ROTIGOTINE - Generic Drug Details

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

Rotigotine has eighty-nine 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:	89
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:	81
Patent Applications:	2,960
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

Constraining patent/regulatory exclusivity:

6,884,434

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
National Institute on Drug Abuse (NIDA)	Phase 2
Virginia Commonwealth University	Phase 2
Hoffmann-La Roche	Phase 1

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	9,925,150		Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012		RX	Yes	No	8,246,980		Y
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007		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	021829-003	May 9, 2007	7,413,747
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012	6,884,434
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-001	May 9, 2007	6,699,498

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/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 ROTIGOTINE

Country	Patent Number	Title	Estimated Expiration
Portugal	1524971
South Korea	20050056942	IMPROVED TRANSDERMAL DELIVERY SYSTEM FOR THE ADMINISTRATION OF ROTIGOTINE
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	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	CA 2006 00020	Denmark		PRODUCT NAME: ROTIGOTINE

ROTIGOTINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rotigotine

Introduction

Rotigotine, a non-ergoline dopamine agonist, is a crucial medication for the treatment of Parkinson’s disease (PD) and Restless Legs Syndrome (RLS). The market dynamics and financial trajectory of rotigotine are influenced by several factors, including its therapeutic efficacy, market competition, and regulatory environments.

Therapeutic Efficacy and Indications

Rotigotine is approved for the treatment of PD and RLS in Europe and the United States. Its transdermal delivery system provides a continuous administration of the drug, ensuring a steady-state plasma concentration over 24 hours. This delivery method is advantageous as it bypasses the gastrointestinal tract, improving bioavailability and reducing side effects associated with oral administration[3].

Market Size and Growth

The global market for rotigotine transdermal patches has shown significant growth. In 2021, the total global sales for rotigotine patches were approximately $518 million, with projections to surpass $766 million by 2030, indicating a Compound Annual Growth Rate (CAGR) of 4.98% over the analysis period[4].

Key Market Players

UCB, the originator of Neupro (the branded version of rotigotine), has been a dominant player in this market. The top-selling name brand product, Neupro, independently sold over $375 million of its rotigotine TDS patches in 2021. Other companies, such as BioNxt Solutions Inc., are also entering the market with their own formulations, leveraging platform technologies to develop competitive products[1][4].

Competitive Landscape

The competitive landscape for rotigotine is evolving with the entry of generic and biosimilar products. Patent litigation cases involving Neupro have been frequent, with 63% of patent challenges decided in favor of generic patent challengers. This has led to a significant interest in generic launches, which can impact the market share of branded products[5].

Regulatory Environment

Regulatory approvals and guidelines play a critical role in the market dynamics of rotigotine. For instance, BioNxt Solutions Inc. is preparing for a human clinical pilot study in Q2 2023 to assess the relative bioavailability, skin adhesion, and skin tolerance of its new formulation compared to the name brand product. This study will be conducted in accordance with Good Clinical Practice (GCP) and the European Medical Agency (EMA) guidelines[1].

Financial Performance

The financial performance of companies involved in the rotigotine market is influenced by several factors, including sales revenue, research and development expenses, and operational costs. UCB, for example, reported revenue growth driven by the continued success of its product portfolio, including Neupro. However, the company also faces challenges such as generic erosion and higher operating expenses due to acquisitions and launch activities[2].

Market Segmentation

The rotigotine transdermal patches market is segmented based on type (1mg, 2mg, 3mg, 4mg, 6mg, 8mg) and application (treatment of Parkinson's disease and other indications). Geographically, the market is divided into regions such as North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics and growth prospects[4].

COVID-19 Impact

The COVID-19 pandemic had a significant impact on the pharmaceutical industry, including the rotigotine market. Manufacturers had to reshape their sales channels and product innovation strategies to revive from the pandemic's effects. However, the global rotigotine transdermal patches industry is expected to stabilize post-2021[4].

Future Perspectives

The future of the rotigotine market looks promising, driven by the growing therapeutic market for Parkinson’s disease, which exceeds 10 million people worldwide and is increasing. BioNxt’s scalable platform technology for TDS drug development and manufacturing also presents opportunities for additional product lines. The global transdermal skin patch market, valued at nearly $6.5 billion in 2020, is expected to reach approximately $20 billion by 2028, further indicating the potential for growth[1].

Challenges and Opportunities

Despite the advantages of rotigotine, there are challenges associated with its delivery, particularly through oral, parenteral, and pulmonary routes. Addressing these challenges could lead to more comfortable and less invasive administration methods, benefiting patients. The market also faces competition from generic products, which can impact the pricing and market share of branded formulations[3].

Key Takeaways

• Growing Market: The global rotigotine transdermal patches market is expected to grow from $518 million in 2021 to over $766 million by 2030.
• Competitive Landscape: The entry of generic and biosimilar products is changing the competitive dynamics.
• Regulatory Compliance: Adherence to GCP and EMA guidelines is crucial for new product approvals.
• Therapeutic Efficacy: Rotigotine's transdermal delivery system offers continuous drug administration, improving bioavailability.
• Future Growth: The global transdermal skin patch market and the growing therapeutic market for Parkinson’s disease present significant growth opportunities.

FAQs

What is rotigotine used for?

Rotigotine is used for the treatment of Parkinson’s disease and Restless Legs Syndrome (RLS)[3].

How does the transdermal delivery system of rotigotine work?

The transdermal delivery system of rotigotine provides a continuous administration of the drug, ensuring a steady-state plasma concentration over 24 hours[3].

What are the key market players in the rotigotine market?

Key market players include UCB, the originator of Neupro, and BioNxt Solutions Inc., which is developing its own rotigotine patch formulation[1][4].

How has the COVID-19 pandemic impacted the rotigotine market?

The COVID-19 pandemic had a significant impact on the pharmaceutical industry, but the rotigotine market is expected to stabilize post-2021[4].

What are the future growth prospects for the rotigotine market?

The market is expected to grow significantly, driven by the increasing therapeutic market for Parkinson’s disease and the expanding global transdermal skin patch market[1][4].

Sources

1. BioNxt Reports Update on Commercialization of Rotigotine Patch for Treatment of Parkinson’s Disease. BioSpace.
2. Strong first six months – UCB with continued delivery and strong resilience. UCB.
3. Current Status and Challenges in Rotigotine Delivery. PubMed.
4. Rotigotine Transdermal Patches Market Size, Share & Trends Report, 2022-2030. MarketResearch.com.
5. NEUPRO Drug Patent Profile. DrugPatentWatch.