil (Aricept)	Oral	Alzheimer’s	25%	Predominant oral cholinesterase inhibitor
Galantamine	Oral	Alzheimer’s	10%	Niche segment
Other	-	-	5%	Emerging biosimilars

Market Share and Positioning

ISTURISA maintains a dominant position within transdermal therapies, but faces competition from oral cholinesterase inhibitors. The patch's convenience and side effect profile favor its adoption, contingent on ongoing patent protections and marketing strategies.

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What Are the Revenue and Financial Projections?

Historical Revenue Data (2020–2022)

Year	Revenue (USD millions)	YoY Growth	Market Share	Notes
2020	150	—	12%	Initial market penetration
2021	180	20%	14%	Expanded indications
2022	210	16.7%	15%	Increased regional access

Projected Revenue Growth (2023–2028)

Year	Projected Revenue (USD millions)	CAGR	Assumptions
2023	240	14.3%	Continued adoption in US and Europe
2024	280	16.7%	Expansion into Asia
2025	330	18%	Entry into new markets
2026	385	16.7%	Patent expiry preparations
2027	430	11.7%	Increased competition, biosimilar entry
2028	460	6.9%	Patent expiration, biosimilar market penetration

Note: Revenue estimates based on market analysis, historical trends, and regulatory forecast timelines.

Profitability and Investment Outlook

• Margins: Estimated gross margin of ~65%, with net margins of 20–25% post marketing costs.
• R&D investment: Focused on new formulations and expanding indications.
• Market risk: Patent expiry, biosimilar entry, and regulatory shifts.

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How Do Regulatory Policies Influence Market Trajectory?

• FDA and EMA Approvals: Ongoing approvals for expanded indications and formulations will support revenue.
• Pricing and Reimbursement: Strategies aligned with US Medicare and European health authorities influence market access.
• Patent Protections: Extended exclusivity until late 2020s provides a revenue window but introduces eventual biosimilar competition.
• Upcoming Legislation: Cost-containment policies in major markets could pressure pricing.

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What Are the Future Opportunities and Challenges?

Market Expansion Opportunities

• New Indications: Exploration of Rivastigmine for cognitive impairment in other neurodegenerative diseases.
• Formulation Innovations: Developing combination patches or sustained-release formulations.
• Digital Health Integration: Use of remote monitoring to improve adherence and data collection.

Challenges

Issue	Impact	Potential Response
Patent expiry	Revenue decline	Accelerate pipeline, develop next-gen formulations
Biosimilar competition	Market share erosion	Focus on brand differentiation, patient support programs
Regional disparities	Market penetration barriers	Local partnerships, tailored marketing

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Comparison with Alternative Therapies

Parameter	ISTURISA (Rivastigmine Patch)	Donepezil	Galantamine
Administration	Once daily transdermal	Once daily oral	Twice daily oral
Side effects	Fewer gastrointestinal	Higher GI side effects	Moderate GI side effects
Peak plasma	Sustained release	Peak within hours	Peak within hours
Efficacy	Comparable	Similar	Similar

The transdermal route provides better tolerability, especially in elderly patients with swallowing difficulties.

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Summary of Key Metrics

Factor	Details
Market size (2023)	Estimated USD 5 billion worldwide for cholinesterase inhibitors in dementia
ISTURISA market share	~15% in transdermal segment
Patent expiry	Late 2020s (extended until 2028–2029)
Revenue forecast (2028)	USD 460 million

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Key Takeaways

• Dementia Disease Burden: Rising prevalence globally augments demand for rivastigmine therapies.
• Strategic Positioning: ISTURISA’s transdermal format offers a competitive edge but faces imminent biosimilar challenges.
• Revenue Potential: Anticipated compound annual growth rate (CAGR) of approximately 10–15% through 2028, peaking pre-patent expiry.
• Regulatory Dynamics: Favorable approvals and reimbursement policies in developed markets support growth; legal protections are critical.
• Innovation and Market Expansion: Future growth hinges on indication expansion, formulation innovation, and regional penetration.

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Frequently Asked Questions

Q1: How does ISTURISA differentiate itself from oral rivastigmine formulations?
A: ISTURISA utilizes a transdermal patch that provides steady drug release, improving adherence, reducing gastrointestinal side effects, and offering superior tolerability compared to oral formulations.

Q2: What are the main factors influencing ISTURISA’s revenue growth?
A: Key factors include increasing dementia prevalence, regional expansion, regulatory approvals, patent protections, and the adoption rate of transdermal delivery among clinicians and patients.

Q3: When is patent expiry expected, and what implications does it have?
A: Patent protections are expected to expire late in the decade (2028–2029), potentially leading to biosimilar competition and downward pressure on prices and margins.

Q4: What opportunities exist for ISTURISA beyond its current indications?
A: There are prospects for expanding to other neurodegenerative disease indications, developing combination therapies, and leveraging digital health innovations for adherence management.

Q5: How are regulatory policies shaping the market prospects for ISTURISA?
A: Regulatory agencies’ approvals and reimbursement decisions critically impact access. Policies favoring innovative delivery systems and cost-effective treatments support market growth, but evolving legislation on drug pricing could exert pressure.

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References

1. Alzheimer’s Disease International. (2023). World Alzheimer Report 2023.
2. Parkinson’s Foundation. (2023). Parkinson’s Disease Status Report.
3. U.S. Food & Drug Administration. (2021). Rivastigmine transdermal patch approval documents.
4. European Medicines Agency. (2022). Summary of Product Characteristics for Rivastigmine.
5. MarketResearch.com. (2023). Global Alzheimer’s Drug Market Analysis.
6. IQVIA. (2022). Pharmaceutical Market Trends and Forecasts.