NEUPRO Drug Patent Profile

When do Neupro patents expire, and what generic alternatives are available?

Neupro is a drug marketed by Ucb Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in NEUPRO is rotigotine. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rotigotine profile page.

DrugPatentWatch^® Generic Entry Outlook for Neupro

Neupro was eligible for patent challenges on May 9, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 1, 2032. This may change due to patent challenges or generic licensing.

There have been twelve patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NEUPRO

International Patents:	98
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	41
Patent Applications:	1,654
Drug Prices:	Drug price information for NEUPRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEUPRO
What excipients (inactive ingredients) are in NEUPRO?	NEUPRO excipients list
DailyMed Link:	NEUPRO at DailyMed

See drug prices for NEUPRO

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

NDA:

021829

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 NEUPRO

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

Sponsor	Phase
Eva Pharma	NA
MARC-CRO	NA
Virginia Commonwealth University	Phase 2

See all NEUPRO clinical trials

Pharmacology for NEUPRO

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine Agonists

Paragraph IV (Patent) Challenges for NEUPRO

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 NEUPRO

NEUPRO is protected by six US patents.

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
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007		RX	Yes	No			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-006	Apr 2, 2012		RX	Yes	No			Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007		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	021829-005	Apr 2, 2012		RX	Yes	No			Y

Expired US Patents for NEUPRO

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
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012

EU/EMA Drug Approvals for NEUPRO

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 NEUPRO

See the table below for patents covering NEUPRO around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	200204148	Transdermal therapeutic systems with improved stability and a method for the production thereof.
Mexico	2012007326	POLIVINILPIRROLIDONA PARA LA ESTABILIZACION DE UNA DISPERSION SOLIDA DE FORMA NO CRISTALINA DE ROTIGOTINA. (POLYVINYLPYRROLIDONE FOR THE STABILIZATION OF A SOLID DISPERSION OF THE NON-CRYSTALLINE FORM OF ROTIGOTINE.)
South Korea	20170023772	비결정질형 로티고틴의 고체 분산체의 안정화를 위한 폴리비닐피롤리돈 (POLYVINYLPYRROLIDONE FOR THE STABILIZATION OF A SOLID DISPERSION OF THE NON-CRYSTALLINE FORM OF ROTIGOTINE)
Spain	2256780
Denmark	2515887

Supplementary Protection Certificates for NEUPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1033978	06C0025	France		PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215
1033978	CA 2006 00020	Denmark		PRODUCT NAME: ROTIGOTINE
1033978	24/2006	Austria		PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 - EU/1/05/331/013 20060215
1033978	SZ 24/2006	Austria		PRODUCT NAME: ROTIGOTINE
1033978	SPC026/2006	Ireland		SPC026/2006:, EXPIRES: 20210214

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NEUPRO (Rotigotine)

Last updated: July 27, 2025

---

Introduction

NEUPRO, a transdermal patch delivering rotigotine, is a dopaminergic agent primarily prescribed for Parkinson’s disease and restless legs syndrome (RLS). Since its approval in 2006, NEUPRO has carved a significant niche within neurodegenerative disorder therapeutics, with its unique delivery mechanism and patient-centric benefits. This report explores the evolving market dynamics, competitive landscape, pipeline prospects, and the financial trajectory influencing NEUPRO’s positioning within the pharmaceutical industry.

---

Market Overview and Therapeutic Landscape

Parkinson’s Disease and RLS: Growing Prevalence

Parkinson’s disease affects over 10 million individuals globally, with an anticipated compound annual growth rate (CAGR) of approximately 4% through 2030, driven by aging populations in developed markets[^1]. Restless legs syndrome impacts around 7-10% of adults, with variations across demographics. The expanding patient base underscores persistent demand for efficacious dopaminergic therapies, including rotigotine.

Current Treatment Paradigm

Dopamine agonists like rotigotine occupy a critical position in early and advanced Parkinson’s management, often used alone or adjunctively with levodopa[^2]. NEUPRO’s transdermal system offers continuous drug delivery, circumventing gastrointestinal absorption variability, reducing peak-trough fluctuations, and potentially improving compliance[^3].

Competitive Landscape

The landscape comprises oral dopamine agonists (pramipexole, ropinirole), monoamine oxidase-B inhibitors, and emerging pharmacotherapies, including gene and cell therapies. Notably, rotigotine faces competition from newer formulations with improved pharmacokinetics or targeted mechanisms, as well as from non-dopaminergic agents under development[^4].

---

Market Dynamics

Regulatory and Reimbursement Environment

Patent expirations, such as that of the original formulation in 2021, influence market dynamics significantly. While NEUPRO’s patent cliff opens opportunities for biosimilars or generics, regulatory pathways for biosimilar approval remain complex in many jurisdictions, affecting market entry timing[^5]. Reimbursement policies also shape adoption; countries with favorable formulary considerations bolster NEUPRO’s sales, especially where transdermal delivery reduces caregiver burden.

Pricing and Cost-Effectiveness

Pricing strategies for NEUPRO have historically positioned it as a premium therapy, justified by its convenience and adherence advantages. Cost-effectiveness analyses, incorporating reduced hospitalization due to better symptom control, favor its sustained use in certain markets[^6].

Technological Innovation and Pipeline Developments

The success of NEUPRO hinges on the maintenance of technological relevance. Innovations like extended-release formulations or combination devices could modify the competitive landscape. Moreover, pipeline drugs targeting similar pathways or employing novel delivery systems—such as implantable devices—pose both threats and opportunities.

Market Penetration and Adoption Drivers

Physician familiarity with rotigotine, clinical guidelines endorsing dopaminergic agents, and patient preference for patch delivery drive market adoption. However, concerns regarding skin reactions and cost can impede penetration in certain demographics.

---

Financial Trajectory and Revenue Projections

Historical Sales and Financial Performance

Since its launch, NEUPRO has experienced fluctuating revenues, influenced by patent status, generic competition, and market acceptance. In 2022, global sales approximated $400 million, with North America and Europe accounting for over 70% of revenue[^7].

Impact of Patent Expiry and Generics

The patent expiration in several key jurisdictions introduced generic competitors, exerting downward pressure on prices and revenues. Nonetheless, brand loyalty, physician prescribing habits, and patient preferences for transdermal delivery sustained residual sales.

Growth Opportunities

Emerging markets represent a lucrative avenue owing to rising Parkinson’s prevalence and limited existing treatments. Strategic marketing, cost-effective pricing, and local regulatory approvals could catalyze sales growth exceeding the global CAGR of the disease population. Moreover, expanding indications—such as additional neuropsychiatric disorders—may unlock further revenue streams.

Forecasting Future Revenue Streams

Analysts project a moderate CAGR of 3-5% over the next five years for NEUPRO, contingent on:

• Patent protection status and successful defense against biosimilar threats.
• Product pipeline success or alternative delivery system innovations enhancing adherence.
• Market expansion into emerging economies with increasing disease prevalence.

In scenarios where biosimilars penetrate markets aggressively, revenues could decline by up to 20-30%. Conversely, innovation-driven differentiation may sustain or increase sales.

Strategic M&A and Portfolio Synergies

Acquisitions of marketing rights or alliances with local manufacturers could bolster NEUPRO’s market reach. Additionally, integration within multi-modal treatment packages enhances overall value, supporting premium pricing strategies.

---

Risk Factors and Market Challenges

• Regulatory hurdles for biosimilars and new formulations.
• Market commoditization due to rising generic competition.
• Adverse event profile, especially skin reactions, impacting tolerability and adherence.
• Shifts in clinical guidelines favoring alternative therapies or non-dopaminergic agents.

---

Conclusion

NEUPRO’s market dynamics reflect a confluence of demographic trends, technological innovation, regulatory frameworks, and competitive pressures. Its financial trajectory hinges on strategic patent management, pipeline advancements, and market expansion efforts. While facing challenges from generics and evolving treatment paradigms, NEUPRO maintains a critical role within the Parkinson’s and RLS therapeutic landscape, with potential for moderate growth driven by technological adaptation and geographic diversification.

---

Key Takeaways

• Expanding Patient Base: Increasing Parkinson’s prevalence ensures ongoing demand for dopaminergic therapies like NEUPRO.
• Patent and Competition: Patent expirations necessitate proactive strategies to counter generic erosion, including innovation and market differentiation.
• Market Expansion: Emerging markets and underserved demographics offer growth opportunities, contingent on regulatory navigation and localized marketing.
• Pipeline and Innovation: Advancements such as extended-release patches or combination devices may reinforce NEUPRO’s market position.
• Regulatory and Reimbursement Strategies: Navigating complex approval pathways and securing favorable reimbursement terms are critical for sustained revenues.

---

FAQs

1. How does NEUPRO compare to oral dopamine agonists in efficacy and tolerability?
NEUPRO offers continuous dopamine delivery via transdermal patches, potentially reducing motor fluctuations and improving compliance. Tolerability profiles are comparable, though skin reactions may occur. Its efficacy in symptom control aligns with oral formulations, with some patients preferring its ease of use.

2. What are the major threats to NEUPRO’s market share?
The primary threats include biosimilar entry post-patent expiration, advent of newer formulations with enhanced pharmacokinetics, and non-dopaminergic therapies gaining guideline prominence.

3. Can NEUPRO’s revenue benefit from pipeline innovations?
Yes. Novel delivery systems, combination therapies, or new indications could enhance sales, extend product lifecycle, and improve competitive positioning.

4. How significant are regulatory challenges for NEUPRO’s future growth?
Regulatory hurdles mainly concern biosimilar approvals and safety profile management. Clear pathways and robust safety data support market continuity, though unpredictability remains.

5. What strategies should companies pursue to maximize NEUPRO’s commercial potential?
Focus on geographic expansion, pipeline innovation, patient adherence programs, and strategic partnerships will be pivotal in maximizing long-term profitability.

---

References

[^1]: GlobalData. Parkinson’s Disease Market Analysis, 2022.
[^2]: Lieberman, A., et al. "Management of Parkinson's Disease." The Lancet, 2019.
[^3]: Cummings, J., et al. "Drug Delivery in Parkinson’s Disease." Neuropharmacology, 2018.
[^4]: EU Clinical Trials Register. "Emerging Parkinson's Therapies." 2022.
[^5]: U.S. FDA. Biosimilar Approval Process Overview, 2022.
[^6]: Health Economics Journal. "Cost-effectiveness of Rotigotine Patches in Parkinson's Disease," 2021.
[^7]: Company Annual Reports, 2022.

---

End of Article

This comprehensive analysis aims to support strategic decision-making for stakeholders invested in NEUPRO’s market evolution and financial prospects.