CLINICAL TRIALS PROFILE FOR ROTIGOTINE

All Clinical Trials for ROTIGOTINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00135993 ↗	Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome	Completed	UCB Pharma	Phase 3	2005-05-01	Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial. The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine. Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).
NCT00136045 ↗	Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome	Completed	UCB Pharma	Phase 3	2005-05-01	The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless leg syndrome (RLS). Additional objectives are to investigate the safety and tolerability of rotigotine. The primary variables are the absolute change from Baseline in the International Restless Legs Severity Scale (IRLS) sum score and Clinical Global Impression-Global Improvement (CGI) Item 1 (severity of illness) score at the end of the Maintenance Period. Subjects will be randomized to receive either placebo, 2.25, 4.5 or 6.75 mg/day rotigotine in a 1:1:1:1 (active:placebo) fashion. Approximately 450 subjects will be enrolled in this trial, participating at approximately 50 sites. The maximum duration of the trial is approximately 8 months (3-week Titration Period, 6-month Maintenance Period, 7-day Taper Period, and 30-day Safety Follow-Up Period). Subjects who complete the 6-month Maintenance Period will be eligible to participate in an open-label extension trial. Subjects who do not complete the 6-month Maintenance Period or who choose not to participate in the open-label extension trial will complete a 3-day Safety Follow-Up Period. Two different patch sizes will be used (5 and 10 cm2). Active patches will contain either 2.25mg (5cm2) or 4.5mg (10cm2) of rotigotine.
NCT00242008 ↗	A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease	Completed	UCB Pharma	Phase 3	2004-12-01	The purpose of this trial is to assess whether it is possible for subjects with idiopathic Parkinson's Disease to switch from ropinirole, pramipexole and cabergoline to rotigotine transdermal system (SPM 962) overnight without worsening of Parkinson's Disease symptoms. Subjects who meet eligibility criteria will be switched overnight to treatment with rotigotine transdermal patches at a dose considered equivalent to the dose of dopamine agonist that the subject is currently taking. Subjects on ropinirole or pramipexole will take their last dose at bedtime and then apply rotigotine patch(es) upon awakening the next morning. Subjects on cabergoline will apply rotigotine patches 24 hours after the final dose of cabergoline. Subjects will continue rotigotine treatment for 28 days, during which dose can be increased or decreased as needed. At the end of treatment, subjects can select to enroll in an open-label extension trial. The first subject was enrolled on 28 December 2004. The last subject was enrolled in June 2005 and the last subject visit was conducted in July 2005. This study is now closed.
NCT00243217 ↗	Rotigotine Restless Legs Syndrome Dose Finding Trial	Completed	UCB Pharma	Phase 2	2003-04-01	The objective of this trial is to demonstrate clinical efficacy of four different dosages of SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15 cm2 patch size respectively) in RLS subjects. It is anticipated that rotigotine (SPM 936) will be more effective than placebo. The tolerability and safety of rotigotine will be assessed.
NCT00243945 ↗	A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease	Completed	UCB Pharma	Phase 3	2004-12-01	The objective of this trial is to assess the effect of rotigotine (SPM 962) on the control of early morning motor impairment and sleep disorders in subjects with idiopathic PD. Subjects who meet eligibility criteria will begin treatment with rotigotine transdermal patches. Trial medication will be titrated to an optimal daily dose, or to the maximal dose. Following a Titration period of up to 8 weeks, subjects will be maintained on the optimal or maximal dose for 4 weeks. After the Maintenance period, subjects will have the option to enter into an open-label extension study. The first subject was enrolled in December 2004. The last subject was enrolled in April 2005 and the last subject visit was conducted in July 2005. This study is now closed

Clinical Trial Conditions for ROTIGOTINE

Condition Name

Condition Name for ROTIGOTINE
Intervention	Trials
Parkinson's Disease	22
Restless Legs Syndrome	14
Idiopathic Parkinson's Disease	8
Parkinson Disease	8

Condition MeSH

Condition MeSH for ROTIGOTINE
Intervention	Trials
Parkinson Disease	48
Syndrome	20
Psychomotor Agitation	19
Restless Legs Syndrome	19

Clinical Trial Locations for ROTIGOTINE

Trials by Country

Trials by Country for ROTIGOTINE
Location	Trials
United States	253
Germany	34
Italy	17
Canada	9
United Kingdom	9

Trials by US State

Trials by US State for ROTIGOTINE
Location	Trials
Florida	22
California	17
North Carolina	16
Texas	13
New York	13

Clinical Trial Progress for ROTIGOTINE

Clinical Trial Phase

Clinical Trial Phase for ROTIGOTINE
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	2
Phase 4	11

Clinical Trial Status

Clinical Trial Status for ROTIGOTINE
Clinical Trial Phase	Trials
Completed	67
Terminated	5
Recruiting	4

Clinical Trial Sponsors for ROTIGOTINE

Sponsor Name

Sponsor Name for ROTIGOTINE
Sponsor	Trials
UCB Pharma	40
UCB BIOSCIENCES GmbH	9
Otsuka Pharmaceutical Co., Ltd.	8

Sponsor Type

Sponsor Type for ROTIGOTINE
Sponsor	Trials
Industry	75
Other	24
NIH	2

Rotigotine clinical trials update, market analysis, and revenue projection (2026–2035)

Last updated: July 24, 2026

Rotigotine (transdermal dopamine agonist; brand focus: Neupro) is transitioning from late-stage life-cycle expansion to a more fragmented long-term pipeline where incremental reformulations and new-dose regimens compete for share rather than changing the therapeutic standard. Market growth is constrained by generic erosion risk outside patent-protected geographies, while uptake in Parkinson’s disease (PD) and restless legs syndrome (RLS) remains the primary demand engine.

Metric	Bottom line
Core indications	Parkinson’s disease (early and advanced, monotherapy or adjunct), Restless legs syndrome
Primary delivery	Transdermal rotigotine system (once-daily)
Near-term pipeline shape	Predominantly incremental studies and life-cycle programs; fewer transformative Phase 3 reads in recent years
Market exposure drivers	PD prevalence, guideline uptake of transdermals, payer preference for once-daily adherence, RLS seasonality and chronicity
Key downside	Patent expiration and generic penetration risk in major markets; margin compression after generic entry

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What is the current clinical trials landscape for rotigotine (Phase 1–Phase 4)?

Rotigotine’s clinical activity is dominated by:

1. dose-optimization and regimen refinement in PD,
2. expanded use cases within PD subtypes, and
3. RLS follow-on studies focused on tolerability and durability of response.

Featured snippet: Clinical trial direction
Rotigotine trials have increasingly shifted toward comparative tolerability endpoints, real-world adherence proxies, and incremental efficacy readouts rather than new mechanism discovery. Trial activity concentrates in PD (including early vs advanced cohorts) and RLS.

How do PD trials typically structure rotigotine endpoints?

Common endpoint families include:

• motor symptom scales (PD-specific composite measures),
• off-time reduction in advanced PD,
• quality-of-life instruments,
• sleep and daytime somnolence proxies,
• adverse event burden (especially nausea, orthostatic hypotension, application-site reactions).

How do RLS trials typically structure rotigotine endpoints?

RLS programs usually emphasize:

• symptom severity scales over defined treatment windows,
• relapse or durability of effect across longer maintenance phases,
• discontinuation rates due to adverse events.

What is the trial intensity signal that matters for investors?

For revenue forecasting, the most market-relevant “signal” is not the count of small Phase 2 studies. It is:

• whether any program has a credible path to label expansion that meaningfully increases eligible patient populations, or
• whether a new regimen supports differentiation after generic entry (for example, a higher-precision dosing approach or improved skin tolerance that payers can justify economically).

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Which rotigotine trials are most likely to change label scope or payer behavior?

Label-changing trials in rotigotine historically cluster around:

• PD symptom domain expansion (motor vs non-motor emphasis),
• earlier-line positioning (where guideline updates can expand treated prevalence),
• RLS chronicity and long-term maintenance evidence (where reimbursement often depends on durability).

Featured snippet: Most likely to move the label
Programs that demonstrate durable benefit with reduced treatment discontinuation or improved tolerability are the ones most likely to support payer adoption post-generic entry.

Where label scope can expand without new mechanisms

Rotigotine already covers core PD and RLS indications in most mature markets. “Expansion” commonly means:

• additional patient subgroups,
• formalization of long-term safety or maintenance use,
• subgroup efficacy claims supported by post-hoc or stratified analyses in registration-aligned designs.

What would materially alter the competitive position?

A competitive step-change would be any of:

• superior adherence metrics validated in pragmatic settings,
• lower discontinuation due to skin reactions that reduce real-world wastage,
• a dosing format that reduces titration time or improves tolerability in elderly cohorts.

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What is the market size and growth trajectory for rotigotine worldwide?

Featured snippet: Growth outlook
Rotigotine’s global market is expected to grow modestly in value terms in the near-to-medium term, then face downward pressure from generic penetration in jurisdictions with earlier and broader patent cutoff.

Demand drivers (use-case and patient-flow logic)

• PD prevalence is rising in aging populations.
• RLS remains underdiagnosed, and once diagnosed often becomes long-term, supporting chronic use.
• Transdermal delivery improves adherence in patients with swallowing difficulties or GI intolerance.

Headwinds (pricing and access)

• Generic entry typically compresses net price quickly.
• Payers can shift demand to lower-cost equivalents if clinical equivalence is accepted.
• Application-site reactions can still cause discontinuation, which limits “durability of spend per patient” versus better-tolerated alternatives in some segments.

Market segmentation that matters for forecasting

Rotigotine revenue is best projected by:

1. PD vs RLS mix shift over time,
2. branded vs generic share in each major geography,
3. average net price and reimbursement intensity,
4. persistence (treatment continuation rates) and discontinuation drivers.

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When does rotigotine lose exclusivity in major markets?

This section requires jurisdiction-specific patent and regulatory data to be accurate. Without a verified expiration/patent estate dataset for Neupro (rotigotine) across the relevant geographies and listed products, an exclusivity timeline cannot be produced reliably.

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What patents protect rotigotine (Neupro) and how strong is the estate?

This section requires specific Orange Book listings and validated patent numbers linked to each dosage form and strength to avoid inaccurate legal mapping. Without the underlying patent list and expiration data, an estate-strength assessment would not be decision-grade.

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What is the Orange Book status of rotigotine products in the US?

This section requires current Orange Book lookups by active ingredient, dosage form, and NDA. Without the verified list of patents and their expiry terms, the status cannot be stated accurately.

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What Paragraph IV filings exist for rotigotine, and what is the litigation posture?

A reliable update requires validated filings and docket-level outcomes (Delaware/SDNY/EDTX etc.), plus any settlement or consent judgment terms tied to each ANDA. Without a verified dataset of ANDA Paragraph IV challenges and litigation outcomes, this cannot be produced to a standard suitable for litigation, licensing, or investment decisions.

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How does rotigotine compare with competing dopamine agonists and transdermal alternatives?

Featured snippet: Competitive set
Rotigotine competes primarily within dopaminergic therapy for PD and dopamine agonist therapy for RLS. The competitive differentiation in payer decisions usually centers on:

• adherence (once daily),
• tolerability and discontinuation rates,
• skin tolerability (application-site reactions),
• titration burden and adverse event profiles.

Positioning advantages

• Once-daily transdermal dosing supports adherence in elderly PD patients.
• Avoids GI exposure patterns relevant to nausea.
• Provides stable delivery that can reduce peaks and troughs compared with some oral regimens.

Positioning disadvantages

• Skin reactions remain a meaningful discontinuation risk.
• If generic price compression occurs, differentiation can erode unless outcomes data support higher persistence or lower discontinuation.

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What generic entry risks exist for rotigotine by geography?

This section requires:

• confirmed patent cutoff and regulatory exclusivity dates by market,
• the number and type of ANDA/MAA filings,
• launch timing patterns post-authorization.

Without verified dataset inputs, a geography-by-geography risk map would be incomplete.

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What new formulations of rotigotine are being developed (patch/system variations)?

This section requires a validated pipeline dataset with specific formulation technologies (matrix composition, adhesive systems, skin penetration enhancements), plus trial identifiers for each reformulation program. Without those, the formulation landscape cannot be summarized accurately.

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What manufacturing and IP barriers could delay biosimilar-like entry for rotigotine?

Rotigotine is a small-molecule drug delivered via a transdermal system. “Biosimilar-like entry” is not the right regulatory construct. The entry barriers are instead:

• transdermal system formulation reproducibility,
• bioequivalence sensitivity to skin permeability and adhesive performance,
• stability, device performance, and lot-to-lot consistency.

This requires product-specific device and formulation data to be decision-grade.

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Revenue projection for rotigotine: base case, bull case, bear case (2026–2035)

Because the exclusivity/patent status, generic penetration timing, and current net-price levels are not provided in the prompt, a numeric projection cannot be produced with the precision required for investment or licensing decisions.

Featured snippet: Projection logic (non-numeric)
A decision-grade projection must model:

• branded share decay by geography tied to legal cutoff,
• generic net price erosion curves,
• persistence impacts from tolerability and adherence,
• mix shift between PD and RLS,
• competitive responses from alternative dopaminergic therapies.

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Key Takeaways

• Rotigotine’s clinical program emphasis is still on PD and RLS outcomes and tolerability rather than mechanism-changing breakthroughs.
• Market growth is likely to be modest before the key pressure point: generic penetration and price compression in major markets.
• A decision-grade exclusivity timeline, Paragraph IV map, litigation update, and numeric revenue projection require verified Orange Book/patent and regulatory filing datasets tied to each rotigotine product and strength.

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FAQs

1. Does rotigotine have better real-world adherence than oral dopamine agonists in Parkinson’s disease?
2. Which adverse events most drive discontinuation for rotigotine patches?
3. How do transdermal system performance differences affect bioequivalence for rotigotine generics?
4. What label claims in PD and RLS most influence payer prior authorization decisions for rotigotine?
5. What is the most common market share shift pattern after rotigotine generic entry?

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References

1. (No citable sources were provided in the prompt.)