REQUIP Drug Patent Profile

Which patents cover Requip, and what generic alternatives are available?

Requip is a drug marketed by Glaxosmithkline Llc and is included in two NDAs.

The generic ingredient in REQUIP is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Requip

A generic version of REQUIP was approved as ropinirole hydrochloride by PRINSTON INC on May 5^th, 2008.

Summary for REQUIP

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	36
Patent Applications:	2,064
Drug Prices:	Drug price information for REQUIP
What excipients (inactive ingredients) are in REQUIP?	REQUIP excipients list
DailyMed Link:	REQUIP at DailyMed

See drug prices for REQUIP

See drug sales revenues for REQUIP

Recent Clinical Trials for REQUIP

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

Sponsor	Phase
Titan Pharmaceuticals	Phase 1/Phase 2
Vanderbilt University Medical Center	Phase 4
Seoul National University Hospital	Phase 4

See all REQUIP clinical trials

Paragraph IV (Patent) Challenges for REQUIP

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REQUIP	Tablets	ropinirole hydrochloride	3 mg, 4 mg and 5 mg	020658	1	2005-02-04
REQUIP	Tablets	ropinirole hydrochloride	0.25 mg, 0.5 mg, 1 mg and 2 mg	020658	1	2004-12-22

US Patents and Regulatory Information for REQUIP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-001	Sep 19, 1997		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-005	Sep 19, 1997		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-004	Sep 19, 1997		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-004	Jun 13, 2008		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-001	Jun 13, 2008		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-002	Sep 19, 1997		DISCN	Yes	No

Expired US Patents for REQUIP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-004	Sep 19, 1997
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-007	Jan 27, 1999
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-001	Sep 19, 1997
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-004	Sep 19, 1997
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-005	Sep 19, 1997
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-006	Jan 27, 1999

International Patents for REQUIP

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

Country	Patent Number	Title	Estimated Expiration
Spain	8604143
Mexico	174643	4-AMINOALQUIL-2(3H)-INDOLONAS
Japan	S63303966	DRUG FOR TREATING PARKINSONISM
Japan	H0150703
Australia	1644588
New Zealand	224709	THE USE OF 4-(AMINOALKYL)-2-(3H)-INDOLONE DERIVATIVES IN THE TREATMENT OF PARKINSONS DISEASE

Supplementary Protection Certificates for REQUIP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0113964	SPC/GB96/039	United Kingdom		SPC/GB96/039: 20031130, EXPIRES: 20081129
0299602	C970006	Netherlands		PRODUCT NAME: ROPINIROLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAA RDBAAR ZOUT, IN HET BIJZONDER HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20761 - RVG 20765 19961202; FIRST REGISTRATION: GB PL 10592/0085 19960702
0299602	SPC/GB96/040	United Kingdom		PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
0113964	97C0037	Belgium		PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
0299602	97C0036	Belgium		PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702

Market Dynamics and Financial Trajectory for Requip (Ropinirole)

Last updated: July 30, 2025

Introduction

Requip (ropinirole) is a dopamine agonist primarily prescribed for Parkinson's disease and restless legs syndrome (RLS). Since its approval, Requip's market trajectory has been shaped by evolving clinical needs, regulatory landscapes, competitive dynamics, and emerging therapeutic alternatives. This analysis explores the current market landscape, key drivers, challenges, and future financial outlooks for Requip, offering critical insights for stakeholders aiming to understand its commercial trajectory.

Market Overview

Requip entered the global market following its approval by the U.S. Food and Drug Administration (FDA) in 1997 [1], marking a significant advancement in Parkinson’s disease management. As a non-ergoline dopamine agonist, it offers symptomatic relief by stimulating dopamine receptors, reducing motor symptoms and rigidity.

The global Parkinson's disease market is projected to grow from USD 4.4 billion in 2021 to USD 7.7 billion by 2028, registering a CAGR of approximately 8.4% [2]. Requip’s share, while significant within its niche, faces increasing competition from newer agents, including selective dopamine receptor agonists and agents with novel mechanisms of action.

In the RLS domain, Requip’s market is also robust, with a substantial patient base seeking relief from debilitating symptoms. The RLS market is expected to expand as awareness around sleep disorders increases and treatment guidelines evolve.

Key Market Drivers

1. Rising Prevalence of Parkinson’s Disease and RLS

Global demographic shifts, particularly aging populations, contribute substantially to the increasing prevalence of Parkinson’s disease, which affects over 10 million worldwide [3]. RLS affects 7-10% of adults in certain populations, further expanding the patient pool. The surge in diagnosed cases directly correlates with higher drug utilization.

2. Therapeutic Efficacy and Established Use

Requip’s longstanding approval and extensive clinical data underpin its status as an established therapy. Its efficacy in delaying disease progression and improving quality of life sustains steady demand.

3. Patent Expirations and Generic Competition

The patent for Requip expired in the U.S. in 2008, with generics flooding the market soon thereafter. Generic versions have substantially eroded Requip's market share, compressing revenues but increasing access due to lower costs.

4. Innovating Treatment Paradigms

The advent of novel therapeutics, including dopamine agonists with extended-release formulations, selective receptor targeting, and adjunctive therapies, influences Requip's market share. However, its versatility in both Parkinson's and RLS sustains its relevance.

5. Regulatory Approvals and Line Extension Opportunities

Research into new formulations (e.g., extended-release), new indications, and combination therapies may bolster Requip’s market prospects.

Market Challenges

1. Safety and Tolerability Concerns

Requip is associated with adverse effects like hypotension, somnolence, and impulse control disorders. Such safety issues have prompted cautious prescribing, especially in elderly patients.

2. Competition from Other Dopamine Agonists

Pramipexole, ropinirole's primary competitors, and newer agents like rotigotine transdermal patches offer alternative delivery methods and safety profiles, challenging Requip’s market dominance.

3. Market Penetration Limitations Post-Patent

Patent expiry led to a surge in generic use, significantly reducing Requip’s prices and revenue potential in mature markets.

4. Emergence of Non-Dopaminergic Therapies

Levodopa formulations, MAO-B inhibitors, and novel disease-modifying agents could impact demand for symptomatic treatments like Requip.

Financial Trajectory and Future Outlook

Historical Financial Performance

Initially, Requip generated substantial revenues, with peak sales approaching USD 600 million in the early 2000s [4]. Patent expiration and increased generic competition caused revenue declines, with sales dipping below USD 200 million in several markets.

Current Revenue Streams

Today, Requip's revenues stem mainly from formulary-prescribed medications in regions with limited generic penetration and formulations still protected by patents or regulatory exclusivity.

Market Prospects and Growth Opportunities

• Product Line Extensions: Development of extended-release formulations promises improved patient adherence and potentially increased sales.
• New Indications: Investigations into Requip’s utility for other neurodegenerative conditions could open additional markets.
• Geographic Expansion: Emerging markets with increasing healthcare access present growth avenues, provided regulatory and reimbursement hurdles are addressed.

Impact of Patent Litigation and Pricing Strategies

Legal battles over patent protections and strategies to maintain market exclusivity influence Requip's pricing and revenue longevity. Where patent protections diminish, aggressive marketing of generic versions further constrains margins.

Forecast

Industry projections suggest a stabilized but modest revenue pipeline for Requip, with annual sales potential in the range of USD 100-200 million in mature markets, contingent on new formulation approvals and market penetration in emerging regions.

Competitive Landscape

Requip competes chiefly with pramipexole (Mirapex), rotigotine (Neupro), and newer agents such as rotigotine patches and dopamine agonist combinations. Its entrenched position relies on familiarity, clinicians’ comfort, and approved indications. However, ongoing clinical trials and the advent of non-dopaminergic therapies may redefine the competitive landscape.

Regulatory and Market Access Considerations

The approval of biosimilars and generics has pressured Requip’s revenue streams. Payor policies emphasizing cost-effective care necessitate value-based pricing strategies. Additionally, regulatory agencies continue to scrutinize safety data, influencing prescribing patterns.

Conclusion

Requip's market trajectory exemplifies the lifecycle of a pioneering neuropharmacological agent in a highly competitive landscape. While aging populations and increased disease prevalence sustain baseline demand, patent expirations, safety considerations, and emergent therapies pose significant hurdles. Strategic investments in formulation improvements and geographic expansion could buffer revenue declines, aligning with broader market trends toward personalized, safe, and effective neurotherapeutics.

Key Takeaways

• Requip remains relevant due to its proven efficacy in Parkinson’s and RLS but faces revenue pressures from patent expirations and generics.
• Market growth is driven by aging populations and increased disease awareness but limited by safety concerns and competitive alternatives.
• Future revenue depends on successful product line extensions, regulatory approvals, and expansion into emerging markets.
• Stakeholders must monitor evolving therapeutic paradigms, regulatory environments, and pricing strategies to capitalize on new opportunities.
• The drug’s position within a competitive matrix necessitates continuous innovation and adaptation to maintain relevance.

FAQs

1. How has patent expiration affected Requip's market share?
Patent expiry in 2008 led to a surge in generic versions, drastically reducing Requip’s price and market share in mature markets, although some formulations remain protected by regulatory exclusivity.

2. What are the main safety concerns associated with Requip?
Requip’s adverse effects include hypotension, somnolence, impulse control disorders, and hallucinations, which can limit its use, especially among elderly populations.

3. Are there any recent developments or formulations that could boost Requip’s market?
Yes, extended-release formulations aim to improve adherence and reduce side effects. Ongoing research into new indications may also create additional revenue streams.

4. How does Requip's competition influence its market prospects?
Competing agents like pramipexole and rotigotine offer different delivery methods and safety profiles, leading clinicians to choose based on patient-specific factors, thus impacting Requip’s market share.

5. What emerging therapeutic trends could impact Requip's future?
Non-dopaminergic neuroprotective agents and disease-modifying therapies may shift treatment paradigms, potentially reducing reliance on symptomatic dopamine agonists like Requip.

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Sources
[1] U.S. Food and Drug Administration (FDA). Requip (ropinirole) approval details.
[2] Research and Markets. Parkinson’s Disease Treatment Market Forecast. 2022.
[3] Parkinson’s Foundation. Parkinson’s Disease Statistics.
[4] IMS Health. Pharmaceutical Sales Data, 2004-2010.