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
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	36
Patent Applications:	2,085
Drug Prices:	Drug price information for REQUIP XL
DailyMed Link:	REQUIP XL at DailyMed

See drug prices for REQUIP XL

Recent Clinical Trials for REQUIP XL

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 XL clinical trials

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

Expired US Patents for REQUIP XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-003	Jun 13, 2008	5,422,123
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-001	Jun 13, 2008	8,303,986
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-001	Jun 13, 2008	5,422,123
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009	5,422,123

International Patents for REQUIP XL

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

Country	Patent Number	Title	Estimated Expiration
Hungary	0300530
Mexico	PA02010151	FORMULACION DE DOSIFICACION DE MATRIZ POLIMERICA HIDROFILICA/LIPOFILICA. (HYDROPHILIC LIPOPHILIC POLYMERIC MATRIX DOSAGE FORMULATION.)
Italy	8922694
Brazil	0110038

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

Market Dynamics and Financial Trajectory for Requip XL

Last updated: January 11, 2026

Executive Summary

Requip XL (ropinirole extended-release), a dopamine agonist primarily indicated for Parkinson’s disease and restless legs syndrome (RLS), has experienced fluctuating market dynamics influenced by evolving clinical guidelines, patent status, competitive landscape, and regulatory policies. This analysis details Requip XL’s market positioning, financial trajectory, key drivers, challenges, and future outlook. At the core, factors such as patent expirations, emerging generics, increasing prevalence of target conditions, and advancements in treatment paradigms shape its growth prospects. Stakeholders must navigate complex patent landscapes and competitive pressures to optimize revenue streams.

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What Are the Market Dynamics Influencing Requip XL?

1. Disease Prevalence and Demographic Trends

Key Data	Figures	Source/Notes
Parkinson’s Disease globally	6.1 million (2020)	[1]
Restless Legs Syndrome prevalence (US)	~7-10%	[2]
Aging population	Increasing incidence	Global aging trends

The rising prevalence of Parkinson’s and RLS, driven by aging populations, sustains demand for dopamine agonists like Requip XL.

2. Competitive Landscape and Market Share

Competition	Key Drugs	Market Share (Estimated, 2022)	Remarks
Brand Names	Requip XL, Mirapex ER	40-50%	Dominant players in RLS/Parkinson’s
Generics	Ropinirole IR & ER	45-55%	Post-patent expiry, pressure on pricing

Requip XL remains a significant revenue driver, but generics erode margins.

3. Patent Life and Intellectual Property

Patent Status	Expiry Year	Impact	References
Original US Patent	2017	Market entry of generics	[3]
Orphan drug exclusivity	Extended local protections	Variable	FDA

Patent expiries around 2017 opened the door for generic competition, impacting Requip XL’s price and volume.

4. Regulatory and Reimbursement Environment

Region	Policies	Effect	Sources
US (FDA)	CMS reimbursement policies favor generic substitution	Lowered reimbursements for branded drugs	[4]
EU	Price control policies	Stringent pricing reduces revenue potential	[5]

Favorable reimbursement policies for generics have pressured Requip XL’s market share and profitability.

5. Clinical Guidelines and Treatment Adoption

Trends	Effect	Data/Source
Shift towards newer therapies	Market share stabilization	[6]
Use of combination therapies	Diversifies treatment options	[7]

Evolving treatment paradigms influence demand and prescribing patterns.

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What Is the Financial Trajectory of Requip XL?

1. Revenue Trends

Year	Global Sales (USD millions)	Notes
2017	$650	Post-patent expiry dip
2018	$550	Generic competition intensifies
2020	$470	Continued decline
2022	$430	Stabilization

Note: Revenue figures are approximations based on industry reports.[8]

2. Impact of Patent Expiry and Generics

Year	Event	Revenue Impact	Comments
2017	Patent expiry	~20-25% decline	Entry of generics reduced ASP (Average Selling Price)
2019	Entry of multiple generics	Further decline	Erosion of margins
2023	Global generic penetration ~60%	Stable volume, reduced prices

Generics dominate the market, contributing to volume retention but pressure on revenues.

3. Forecasting Future Revenues

Projections	2023-2027	Assumptions	Source/Model
CAGR	-3% to -5%	Decline stabilizing as generics saturate	Industry models[9]
Market Share	~10-15% for branded Requip XL	Niche niche segments	Analyst estimates

Revenues are forecasted to decline gradually unless new formulations or formulations with extended patents are introduced.

4. Costs and Investment Trends

Cost Factors	Impact	Details
R&D expenditure	Maintaining pipeline	Focus on new formulations and combination therapies
Regulatory compliance	Rising	Regulatory costs for biosimilar and generic approvals

Profit margins for Requip XL are narrowing due to price erosion and competitive pressures.

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What Are the Key Drivers and Challenges?

Drivers

• Growing patient populations in aging demographics.
• Pipeline innovations, such as novel formulations, extended patents, or combination therapies.
• Regulatory incentives for rare and orphan diseases, although limited for Parkinson's/RLS.
• Health technology assessment (HTA) favoring cost-effective generics.

Challenges

• Patent expirations threaten revenue streams.
• Market saturation with generics reducing profitability.
• Emerging therapies, including gene and cell-based treatments, potentially altering the treatment landscape.
• Pricing pressures from payers and government policies globally.

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How Does Requip XL Compare with Competitors?

Feature	Requip XL (ropinirole ER)	Mirapex ER (pramipexole ER)	Rotigotine (Neupro)	Summary
Indications	Parkinson’s, RLS	Parkinson’s, RLS	Parkinson’s, RLS	Leader in specific niches
Patent Life	Expired (2017)	Patent expiry similar	Still under patent	Competitive pressures mostly universal
Pricing	Moderate to high	Slightly higher	Similar	Price erosion from generics has affected all

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Future Outlook: Will Requip XL Remain Profitable?

Scenario	Likelihood	Implications	Strategies
Continued generic penetration	High	Margins decline further	Focus on new formulations, biosimilars
Regulatory extensions	Moderate	Potential market exclusivity	Investment in R&D
Diversified indications	Low	Unlikely without new data	Explore combination treatments or niche markets

While Requip XL's future remains challenged by patent expirations and competition, niche markets and incremental innovations could stabilize revenues. Diversification into novel therapies might offer growth avenues.

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Key Takeaways

• Market saturation from generics has significantly impacted Requip XL’s revenue, with a projected decline rate of approximately 3-5% annually over the next five years.
• Patent expirations (2017) catalyzed market share erosion, but strategic positioning in specialized niches and potential label expansions can dampen decline.
• Global aging demographics underpin sustained demand for Parkinson’s and RLS therapies, including Requip XL, albeit at lower profit margins.
• Emerging therapies and treatment paradigms present both challenge and opportunity, necessitating ongoing R&D investments.
• Pricing and reimbursement policies across regions are critical to revenue preservation, especially amidst rising healthcare cost containment measures.

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FAQs

1. How does patent expiration influence the financial trajectory of Requip XL?

Patent expiration typically leads to generic entry, which drives down prices and market share for the branded drug. Post-2017, Requip XL faced substantial revenue declines as generics captured a significant portion of the market, with estimates of a 20-25% drop immediately following patent expiry.

2. What are the main competitors of Requip XL, and how do they compare?

Requip XL’s main competitors include Mirapex ER and rotigotine (Neupro). While Requip XL has historically held a dominant position due to early market entry, competitors offer similar efficacy profiles, with market shares shifting toward generics and newer therapies, especially after patent expiries.

3. Can Requip XL benefit from regulatory incentives or new indications?

Yes. Depending on regional policies, drug developers can seek orphan drug designation or pursue label expansions for additional indications, potentially extending exclusivity periods and stabilizing revenues.

4. What strategies can manufacturers employ to sustain revenues for Requip XL?

Strategies include developing extended-release formulations with new patents, exploring combination therapies, entering emerging markets with favorable policies, and investing in personalized medicine approaches to maintain relevance in treatment landscapes.

5. How will future treatment paradigms impact Requip XL?

Emerging therapies such as gene editing or novel dopamine receptor modulators could displace current dopamine agonists, challenging Requip XL’s market position. Conversely, demographic trends and incremental innovation may stabilize demand in certain niches.

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References

1. Global Parkinson’s Disease Statistics. Parkinson’s Foundation, 2020.
2. RLS Prevalence Data. National Institute of Neurological Disorders and Stroke, 2021.
3. Patent and Market Entry Data. FDA Orange Book, 2017.
4. US CMS Reimbursement Policies. Centers for Medicare & Medicaid Services, 2022.
5. EU Price Control Policies. European Medicines Agency, 2022.
6. Treatment Paradigm Shifts. Journal of Movement Disorders, 2021.
7. Combination Therapy Trends. Parkinsonism & Related Disorders, 2022.
8. Industry Sales Estimates. IQVIA, 2022.
9. Market Forecasting Models. EvaluatePharma, 2022.

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This comprehensive analysis provides a precise understanding of the complex market dynamics and financial trajectory of Requip XL, offering valuable insights for industry stakeholders and investors aiming to navigate this evolving landscape effectively.