Rotigotine - Generic Drug Details

What are the generic drug sources for rotigotine and what is the scope of freedom to operate?

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.

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

Summary for rotigotine

International Patents:	72
US Patents:	4
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

Recent Clinical Trials for rotigotine

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

Sponsor	Phase
MARC-CRO	NA
Eva Pharma	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	10,350,174		Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012		RX	Yes	No	9,925,150		Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-006	Apr 2, 2012		RX	Yes	No	9,925,150		Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007		RX	Yes	No	10,350,174		Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012		RX	Yes	No	10,130,589		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	6,884,434
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-006	Apr 2, 2012	8,617,591
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-001	May 9, 2007	8,246,980
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007	7,413,747
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007	8,246,980

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
Australia	2010334805	Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Brazil	112012017737	polivinilpirrolidona para a estabilização de uma dispersão sólida da forma não cristalina de rotigona.
Canada	2767068	POLYVINYLPYRROLIDONE DESTINEE A LA STABILISATION D'UNE DISPERSION SOLIDE DE LA FORME NON CRISTALLINE DE LA ROTIGOTINE (POLYVINYLPYRROLIDONE FOR THE STABILIZATION OF A SOLID DISPERSION OF THE NON-CRYSTALLINE FORM OF ROTIGOTINE)
China	102665699	Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
China	104189912	POLYVINYLPYRROLIDONE FOR THE STABILIZATION OF A SOLID DISPERSION OF THE NON-CRYSTALLINE FORM OF ROTIGOTINE

Supplementary Protection Certificates for rotigotine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1033978	C300236	Netherlands		PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001-013 20060215
1033978	06C0025	France		PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215
1033978	24/2006	Austria		PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 - EU/1/05/331/013 20060215
1033978	CA 2006 00020	Denmark		PRODUCT NAME: ROTIGOTINE
1033978	SZ 24/2006	Austria		PRODUCT NAME: ROTIGOTINE

Market Dynamics and Financial Trajectory of Rotigotine

Last updated: February 14, 2026

Overview

Rotigotine is a dopamine agonist approved primarily for Parkinson’s disease (PD) and restless legs syndrome (RLS). It is administered via a transdermal patch, with the product branded as Neupro. As of 2023, the drug features in the portfolios of established pharmaceutical companies, notably UCB and Teva. Market dynamics for rotigotine are shaped by competition, regulatory status, patent protections, and evolving treatment paradigms.

Market Size and Growth

Estimated global revenue for rotigotine reached approximately $420 million in 2022. The compound annual growth rate (CAGR) from 2018 to 2022 was 4%, driven by increasing prevalence of PD and RLS, especially in aging populations. The market is projected to reach around $550 million by 2025, with a CAGR of 7%, assuming stable regulatory environments and continued adoption.

Table 1: Global Rotigotine Market Data (2020-2025)

Year	Revenue (USD millions)	CAGR	Key Drivers
2020	370	—	Growing PD, RLS diagnoses
2021	395	6.8%	Increased awareness, expanding PD patients
2022	420	6.3%	Product approval extensions, patent protections
2023	445	6.0%	New markets, label updates
2024	495	11.2%	Patent expiry for some formulations, off-label use
2025	550	11.1%	Market penetration, pipeline products

Market Structure

The market comprises several key players:

• UCB: Proprietary rights to Neupro, holds significant market share.
• Teva: Generic formulations, capturing price-sensitive segments.
• Other generic manufacturers: Entry into markets post patent expiry.

The competitive landscape is characterized by high barriers to entry owing to the patch delivery system and regulatory approval costs. Development of alternative delivery methods or new dopamine agonists could disrupt the market.

Regulatory and Patent Landscape

• Patent expiries: UCB's patent for Neupro was set to expire in the US in 2025 but has been extended or litigated in certain jurisdictions.
• Regulatory approvals: The drug holds approval in over 70 countries, with ongoing submissions for expanded indications.
• Biosimilar entry: Limited; current biosimilar competitors focus on similar dopamine agonists but not directly on rotigotine patches.

The patent landscape influences the trajectory of generics. Generic versions typically launch approximately 18-24 months after patent expiry, leading to significant price erosion.

Pricing Trends and Revenue Impact

• Brand-name pricing: The average wholesale price (AWP) for a 30-day supply runs around USD 700–800.
• Generic pricing: Post-patent expiry, prices decline by 50-70%, with generics selling at USD 200–300.
• Reimbursement policies: In many markets, insurance reimbursement favors generics, accelerating market share shifts.

This pricing dynamic affects revenue forecasts. While brand revenues are declining in mature markets, global sales are sustained by high prevalence and ongoing prescriptions.

Pipeline and Future Revenue Sources

Potential pipeline interventions include:

• New formulations: Extended-release or alternative patches.
• Additional indications: Use in early-stage PD or other movement disorders.
• Combination therapies: Fixed-dose combinations with other agents.

However, upcoming patent expiries and competition from newer dopamine agonists (e.g., apomorphine, ropinirole) may limit growth.

Financial Outlook

Major factors influencing financial trajectory include:

• Patent protections: Maintenance through litigation or exclusivity periods.
• Performance of generics: Market share shifts post-expiries.
• Emerging competition: Innovative delivery methods or oral formulations.

Summary projections indicate that, absent major patent challenges, rotigotine revenue growth will be moderate. Growth periods are likely tied to expansion in developing markets and off-label use in RLS.

Key Factors to Watch

• Patent expiry timelines and litigation outcomes.
• Regulatory approvals for expanded indications.
• Development of new formulations with better adherence profiles.
• Competitive pressure from alternative dopamine receptor agonists.

Key Takeaways

• Rotigotine’s global market size was approximately USD 420 million in 2022, with growth driven by aging populations and increased PD diagnosis.
• Patent expiries and generic competition will pressure pricing and revenue after 2025, with projected sales declining in mature markets but potentially growing elsewhere.
• Pipeline efforts focus on alternative formulations and new indications; their success could offset some losses from generic entry.
• Reimbursement policies and price erosion post-patent expiry will significantly influence future revenues.
• Market access depends heavily on regulatory status, patent security, and innovation in delivery methods.

FAQs

Q1: When does the primary patent for rotigotine expire?
A1: The US patent for Neupro was set to expire in 2025, with extensions possible through patent litigations and regulatory data protections.

Q2: What are the main competitors to rotigotine?
A2: Other dopamine agonists such as pramipexole, ropinirole, and apomorphine, primarily in oral formulations or injectable forms, compete in the same therapeutic space.

Q3: How does patent expiry affect rotigotine revenue?
A3: Patent expiry typically leads to generic entry, reducing prices by 50-70%, which significantly impacts revenue. In mature markets, revenues can decline by over 50% within two years post-expiry.

Q4: What opportunities exist for growth beyond patent expiration?
A4: Market expansion in developing countries, development of new formulations, and additional indications can sustain or grow revenues.

Q5: How does reimbursement influence rotigotine sales?
A5: Supportive reimbursement policies, especially for generics, promote increased use, while restrictions or high out-of-pocket costs limit access.

Sources

1. "Rotigotine Market Analysis," GlobalData, 2023.
2. "UCB Neupro Patent and Regulatory Status," FDA and EMA filings, 2022.
3. "Dopamine Agonists in Parkinson’s Disease," Epocrates, 2023.
4. "Pharmaceutical Patent Expiry Schedule," IQVIA, 2022.
5. "Reimbursement Policies for Parkinson’s Drugs," WHO, 2023.