Rotigotine - Generic Drug Details

What are the generic 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 five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rotigotine has ninety-eight patent family members in thirty-one countries.

There are seven drug master file entries for rotigotine. One supplier is listed for this compound.

Summary for rotigotine

International Patents:	98
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	85
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rotigotine
What excipients (inactive ingredients) are in rotigotine?	rotigotine excipients list
DailyMed Link:	rotigotine at DailyMed

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.

Recent Clinical Trials for rotigotine

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

Sponsor	Phase
Eva Pharma	NA
MARC-CRO	NA
University Hospital, Rouen	PHASE2

See all rotigotine clinical trials

Pharmacology for rotigotine

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine Agonists

Anatomical Therapeutic Chemical (ATC) Classes for rotigotine

N04BC	Dopamine agonists
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

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	021829-005	Apr 2, 2012		RX	Yes	No			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012		RX	Yes	No			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007		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	021829-002	May 9, 2007
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-001	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
Mexico	PA05000349	SISTEMA MEJORADO DE ENTREGA TRANSDERMAL. (IMPROVED TRANSDERMAL DELIVERY SYSTEM.)
Japan	4837916
European Patent Office	1386605	Systeme transdermique ameliore pour l'administration de rotigotin (Improved transdermal delivery system for the administration of rotigotine)

Supplementary Protection Certificates for rotigotine

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ROTIGOTINE

Last updated: July 28, 2025

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Introduction

Rotigotine, a non-ergoline dopamine agonist, is predominantly employed in the management of Parkinson’s disease and restless legs syndrome (RLS). Its unique transdermal delivery system distinguishes it from oral formulations, providing continuous dopaminergic stimulation that is critical for symptom control in these chronic neurodegenerative disorders. Understanding the current market dynamics and the potential financial trajectory of rotigotine involves analyzing its therapeutic profile, competitive landscape, regulatory environment, and market opportunities.

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Therapeutic Profile and Market Demand

Rotigotine's mechanism involves stimulating dopamine receptors (primarily D3, D2, and D1), mitigating the dopaminergic deficits characteristic of Parkinson’s disease. Its transdermal patch provides a steady release, reducing adverse effects linked to peak plasma concentrations typical in oral medications. This delivery system enhances patient compliance and quality of life, factors driving its adoption.

The global Parkinson’s disease market is projected to reach USD 9.4 billion by 2027, growing at a CAGR of approximately 5.4% (Fortune Business Insights[1]). RLS is also increasingly diagnosed, with prevalence estimates around 10% in certain populations, further expanding rotigotine’s potential patient base.

Market demand remains robust, especially as aging populations globally lead to higher neurodegenerative disease prevalence. However, the shift towards dopamine agonists with improved safety and efficacy profiles, including rotigotine, positions it favorably within treatment paradigms.

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Competitive Landscape and Market Position

Rotigotine faces competition primarily from oral dopamine agonists such as pramipexole and ropinirole, as well as newer agents including safinamide and innovative therapies like gene-based approaches. Despite oral alternatives, the transdermal route confers advantages in maintaining plasma drug levels and reducing motor fluctuations.

Key players include UCB Pharma, which markets the branded patch Neupro, approved by the FDA and numerous other regulatory agencies. While patent protection historically provided market exclusivity, patent expirations and the advent of generic formulations are influencing market dynamics.

Generics and Pricing:
Following patent expiry, generic rotigotine formulations are expected to significantly impact sales volumes and pricing. Market analysts anticipate aggressive pricing strategies from biosimilar manufacturers, which could reduce drug prices by 20-40%, intensifying competition.

Regulatory and Reimbursement Factors:
Coverage policies in major markets like the US and EU influence market penetration. Positive reimbursement decisions facilitate patient access, bolstering revenue streams. Conversely, rejection or restrictive policies may limit market reach.

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Regulatory Environment and Licensing Trends

Regulatory pathways in key regions—FDA (US), EMA (Europe), and PMDA (Japan)—dictate approval timing and labeling updates. Recent approvals have focused on expanding indications from Parkinson’s disease to RLS, broadening market potential.

In 2019, the FDA approved a new transdermal formulation of rotigotine for Parkinson’s, emphasizing continued innovation. Ongoing clinical trials aim to establish neuroprotective roles, which could materially alter the market outlook if successful.

Patents for rotigotine are nearing expiry in key markets, with UCB Pharma’s patent rights set to expire around 2024–2026 in multiple regions. This timing presents both challenges and opportunities: erosion of exclusivity vs. the chance to capture a larger market share through cheaper generics.

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Market Opportunities and Challenges

Opportunities:

• Expansion into emerging markets with rising healthcare infrastructure, such as China, India, and Brazil.
• Development of combination therapies leveraging rotigotine’s mechanism, potentially enhancing efficacy.
• Incorporation into personalized medicine strategies, aligning treatment with genetic and biomarker profiles.
• Ongoing research into neuroprotection and disease modification could create new indications.

Challenges:

• Competition from oral dopamine agonists with similar efficacy at lower costs.
• Side effect profile, including nausea, hallucinations, and impulse control disorders, may limit use in certain populations.
• Patent expirations exacerbate pricing pressures, risking margin erosion.
• Regulatory hurdles for new formulations and indications can delay market expansion.

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Financial Trajectory and Forecast Analysis

The financial outlook for rotigotine hinges on multiple interdependent variables: patent status, competitive pressure, regulatory approvals, and market uptake.

Short-Term (Next 2 Years):

• Patent expiries will likely precipitate a steep decline in revenue in established markets.
• Increased adoption of generics could halve current prices, reducing revenue by 30-50%.
• Continued sales through existing formulations, especially in developing markets, will support steady revenue streams.

Medium to Long-Term (3-7 Years):

• Market share stabilization depends on whether companies innovate or diversify formulations.
• Potential new indications, such as neuroprotective effects, could restore growth trajectories if validated.
• Strategic partnerships and licensing agreements with regional manufacturers may bolster revenues.

Scenario Analysis:

• Pessimistic: Heavy generic competition and regulatory delays lead to a 50-70% revenue decline.
• Optimistic: Successful pipeline development and regulatory approvals lead to a renewed revenue stream, with CAGR approaching 3-5%.
• Base Case: Moderate decline post-patent expiry, with revenues stabilizing at approximately 50-60% of peak levels, supported by expanding markets and formulation innovations.

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Implications for Stakeholders

For pharmaceutical companies, investing in formulation enhancements and new indications is vital to sustain and grow market share for rotigotine. Licensing opportunities and strategic alliances can facilitate expansion into emerging markets. Payers and healthcare providers must evaluate cost-effectiveness, especially as biosimilars become more prevalent.

Investors should monitor patent landscapes, clinical pipeline developments, and market penetration strategies, as these directly influence revenue forecasts. Companies that effectively manage patent expiry risks and innovate within the therapeutic space will position for a resilient financial trajectory.

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Key Takeaways

• Rotigotine's transdermal delivery confers clinical advantages but faces pricing pressure due to impending patent expiries.
• Market growth relies on expanding indications, emerging market penetration, and pipeline innovations focused on neuroprotection.
• Competition from oral dopamine agonists and biosimilars will influence pricing and market share.
• Strategic licensing, formulation advancements, and regulatory clearances represent critical levers for future revenue growth.
• Stakeholders must balance short-term patent-related revenue decline with long-term growth strategies driven by innovation and market expansion.

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FAQs

1. How will patent expirations affect rotigotine’s market share?
Patent expirations will likely lead to generic entry, significantly reducing prices and profit margins. Companies must innovate or secure new indications to sustain revenue.

2. Are biosimilars a threat or an opportunity for rotigotine?
Biosimilars pose competitive threats by offering lower-cost alternatives. However, they also present licensing opportunities and potential collaborations to expand market reach.

3. What are the main challenges in expanding rotigotine's indications beyond Parkinson's disease?
Clinical validation of neuroprotective effects and regulatory approvals are critical. Without proven efficacy and regulatory clearance, expansion remains limited.

4. How important are emerging markets for rotigotine’s future growth?
Highly significant; rising neurodegenerative and sleep disorder prevalence, coupled with increasing healthcare infrastructure, offers substantial growth opportunities.

5. What strategies can companies adopt to extend rotigotine’s market viability?
Investing in formulation innovation, developing combination therapies, expanding indications, and building regional partnerships are vital strategies.

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References

1. Fortune Business Insights. “Parkinson’s Disease Market Size, Share & Industry Analysis, 2022-2027.”