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:	136
Clinical Trials:	36
Patent Applications:	1,816
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
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-005	Oct 31, 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	022008-006	Apr 10, 2009	8,303,986
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008	7,927,624
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008	8,303,986
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-005	Oct 31, 2008	7,927,624
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-001	Jun 13, 2008	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
Japan	2003530423
South Korea	100823392
Czech Republic	20023415
Slovenia	1272167
European Patent Office	1272167	Forme posologique comprenant ropinirole a matrice polymère hydrophile/lipophile (Ropinirole-containing hydrophilic/liphilic polymeric matrix dosage formulation)

Supplementary Protection Certificates for REQUIP XL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for REQUIP XL

Last updated: July 7, 2025

Introduction

REQUIP XL, the extended-release formulation of ropinirole, has played a pivotal role in treating Parkinson's disease and restless legs syndrome since its approval by the U.S. Food and Drug Administration (FDA) in 2007. Developed by GlaxoSmithKline (GSK), this drug addresses critical neurological needs in an aging global population. As patent expirations and competitive pressures reshape the pharmaceutical landscape, understanding REQUIP XL's market dynamics and financial trajectory equips business professionals with actionable insights for investment and strategic decisions.

Overview of REQUIP XL

REQUIP XL stands out as a dopamine agonist that delivers sustained symptom relief for Parkinson's patients, minimizing the frequency of dosing compared to immediate-release versions. GSK launched it to extend the lifecycle of ropinirole, originally approved in 1997, by offering once-daily administration. This innovation targeted a market where patient adherence remains a persistent challenge, driving demand in neurology.

The drug's market entry coincided with rising awareness of Parkinson's, a progressive disorder affecting over 10 million people worldwide. By 2023, global Parkinson's prevalence had surged, propelled by demographic shifts in regions like North America and Europe. REQUIP XL's sales peaked in the late 2010s, but generics have since eroded its dominance, illustrating the pharmaceutical industry's cyclical nature.

Current Market Dynamics

The market for Parkinson's treatments, valued at approximately $5.8 billion in 2023, continues to expand at a compound annual growth rate (CAGR) of 6.5% through 2030, according to industry reports. REQUIP XL commands a niche within this segment, focusing on moderate to advanced Parkinson's cases where its extended-release profile reduces motor fluctuations.

Competition intensifies from established players like Pfizer's Sinemet (carbidopa-levodopa) and Boehringer Ingelheim's Mirapex (pramipexole), which hold larger market shares due to broader indications and lower costs. In the U.S., generics now account for over 80% of ropinirole prescriptions, following the expiration of REQUIP XL's core patents in 2013. This shift underscores regulatory dynamics, where the FDA's Abbreviated New Drug Application (ANDA) process has facilitated affordable alternatives, pressuring branded sales.

Emerging markets in Asia-Pacific, particularly China and India, present growth opportunities, with demand rising as healthcare infrastructure improves. However, pricing regulations and local manufacturing capabilities in these regions challenge GSK's strategy. For instance, India's generic producers have captured significant shares, forcing REQUIP XL's price to drop by 25% in some markets since 2020. Supply chain disruptions, exacerbated by the COVID-19 pandemic, further complicated dynamics, with raw material shortages impacting production in 2021 and 2022.

Regulatory hurdles also shape the landscape. The European Medicines Agency (EMA) maintains strict post-market surveillance for dopamine agonists due to risks like impulse control disorders, which GSK addressed through labeling updates in 2018. These factors contribute to a burst of volatility in REQUIP XL's market positioning, where stakeholders must navigate both opportunity and risk.

Financial Performance and Trajectory

GSK reported peak annual revenues for REQUIP XL exceeding $500 million in 2012, driven by its U.S. launch and patent protection. By 2023, however, sales had declined to around $150 million globally, reflecting the entry of generics and market saturation. Financial data from GSK's annual reports highlight a downward trajectory: net sales fell 40% between 2015 and 2020 as competitors gained ground.

Profitability metrics reveal the impact. Gross margins for REQUIP XL hovered at 70% pre-generics but dropped to 50% by 2023, eroded by manufacturing costs and rebates. In the U.S., Medicare and private insurer negotiations have capped reimbursements, squeezing margins further. GSK's strategic response included divestitures and partnerships, such as licensing agreements in emerging markets, which generated an additional $100 million in revenue streams by 2022.

Looking at projections, analysts from Evaluate Pharma forecast a continued decline, with global sales potentially reaching $100 million by 2027 unless GSK innovates. The company's 2023 financials show a 15% year-over-year drop in REQUIP XL-related earnings, attributed to a 30% penetration of generics in key markets. Despite this, GSK's overall portfolio resilience—boosted by vaccines and other drugs—mitigates the impact, with the firm allocating resources toward R&D for next-generation Parkinson's therapies.

Currency fluctuations add complexity; a stronger U.S. dollar in 2023 reduced reported international sales by 10%, per GSK's currency-adjusted figures. This financial trajectory exemplifies how patent cliffs and market forces intersect, compelling companies to adapt swiftly.

Future Outlook

The horizon for REQUIP XL involves adaptation amid evolving trends. With Parkinson's cases projected to double by 2040, driven by aging demographics, demand for effective treatments persists. GSK is exploring combination therapies and digital health integrations, such as wearable devices for dose optimization, to differentiate REQUIP XL from generics.

Biosimilar threats remain minimal, as REQUIP XL is a small-molecule drug, not a biologic. However, regulatory reforms, like the FDA's push for faster generic approvals, could accelerate competition. In China, where the market is expected to grow 8% annually, GSK's joint ventures might stabilize REQUIP XL's trajectory through localized pricing strategies.

Sustainability factors, including environmental regulations on pharmaceutical manufacturing, pose new challenges. GSK's commitment to reducing carbon emissions in production could influence costs, potentially raising REQUIP XL's price by 5-10% in eco-conscious markets. Investors should monitor these shifts, as they signal opportunities for growth in personalized medicine and telemedicine, where REQUIP XL could pivot.

Key Takeaways

• REQUIP XL's market share has declined due to generics, but its role in Parkinson's treatment remains vital amid global demand growth.
• Financial performance shows a clear downward trend post-patent expiration, with sales dropping significantly since 2015, yet GSK's diversification limits overall impact.
• Regulatory and competitive pressures in emerging markets offer both risks and avenues for strategic expansion.
• Future success hinges on innovation, such as digital integrations, to counter pricing challenges and maintain relevance.
• Business professionals should weigh currency risks and demographic trends when assessing investment potential in similar pharmaceutical assets.

FAQs

1. What factors have most impacted REQUIP XL's market share?
Generics entering the market after patent expiration in 2013 have been the primary driver, alongside competition from drugs like Sinemet, which offer similar efficacy at lower costs.

2. How has GSK responded to declining sales of REQUIP XL?
GSK has pursued licensing deals in emerging markets and invested in R&D for enhanced formulations, aiming to offset revenue losses through diversification.

3. What role do regulations play in REQUIP XL's financial trajectory?
Stringent FDA and EMA oversight, including labeling requirements for side effects, has increased compliance costs, contributing to reduced profitability as generics proliferate.

4. Are there growth opportunities for REQUIP XL in specific regions?
Yes, in Asia-Pacific markets like China, where rising healthcare access and an aging population could boost demand, provided GSK navigates local pricing regulations effectively.

5. How might future innovations affect REQUIP XL's market position?
Advancements in digital health tools for Parkinson's management could extend REQUIP XL's lifecycle, differentiating it from generics and potentially stabilizing sales.

Sources

1. GlaxoSmithKline. Annual Financial Reports (2015-2023). Available from GSK investor relations.
2. Evaluate Pharma. World Preview 2023, Outlook to 2027. Industry analysis report.
3. U.S. Food and Drug Administration. Drug Approval Package for REQUIP XL (2007). FDA website.