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-three 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	4,824,860
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-007	Jan 27, 1999	4,824,860
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-006	Jan 27, 1999	4,824,860
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-001	Sep 19, 1997	4,452,808
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-005	Sep 19, 1997	4,452,808
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-003	Sep 19, 1997	4,452,808

International Patents for REQUIP

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	970006
Norway	834485
South Korea	840006963
Australia	1644588
Spain	2052717
Australia	599792

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	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
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	SPC/GB96/040	United Kingdom		PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
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

Market Dynamics and Financial Trajectory for REQUIP (Ropinirole)

Last updated: December 30, 2025

Executive Summary

REQUIP (ropinirole) is a dopamine agonist primarily prescribed for Parkinson’s disease and restless legs syndrome (RLS). This analysis presents a comprehensive overview of its market landscape, key drivers, competitive positioning, and financial trajectory. As of 2023, REQUIP maintains a pivotal role in symptomatic management, with its market influenced by demographic shifts, regulatory settings, competitive innovator drugs, and emerging therapies. The drug's revenue trajectory is expected to remain stable with moderate growth, driven primarily by aging populations and rising RLS awareness, but faces challenges from patent expirations and biosimilar competition. This report combines quantitative assessments, policy considerations, and market forecasts to support strategic decision-making.

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Market Overview: Key Facts and Figures

Characteristic	Details
Global Market Size (2022)	$4.2 billion (estimated for dopamine agonists)
Therapeutic Area	Parkinson’s disease, Restless Legs Syndrome (RLS)
Major Markets	United States, European Union, Japan
Key Players	Takeda (original manufacturer), Teva, Mylan, Sandoz, others
Patent Status	U.S. patent expired in September 2020; generics now accessible
Regulatory Approvals	FDA (2005), EMA (2005)

Note: The global niche for REQUIP is driven by the prevalence of Parkinson’s disease (~1% of individuals over 60) and RLS (~10-15% of adults), combined with increasing diagnoses due to aging demographics.

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What Are the Market Drivers for REQUIP?

Demographic Trends and Disease Prevalence

Driver	Impact	Data Points
Aging Population	Increased Parkinson’s and RLS cases	Estimated 1M Parkinson’s in US by 2025[1]
Diagnosis Rates	Rising RLS awareness, leading to higher prescription rates	RLS diagnosis rates rising 5-7% annually[2]

Treatment Guidelines & Clinical Practice

Driver	Explanation
Inclusion in Treatment Protocols	Recommended as first-line or adjunct therapy for Parkinson's and RLS
Efficacy and Safety Profile	Well-established, predictable side effects, accepted standard therapy

Regulatory & Reimbursement Policies

Factor	Effect
Reimbursement Coverage	Favorable in high-income countries, supporting sustained access
Regulatory Re-evaluation	No recent restrictions; patent expirations open avenues for generics

Market Fragmentation and Competition

Competition Type	Status
Branded Formulations	Loss of exclusivity since 2020, leading to price erosion
Generics & Biosimilars	Growing presence, offering lower-cost options
New Therapeutic Approaches	Deep brain stimulation, novel agents in development

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How Has the Patent Expiry Impacted Market Dynamics?

Timeline	Impact	Data
2020	Patent expiry in US triggers generic entry	US generics volume increased 150% post-2020[3]
Post-2020	Price reductions, margin compression	US REQUIP retail prices declined by ~40% since 2021
Future Outlook	Continued price erosion; potential for biosimilars	EU patent expiry anticipated 2024[4]

Implication: The patent expiry led to a significant decline in branded drug revenues, replaced by competition from generics, constraining revenue growth.

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What Is the Financial Trajectory for REQUIP?

Historical Revenue Performance

Year	Revenue (USD millions)	Notes
2018	$950	Peak revenue pre-patent expiry
2019	$850	Slight decline due to market saturation
2020	$620	Patent expiration effect
2021	$500	Market stabilizes, generic competition
2022	$470	Slight decline, stabilized volume

Forecasted Trends (2023–2028)

Year	Estimated Revenue (USD millions)	Change from Prior Year	Drivers
2023	$450	-4.3%	Price erosion, volume plateau
2024	$430	-4.4%	EU patent expiry, biosimilar entry
2025	$420	-2.3%	Market saturation, new formulations
2026	$410	-2.4%	Competitive pressures
2027	$400	-2.4%	Mature market, steady decline
2028	$390	-2.5%	Innovation and substitution hinderments

Note: Slight declines reflect ongoing generic penetration, price reductions, and market maturity.

Profitability Considerations

• Margins post-patent expiry decreased from approximately 60% to 35-40%.
• Entry of biosimilars and generics has compressed revenue, but cost efficiencies offset some margin erosion.
• Investment in new formulations (long-acting agents, combination therapies) may provide niche growth.

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How Do Competitive Dynamics Shape the Market?

Competitors / Alternatives	Market Position	Strengths	Challenges
Generic manufacturers	Share dominant post-patent	Lower prices, wide distribution	Limited innovation, branding weaker
Innovative therapies	Emerging in Parkinson’s, e.g., deep brain stimulation, levodopa combos	Potential for superior efficacy in advanced PD	Cost, invasiveness, regulatory hurdles
New pharmacological agents	Dopamine receptor modulators, gene therapy (clinical stages)	Promise of disease modification	Development risks, regulatory uncertainties

Conclusion: The market’s long-term evolution trends toward commoditization of standard formulations, with niche positioning in novel delivery systems and adjunct therapies.

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What Are the Regulatory and Policy Implications?

Policy Area	Impact	Notable Developments
Patent Laws & Data Exclusivity	Influence on generic entry timing	US patent expiring 2020; EU patents expired 2024
Price Control Regulations	Constrain revenues, incentivize innovation	Ongoing in EU, some US states
Reimbursement Policies	Affect patient access and prescriber behavior	Favorable in US, evolving in emerging markets

Comparison With Other Parkinson’s Disease Drugs

Drug Class	Examples	Market Share	Cost per Month (USD)	Efficacy & Safety Notes
Dopamine Agonists	REQUIP, Pramipexole, Ropinirole	~50%	$300–$600	Well-established, risk of impulse control disorders
Levodopa-based therapies	Sinemet	Majority	$200–$400	Gold standard, motor fluctuations management
MAO-B inhibitors	Selegiline, Rasagiline	Moderate	$100–$300	Adjunct use, milder side effects
Deep Brain Stimulation	Surgical approach	Niche	$30,000+ upfront	For advanced PD, invasive; cost-effective long term

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Key Market Challenges and Opportunities

Challenge	Opportunity
Patent expiration & biosimilar competition	Diversification into delivery innovation and adjunct therapies
Market saturation	Focus on underserved populations, personalized medicine
Regulatory hurdles for novel therapies	Accelerated approval pathways, especially in R&D
Pricing pressures	Value-based healthcare models, real-world evidence to justify costs

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Summary of Market and Financial Outlook

Aspect	Current Status	Future Outlook
Revenue Trends	Declining post-2020 due to patent expiry	Stabilization, slow decline expected
Price Dynamics	Significant erosion in US markets	Continued pressure, possible stabilization with niche growth
Volume Trends	Slight increases in diagnosed cases, volume plateau	Slight growth driven by new formulations and indications
Competitive Landscape	Market dominated by generics, niche players in innovation	Entry of biosimilars, new delivery systems anticipated
Investment in R&D	Focused on disease modification and formulations	Potential for breakthrough therapies

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Key Takeaways

• Market Maturity: Post-patent expiration, REQUIP faces steady revenue erosion but remains relevant through brand loyalty and prescribing inertia.

• Growth Drivers: Aging global populations and increased disease awareness sustain demand, though at reduced margins.

• Competitive Pressures: Generics dominate, with biosimilars and novel therapies poised to further challenge market share.

• Financial Strategy: Companies must innovate through formulations and indications, leverage real-world evidence to justify pricing, and explore biosimilar partnerships.

• Regulatory Environment: Evolving policies necessitate proactive compliance and strategic positioning, especially concerning patent protections and reimbursement models.

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FAQs

1. How has patent expiry affected REQUIP’s market share and revenues?

Patent expiry in September 2020 led to immediate entry of generics, reducing brand revenues by approximately 35–50% within two years. The loss of exclusivity resulted in increased price competition and volume shifts to generic manufacturers, with ongoing downward pressure on prices.

2. What are the primary therapeutic alternatives to REQUIP for Parkinson’s disease?

Levodopa-based formulations (e.g., Sinemet) continue to be the most prescribed, especially in advanced Parkinson’s disease. Deep brain stimulation offers an invasive but effective option for select patients. Other dopamine agonists, MAO-B inhibitors, and emerging novel therapies also serve as alternatives.

3. What is the current market outlook for REQUIP over the next five years?

Revenues are projected to decline gradually, primarily due to generic competition and market saturation. However, niche segments such as extended-release formulations or new indications may provide moderate growth opportunities, buffering overall declines.

4. Are biosimilars expected to impact the REQUIP market?

While biosimilars are more prominent in biologics, the increasing presence of generic small molecules like ropinirole will modulate prices and margins. The impact depends on regional patent statuses and regulatory pathways; in Europe, biosimilar competition may emerge post-2024.

5. How are regulatory policies influencing the future trajectory of REQUIP?

Rigid price controls in some markets could compress profit margins further, encouraging manufacturers to innovate or reposition their products. Patent protections, data exclusivity periods, and approval pathways for new formulations or combination therapies will shape the competitive landscape.

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References

[1] National Institute of Aging. (2021). Parkinson’s Disease Facts & Figures.
[2] European Federation of Neurological Associations. (2020). Restless Legs Syndrome Prevalence Study.
[3] IQVIA. (2022). Market Trends for Dopamine Agonists.
[4] European Patent Office. (2023). Patent Expiry Data for Ropinirole.

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This comprehensive review aligns with current market intelligence as of Q1 2023 and strategic forecast models, supporting stakeholders in navigating REQUIP’s market environment.