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NEUPRO Drug Patent Profile

When do Neupro patents expire, and when can generic versions of Neupro launch?

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 eighty-nine patent family members in thirty 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:	89
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	39
Patent Applications:	1,283
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
Virginia Commonwealth University	Phase 2
National Institute on Drug Abuse (NIDA)	Phase 2
I.R.C.C.S. Fondazione Santa Lucia	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

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	021829-003	May 9, 2007
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-001	May 9, 2007

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/002380 Leganto 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/000626 Parkinson'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
China	104189912	POLYVINYLPYRROLIDONE FOR THE STABILIZATION OF A SOLID DISPERSION OF THE NON-CRYSTALLINE FORM OF ROTIGOTINE
Norway	20050472
Germany	50003145

Supplementary Protection Certificates for NEUPRO

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	SPC026/2006	Ireland		SPC026/2006:, EXPIRES: 20210214
1033978	SZ 24/2006	Austria		PRODUCT NAME: ROTIGOTINE

NEUPRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NEUPRO

Overview of NEUPRO

NEUPRO, also known as rotigotine, is a non-ergot dopamine agonist formulated as an extended-release transdermal patch. It is indicated for the treatment of Parkinson’s disease (PD) and restless legs syndrome (RLS)[1][4][5].

Market Indications and Usage

NEUPRO is approved for use in any stage of Parkinson’s disease, including early and advanced stages, and for moderate-to-severe restless legs syndrome. This broad indication makes it a versatile treatment option in the neurology market[4][5].

Competitive Landscape

The Parkinson’s disease market is highly competitive, with several established and emerging therapies. NEUPRO competes with other dopamine agonists such as pramipexole and ropinirole. Despite its unique transdermal delivery system, NEUPRO faces challenges from generic versions of these competitors, which can impact its market share and pricing[4].

Financial Performance

Revenue Trends

In recent years, NEUPRO has experienced declining net sales in several key markets, including the U.S. and Japan. This decline is partly due to the competitive market environment and the impact of generic erosion. For instance, UCB reported stable net sales for NEUPRO in Europe but declining sales in the U.S. and international markets, particularly in Japan[2].

Cost and Pricing

The cost of NEUPRO is generally higher compared to its generic competitors. Pharmacoeconomic analyses have shown that NEUPRO is more expensive than generic pramipexole and ropinirole in various scenarios. The price of NEUPRO would need to be significantly reduced to be cost-equivalent to these generics[4].

Revenue Impact

The revenue from NEUPRO contributes to UCB’s overall financial performance, although it is not as significant as some of UCB’s other products like CIMZIA and BRIVIACT. The decline in NEUPRO sales has been offset to some extent by the growth of other products in UCB’s portfolio[2].

Market Growth and Projections

Parkinson’s Disease Market

The Parkinson’s disease market is expected to grow at a CAGR of 5.8% from 2020 to 2034, driven by advancements in diagnostic techniques, increased awareness, and a robust emerging pipeline of late-stage drugs. This growth could potentially benefit NEUPRO, although it will depend on how well the drug competes with new and existing therapies[3].

Emerging Therapies

The approval of new therapies such as Supernus Pharmaceuticals/Britannia Pharmaceuticals' SPN-830, AbbVie's tavapadon, and Pharma Two B's P2B001 could significantly impact the market dynamics. These new treatments may offer alternative options for patients, potentially affecting NEUPRO’s market share[3].

Financial Modeling and Valuation

Net Present Value (NPV) Model

Evaluating the financial trajectory of NEUPRO involves complex financial modeling, including NPV analysis. GlobalData’s NPV model provides a comprehensive tool for forecasting and valuing pharmaceutical assets like NEUPRO. This model considers factors such as revenue and cost forecasts, patent law, regulatory approvals, and cash flows to derive the NPV of the drug[1].

Operating Profit and Cash Flow

The NPV model includes a forecasted revenue model, operating profit model, net profit calculation, and discounted cash flow analysis. These components help in understanding the expected profitability and cash flow generation from NEUPRO over a 17-year forecast period[1].

Challenges and Opportunities

Generic Erosion

One of the significant challenges facing NEUPRO is generic erosion, particularly in markets like the U.S. and Japan. Generic versions of competing drugs can significantly reduce the market share and pricing power of NEUPRO[2][4].

Regulatory and Market Approval

NEUPRO has faced regulatory challenges in the past, such as its temporary withdrawal from the U.S. market due to issues with crystallization in the patch. Ensuring regulatory compliance and maintaining market approval is crucial for its continued success[5].

Pipeline Development

While NEUPRO is not currently under development for new indications, its manufacturer, UCB, is actively involved in developing other innovative therapies. This pipeline activity can help mitigate the impact of declining sales of NEUPRO by offering new revenue streams[2].

Key Takeaways

• Market Indications: NEUPRO is approved for Parkinson’s disease and restless legs syndrome, offering a broad range of treatment options.
• Competitive Landscape: Faces competition from generic dopamine agonists, impacting its market share and pricing.
• Financial Performance: Experiencing declining net sales in key markets due to generic erosion and competitive pressures.
• Market Growth: The Parkinson’s disease market is expected to grow, but new therapies may impact NEUPRO’s market share.
• Financial Modeling: NPV models are essential for evaluating the financial trajectory and valuation of NEUPRO.

FAQs

What is NEUPRO used for?

NEUPRO (rotigotine) is used for the treatment of Parkinson’s disease and restless legs syndrome.

Why did NEUPRO face a temporary withdrawal from the market?

NEUPRO was temporarily withdrawn from the U.S. market due to issues with crystallization in the patch, which could have led to under-dosing.

How does NEUPRO compare to other dopamine agonists in terms of cost?

NEUPRO is generally more expensive than generic pramipexole and ropinirole.

What is the expected growth rate of the Parkinson’s disease market?

The Parkinson’s disease market is expected to grow at a CAGR of 5.8% from 2020 to 2034.

What factors are considered in the NPV model for NEUPRO?

The NPV model considers revenue and cost forecasts, patent law, regulatory approvals, and cash flows to derive the NPV of the drug.

Sources

1. GlobalData: Net Present Value Model: Neupro - GlobalData
2. UCB: Strong first six months – UCB with continued delivery and strong resilience
3. GlobeNewswire: Parkinson's Disease Market is Expected to Showcase a Significant Growth at a CAGR of 5.8% During the Study Period (2020–2034) | DelveInsight
4. CADTH Common Drug Review: CDR Pharmacoeconomic Review Report for Neupro
5. The Medical Letter Inc.: In Brief: Transdermal Rotigotine (Neupro)