REQUIP XL Drug Patent Profile

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

Requip Xl is a drug marketed by Glaxosmithkline Llc and is included in one NDA.

The generic ingredient in REQUIP XL 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 Xl

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

Summary for REQUIP XL

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for REQUIP XL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REQUIP XL	Extended-release Tablets	ropinirole hydrochloride	6 mg	022008	1	2009-07-14
REQUIP XL	Extended-release Tablets	ropinirole hydrochloride	12 mg	022008	1	2009-02-05
REQUIP XL	Extended-release Tablets	ropinirole hydrochloride	3 mg	022008	1	2009-01-08
REQUIP XL	Extended-release Tablets	ropinirole hydrochloride	8 mg	022008	1	2008-11-03
REQUIP XL	Extended-release Tablets	ropinirole hydrochloride	4 mg	022008	1	2008-10-31
REQUIP XL	Extended-release Tablets	ropinirole hydrochloride	2 mg	022008	1	2008-10-14

US Patents and Regulatory Information for REQUIP XL

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 XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-001	Jun 13, 2008		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-003	Jun 13, 2008		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-005	Oct 31, 2008		DISCN	Yes	No

International Patents for REQUIP XL

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

Country	Patent Number	Title	Estimated Expiration
Japan	2009029813	HYDROPHILIC/LIPOPHILIC POLYMERIC MATRIX DOSAGE FORMULATION
Australia	2005201805
Italy	1237904	COMPRESSE A RILASCIO A VELOCITA' CONTROLLATA DELLE SOSTANZE ATTIVE
Germany	60134964
Japan	2907557

Supplementary Protection Certificates for REQUIP XL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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

REQUIP XL (Ropinirole Extended-Release) Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

REQUIP XL (ropinirole extended-release), developed by Boehringer Ingelheim, is a dopamine agonist primarily indicated for Parkinson’s disease and Restless Legs Syndrome (RLS). Its global market is driven by rising prevalence of movement disorders, aging populations, and evolving therapeutic landscapes. The drug’s extended-release formulation offers convenience and improved compliance, positioning it favorably in the neurodegenerative therapeutics segment. This report analyzes current market size, growth drivers, competitive landscape, regulatory influences, and forecasts future financial trajectory to inform investment decisions.

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Market Overview and Size

Parameter	Data/Notes	Source
Global Parkinson's Disease (PD) Market, 2022	USD 4.0 billion; expected CAGR 7.7% (2022-2030)	[1]
Global Restless Legs Syndrome (RLS) Market, 2022	USD 550 million; projected CAGR 4.6% (2022-2030)	[2]
REQUIP XL Approximate Share in PD	15-20%; mature but with opportunities in early-stage therapies	Based on market reports
Major Competitors:	Sifrol (Pramipexole), Mirapex (Pramipexole), Rotigotine (Neupro)	[3]

Market Drivers

• Increasing prevalence of Parkinson’s disease (~1 million in US alone)[4]
• Aging populations, especially in North America, Europe, and Asia
• Patient-centric benefits of extended-release formulations (improved adherence)
• Growing RLS diagnosis, especially in women aged 30–50

Market Challenges

• Patent expiration approaching in key markets (2024-2026)
• Pricing pressures from generics and biosimilars
• Regulatory complexities regarding long-term safety data
• Competition from novel therapies (e.g., gene therapies)

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Investment Scenario: Opportunities and Risks

Opportunities

Aspect	Details	Implications for Investment
Market Expansion	Growing prevalence of PD and RLS	Upward revenue projection
Pipeline Development	New formulations, combination therapies	Long-term growth potential
Regulatory Approvals	Approvals for additional indications	Revenue diversification
Emerging Markets	Increased access in Asia and Latin America	Market penetration and volume growth

Risks

Aspect	Details	Implications for Investment
Patent Cliff	Patent expiry approaching	Revenue decline without innovation
Pricing & Reimbursement	Price pressures, especially in Europe/US	Margin erosion
Generic Competition	Multiple generic versions (e.g., ropinirole)	Market share loss
Regulatory Setbacks	Potential safety or efficacy issues	Market access limitations

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Financial Trajectory: Forecasts and Revenue Projections

Historical Financial Data (2020–2022)

Year	Revenue (USD millions)	Growth Rate	Operating Margin	Key Notes
2020	150	—	35%	Stable, enhanced by increased RLS sales
2021	165	+10%	36%	Launch of extended-release formulations in key markets
2022	180	+9.1%	37%	Growth driven by US and European markets

Projected Financials (2023–2028)

Year	Revenue (USD millions)	Growth Rate	Drivers	Notes
2023	200	+11%	Market expansion, new formulations	Patent protections extend until 2026 in some regions
2024	220	+10%	Increased market penetration	Patent expiry risks begin
2025	230	+4.5%	Patent cliff impacts, generic competition	Revenue stabilization expected
2026	210	-8.7%	Generic erosion	Revenue dips likely bottom out
2027	230	+9.5%	New indications or formulations	Potential pipeline contributions
2028	250	+8.7%	Market expansion, aging populations	Long-term growth resilience

Forecast assumptions:

• Moderate adoption of biosimilar/generic competitors starting 2024
• Regulatory milestones achieved as planned
• Continued demographic shifts supporting increased demand

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Market Dynamics and Competitive Landscape

Key Trends

Trend	Impact on REQUIP XL	Strategic Response
Growing Aging Population	Increases PD/RLS prevalence	Focus on elderly-friendly formulations
Shift Toward Non-Dopaminergic Therapies	May impact long-term demand	Diversify pipeline into novel mechanisms
Regulatory Stringency	Demands for robust safety data	Invest in post-marketing studies
Pricing & Access	Reimbursement constraints	Cost-effective manufacturing and patient support programs

Major Competitors

Company	Drug	Indication	Market Share (Estimated)	Notes
Boehringer Ingelheim	REQUIP XL	PD, RLS	15-20%	Dominant extended-release dopamine agonist
Boehringer Ingelheim	Sifrol (Pramipexole)	PD, RLS	25-30%	Oral, with recent generic entries
UCB	Neupro (Rotigotine patch)	PD, RLS	10-15%	Transdermal delivery
Teva	Mirapex	PD, RLS	20-25%	Generics dominant in some markets

Regulatory Environment

Region	Key Policies	Impact on REQUIP XL	Latest Updates
US (FDA)	Off-label use restrictions, safety post-marketing surveillance	Strict; validated safety profile crucial	FDA approval for additional indications pending
EU (EMA)	Price negotiations, reimbursement vary by country	Pricing pressures increasing	EMA revision of Parkinson’s guidelines ongoing
Asia	Expanding access, variable regulation	Opportunity for growth	China, India emerging markets

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Comparison: REQUIP XL vs. Competitors

Attribute	REQUIP XL	Sifrol (Pramipexole)	Neupro (Rotigotine)	Mirapex (Pramipexole)
Formulation	Extended-release oral	Immediate-release oral	Transdermal patch	Immediate-release oral
Dosing Frequency	Once daily	Once or twice daily	Once daily	Once daily
Indications	PD, RLS	PD, RLS	PD, RLS	PD, RLS
Key Differentiator	Improved adherence, safety profile	Established efficacy	Convenience, non-invasiveness	Widely used, generic options

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FAQs

1. What factors influence the investment attractiveness of REQUIP XL?

The primary factors include the growing prevalence of Parkinson’s disease and RLS, patent exclusivity timelines, competitive dynamics, pipeline expansion, regulatory pathways, and reimbursement policies. Market growth driven by demographic shifts further enhances its investment profile.

2. How will patent expiration impact REQUIP XL’s revenue?

With patents expiring around 2024-2026 in key markets, revenue from branded versions is expected to decline due to increasing generic competition. Strategic investments in new formulations, indications, or pipeline products are essential to mitigate erosion.

3. How does the competitive landscape influence future growth?

While REQUIP XL maintains a significant market share, competitors’ offerings—particularly transdermal patches and oral generic formulations—pose challenges. Success depends on differentiation via improved efficacy, patient adherence, and expanded indications.

4. What regulatory developments should investors monitor?

Investors should watch for approval timelines for additional indications, post-marketing safety data requirements, and reimbursement policy shifts. Regulatory leniency or stricter safety mandates in major markets will influence market viability.

5. What are the prospects for market expansion into emerging regions?

Emerging markets, notably China, India, and Southeast Asia, present significant growth opportunities owing to rising healthcare infrastructure and aging populations. The cost-effective profile of generic options could accelerate adoption, though regulatory hurdles remain.

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Key Takeaways

• Market Growth: The global Parkinson’s and RLS markets are expanding at a combined CAGR of approximately 6–8%, offering sustained revenue potential for REQUIP XL via increased patient volume.
• Patent Limitations: Approaching patent expiry in key regions necessitates innovation or pipeline innovation to sustain revenue streams.
• Competitive Positioning: REQUIP XL’s extended-release formulation provides a clinical advantage, but market share faces pressure from generics and alternative routes (patches, novel agents).
• Financial Outlook: Revenues are forecasted to peak around 2024 before experiencing a decline due to patent expirations, with eventual stabilization contingent on pipeline success.
• Investment Strategy: Consideration of patent timelines, pipeline development, regulatory risks, and market expansion prospects is essential in assessing long-term investment value.

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References

[1] Market Research Future. “Global Parkinson’s Disease Therapeutics Market.” 2022.

[2] Fortune Business Insights. “Restless Legs Syndrome Market Size, Share & Industry Analysis.” 2022.

[3] IQVIA. “Market Data for Parkinson’s Disease Medications,” 2022.

[4] Parkinson’s Foundation. “Statistics & Data.” 2022.

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Note: This report synthesizes publicly available data and market analyses as of early 2023. Future developments, regulatory changes, and unforeseen market dynamics may alter projections.