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-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 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:	2,064
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
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-004	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
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-004	Jun 13, 2008
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-005	Oct 31, 2008
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-001	Jun 13, 2008

International Patents for REQUIP XL

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1272167
Spain	2307608
Czech Republic	303943	Vícevrstvá tableta s rízeným uvolnováním aktivní látky (Multi-layer tablet with controlled release of active substance)
Italy	1318470	MATRICI POLIMERICHE IDROFILE/LIPOFILE, IN GRADO DI CEDERE SOSTANZEFARMACOLOGIAMENTE ATTIVE A VELOCITA' PREDETERMINATA. (Multi-layer controlled-release tablet comprises an active layer and at least one barrier layer, useful for the treatment of e.g. Parkinson's disease)
South Korea	101158968
Italy	1318687	MATRICI POLIMERICHE IDROFILE/LIPOFILE, IN GRADO DI CEDERE SOSTANZEFARMACOLOGICAMENTE ATTIVE A VELOCITA' PREDETERMINATA. (Multi-layer controlled-release tablet comprises an active layer and at least one barrier layer, useful for the treatment of e.g. Parkinson's disease)

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: July 29, 2025

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Introduction

REQUIP XL (ropinirole extended-release tablets) is a long-acting formulation indicated for the treatment of Parkinson’s disease and restless legs syndrome (RLS). As a key player within the dopaminergic therapy segment, REQUIP XL’s market dynamics are influenced by a confluence of regulatory, clinical, and competitive factors. This analysis explores its global market trajectory, competitive landscape, and future growth prospects.

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Market Overview and Key Drivers

Prevalence and Demographics

The global prevalence of Parkinson’s disease (PD) surpassed 6 million in 2020 and is projected to reach 12 million by 2040, according to the Parkinson’s Foundation[1]. RLS affects approximately 7-10% of the adult population, amplifying demand for dopaminergic therapies like REQUIP XL[2]. An aging population accelerates these trends, driving increased prescription volumes.

Therapeutic Positioning

REQUIP XL is distinguished by its extended-release formulation, allowing once-daily dosing and improved patient compliance relative to immediate-release ropinirole (REQUIP). Its fixed dosing benefits consistent symptom management and minimizes dosing errors, solidifying its role in long-term PD management.

Regulatory Approvals and Labeling

Established approval for PD and RLS across major markets—including the U.S. (FDA), EU (EMA), and Japan (PMDA)—has solidified its market penetration. Clinical endorsements of REQUIP XL’s efficacy and tolerability strengthen its competitive positioning and incentivize formulary inclusion.

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Market Dynamics

Competitive Landscape

The growing approval of alternative therapies, including dopamine agonists (pramipexole, rotigotine), MAO-B inhibitors, and novel agents like safinamide, influence REQUIP XL’s market share. However, the unique extended-release profile offers a competitive advantage for patients requiring sustained symptom control.

Pricing and Reimbursement

Pricing strategies vary significantly across regions. In the U.S., REQUIP XL faces competition from generic ropinirole formulations, which have exerted downward pressure on prices. Reimbursement policies favor long-acting formulations where they demonstrate improved adherence, fostering favorable market access in certain countries.

Patents and Generic Entry

Patent protections for REQUIP XL are set to expire around mid-2020s, opening avenues for generic formulations. Generic competition often leads to significant price reductions, affecting revenue streams. Conversely, pharmaceutical companies are exploring formulation patents to prolong exclusivity, such as controlled-release patents or combination therapies.

Emerging Market Penetration

Emerging markets, characterized by rising healthcare expenditure and growing awareness, present substantial growth opportunities. The affordability of generics enhances access, yet commercial success depends on patent status and local regulatory landscapes.

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Financial Trajectory

Historical Revenue Performance

Requip XL’s global sales peaked in the early 2010s, bolstered by its innovative formulation and expanding indications. Post patent expiration threats and increasing generic competition contributed to sales plateauing and gradual decline, particularly in mature markets.

Projection and Growth Opportunities

• Post-Patent Market: As patents expire, revenue from branded REQUIP XL is expected to decline, with sales shifting toward generics. However, lifecycle management strategies—such as new combination therapies and extended indications—could mitigate this decline.

• Pipeline Developments: Pharmaceutical R&D may introduce next-generation dopamine agonists or disease-modifying agents that could impact the total market size and redefine treatment paradigms.

• Market Expansion: Entry into emerging markets with tailored pricing strategies could sustain revenue growth. Additionally, increased RLS diagnosis rates expand the patient base.

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Challenges and Risks

• Generic Competition: The imminent entry of generics is the primary risk to revenue stability, significantly impacting pricing and market share.
• Regulatory and Reimbursement Hurdles: Variability in approval processes and reimbursement policies can delay market penetration or reduce profitability.
• Clinical Adoption: Resistance from clinicians to shift from established therapies may hinder growth, especially if new drugs demonstrate superior efficacy or safety profiles.

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Future Outlook

The future financial trajectory for REQUIP XL hinges on patent protections, regional market expansion, and lifecycle management strategies. Companies may invest in new formulations, combination therapies, or novel delivery techniques to sustain market relevance. Additionally, the evolution of digital health tools might facilitate better adherence and patient monitoring, indirectly supporting pharmacotherapy sales.

In the next decade, the aging global population and increasing prevalence of movement disorders forecast a steady demand for dopaminergic therapies. While branded sales are likely to decline amid growing generic competition, strategic diversification and regional expansion can support a resilient revenue profile.

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Key Takeaways

• The rising prevalence of Parkinson’s disease and RLS underpins long-term demand for dopaminergic therapies such as REQUIP XL.
• Patent expiry and subsequent generic entry pose significant revenue challenges; lifecycle management is crucial for sustained profitability.
• Market expansion into emerging economies offers growth potential, contingent on pricing and regulatory strategies.
• Development of advanced formulations or combination therapies may mitigate the impact of generics and extend market presence.
• Navigating reimbursement landscapes remains essential; regions with favorable policies may serve as growth anchors.

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FAQs

1. When is REQUIP XL’s patent expected to expire, and how will this impact sales?
Patent protections for REQUIP XL are projected to expire around mid-2020s, opening up the market to generic competitors. This typically results in substantial price erosion and revenue decline for branded formulations; however, lifecycle strategies may offset this impact.

2. How does REQUIP XL compare to other dopamine agonists in treatment efficacy?
REQUIP XL provides sustained symptom control with once-daily dosing and has demonstrated comparable efficacy to immediate-release formulations. Its extended-release formulation enhances adherence, particularly in long-term management.

3. What are the key growth opportunities for REQUIP XL beyond mature markets?
Expanding into emerging markets with tailored pricing, increasing diagnosis rates of RLS and PD, and developing new formulations or combination therapies represent significant growth avenues.

4. How do reimbursement policies influence REQUIP XL’s market penetration?
Reimbursement policies that favor long-acting formulations and have favorable formulary coverage can enhance access and sales. Conversely, lack of reimbursement or stringent approval criteria hinder market penetration.

5. What role does digital health technology play in the future of REQUIP XL’s market trajectory?
Digital health tools can improve medication adherence, monitor symptom progression, and facilitate remote patient management, indirectly supporting continued use and adherence to REQUIP XL.

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References

1. Parkinson’s Foundation. “Parkinson’s Disease Stats.” 2022.
2. National Institute of Neurological Disorders and Stroke. “Restless Legs Syndrome Information Page.” 2021.