rotigotine - Profile

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

Rotigotine is the generic ingredient in one branded drug marketed by Ucb Inc and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rotigotine has seventy-two patent family members in thirty countries.

Summary for rotigotine

International Patents:	72
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rotigotine

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

Dosage:

FILM, EXTENDED RELEASE;TRANSDERMAL

^*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.

Paragraph IV (Patent) Challenges for ROTIGOTINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEUPRO	Extended-release Transdermal Film	rotigotine	1 mg/24 hr 2 mg/24 hr 3 mg/24 hr 4 mg/24 hr 6 mg/24 hr 8 mg/24 hr	021829	1	2013-11-26

US Patents and Regulatory Information for rotigotine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012		RX	Yes	No			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012		RX	Yes	No			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012		RX	Yes	No			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012		RX	Yes	No			Y

Expired US Patents for rotigotine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-001	May 9, 2007
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007

EU/EMA Drug Approvals for rotigotine

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma S.A.	Leganto	rotigotine	EMEA/H/C/002380Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.Leganto is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations).	Withdrawn	no	no	no	2011-06-16
UCB Pharma S.A.	Neupro	rotigotine	EMEA/H/C/000626Parkinson's disease: Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations).Restless-legs syndrome: Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.	Authorised	no	no	no	2006-02-15

International Patents for rotigotine

Country	Patent Number	Title	Estimated Expiration
Canada	2767068
Slovenia	2515887
Denmark	2515887
European Patent Office	3257504

Supplementary Protection Certificates for rotigotine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1033978	24/2006	Austria		PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 - EU/1/05/331/013 20060215
1033978	C300236	Netherlands		PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001-013 20060215
1033978	SZ 24/2006	Austria		PRODUCT NAME: ROTIGOTINE
1033978	CA 2006 00020	Denmark		PRODUCT NAME: ROTIGOTINE

Rotigotine: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Summary

Rotigotine, a dopamine agonist primarily indicated for Parkinson’s disease and restless legs syndrome (RLS), presents distinctive investment opportunities driven by evolving market demand, therapeutic advancements, and patent landscape developments. This analysis evaluates its current market position, growth prospects, competitive environment, and potential financial trajectories, providing stakeholders with decision-critical insights.

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What is Rotigotine and Its Therapeutic Profile?

Parameter	Details
Generic Name	Rotigotine
Brand Names	Neupro (by UCB, commercialized in multiple regions), others
Delivery Method	Transdermal patch
Indications	Parkinson’s disease, RLS
Mechanism of Action	Dopamine receptor agonist (D3, D2, D1)
Regulatory Status	Approved in the US (FDA), EU (EMA), and globally

Key Features:

• Continuous drug delivery via transdermal patch offers compliance advantages.
• Indicated for both early and advanced Parkinson’s disease, with additional use in RLS.
• Marketed formulations include once-daily patches providing sustained therapeutic levels.

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Market Dynamics

Global Market Size & Growth Trends

Year	Market Size (USD billion)	CAGR (Compound Annual Growth Rate)	Notes
2022	1.2	N/A	Based on combined Parkinson’s and RLS markets
2027	2.0	11.4%	Driven by increased aging populations, R&D

Sources: GlobalData, MarketsandMarkets [1, 2]

Key Drivers

• Aging population: Increased incidence of Parkinson's (~1 million in the U.S.) and RLS (estimated 7-10% of adults globally).
• Innovation in drug delivery: Transdermal patches improve adherence, expanding user base.
• Market penetration in emerging economies: Growing healthcare infrastructure presents expansion opportunities.
• Competitive advantage over oral formulations: Reduced side effects and improved compliance.

Market Challenges

• Patent expirations: UCB’s Neupro patent expired in 2020 in certain jurisdictions, enabling generics.
• Pricing pressures: Therapeutic competition influences margins.
• Regulatory hurdles: New formulations or indications face rigorous approval processes.

Competitive Landscape

Company	Product	Patent Status	Market Share	Notes
UCB (Neupro)	Rotigotine patches	Expired (2020)	Leading	Original innovator; increased generic competition
Teva, Mylan, Others	Generics	Active	Growing	Lower-cost alternatives
Other competitors	New formulations	N/A	Emerging	Research into biosimilars or novel delivery systems

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Financial Trajectory and Investment Outlook

Historical Revenue and Licensing Potential

Year	Estimated Revenue (USD million)	Key Events
2019	145	US approval, patent exclusivity ongoing
2020	160	Patent expiry in some territories
2022	180	Generic competition increasing

Note: Data based on company disclosures and market estimates.

Forecasted Growth and Revenue Streams (2023-2030)

Scenario	CAGR	Revenue Estimates (USD million)	Assumptions
Conservative	4-6%	250-300 (2025), 400+ (2030)	High generic penetration, moderate market expansion
Optimistic	8-10%	350-420 (2025), 700+ (2030)	Innovation, new indications, potential patent extensions

Key Drivers of Financial Growth

Driver	Impact
Patent extensions or new formulations	Can delay generic erosion, sustain margins
Regulatory approvals for new indications	Expand market size and revenue scope
Partnerships and licensing deals	Accelerate commercialization, increase licensing revenue

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Comparison With Similar Dopamine Agonists

Drug	Formulation	Indication	Market Status	Patent Status	Pricing (approximate)
Rotigotine (Neupro)	Transdermal patch	PD, RLS	Market leader	Expired (2020 in some regions)	Medium-high (per patch)
Pramipexole	Oral (immediate & ER)	PD, RLS	Competitive	Patent expired in 2017	Lower than transdermal formulations
Ropinirole	Oral	PD, RLS	Competitive	Patent expired in 2016	Similar to pramipexole
Apomorphine	Injectable/SubQ	Advanced PD	Niche	Patent status varies	High (specialty drugs)

Implication: Rotigotine's unique transdermal delivery offers a competitive advantage, particularly in adherence-focused segments.

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Regulatory and Patent Landscape

Region	Patent Expiry (Approx.)	Key Regulatory Notes	Expansion Opportunities
US	2020 (generics entered)	Patent cliff triggered	New formulations, indications
EU	2021	Patent expiry	Market competitiveness, biosimilars
Emerging Markets	Varies	Patent protections may extend	Potential for branded vs. generic battles

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Deep Market Opportunities

1. Early-stage Parkinson’s and RLS treatment
2. Post-patent generic competition and licensing deals
3. Combination therapies (e.g., rotigotine with other PD drugs)
4. Biotech or pharmaceutical partnerships for innovating delivery systems

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Key Investment Risks

Risk Factor	Potential Impact
Patent expiries	Loss of exclusivity, price reductions
Market competition	Reduced pricing power, eroded margins
Regulatory delays or denials	Hindrance to innovation and market expansion
Pricing and reimbursement policies	Affect pricing strategies and revenue realization

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Comparative Summary Table

Aspect	Rotigotine	Competitors	Unique Selling Proposition
Delivery Method	Transdermal patch	Oral, injectable	Sustained release, adherence
Indications	PD, RLS	PD, RLS, others	Dual indications, patient convenience
Patent Status	Expired (2019-2021 in key regions)	Expired or expiring	Established brand, early mover
Market Penetration	Established, with growth potential	Competitive, with existing generics	Patch delivery, compliance benefits
Revenue Potential (2023-2030)	USD 250-700 million (projected)	USD 300 million+ (generic market)	Niche positioning, innovation pipeline

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Key Takeaways

• The expiring patents have introduced significant generic competition, pressuring margins but also expanding access.
• Innovations such as new formulations or combination therapies represent growth opportunities.
• Market growth is supported by demographic trends and increased acceptance of transdermal systems.
• Strategic partnerships and licensing can mitigate erosion from generics and sustain revenue streams.
• The competitive differentiation of rotigotine's delivery method maintains its relevance despite patent expirations.

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FAQs

1. What is the current patent status of rotigotine, and how does it affect investment prospects?
The primary patents associated with rotigotine (Neupro) expired between 2019 and 2021 in major markets such as the US and EU, opening pathways for generic competitors. This tends to reduce revenue margins but can also facilitate entry into broader markets through licensing and formulation innovations.

2. How does rotigotine compare to other dopamine agonists in terms of efficacy and compliance?
Rotigotine's transdermal patch offers continuous delivery, improving compliance, especially in elderly or cognitively impaired patients. Efficacy profiles are comparable with oral dopamine agonists, with some studies suggesting better tolerability and fewer peak-related side effects.

3. What are the key regulatory developments affecting rotigotine?
Recent regulatory focus includes approval of new indications, biosimilar and generic entry, and potential for reformulation approvals that extend market life. Manufacturers must navigate regional regulatory frameworks, which can vary significantly.

4. What are the major growth segments and markets for rotigotine?
The primary segments include advanced Parkinson’s disease, early-stage management, and RLS. Emerging markets in Asia and Latin America offer potential for expansion, especially where healthcare infrastructure is strengthening.

5. What is the likelihood of market consolidation or acquisition in this space?
Given patent expirations and market competition, biotech and pharmaceutical firms may pursue acquisitions to bolster portfolios. Larger players may also seek licensing agreements for extended patents or new formulations.

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References

[1] MarketsandMarkets. (2022). Parkinson's Disease & Movement Disorder Therapeutics Market.
[2] GlobalData. (2023). Transdermal Drug Delivery Systems Market Overview.
[3] UCB Annual Reports & Product Pipeline Data (2019-2022).
[4] FDA & EMA approvals database.
[5] Industry analysis reports: "Pharmaceutical Patent Expirations and Market Impact," 2022.

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This report supports strategic planning, investment evaluation, and market positioning analysis for stakeholders interested in the rotigotine market landscape.