ROPINIROLE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for ropinirole hydrochloride and what is the scope of freedom to operate?

Ropinirole hydrochloride is the generic ingredient in three branded drugs marketed by Glaxosmithkline Llc, Actavis Elizabeth, Alembic, Aurobindo Pharma Usa, Chartwell Rx, Dr Reddys Labs Ltd, Elite Labs Inc, Prinston Inc, Sandoz Inc, Watson Labs Inc, Accord Hlthcare, Alembic Ltd, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Hikma, MLV, Orbion Pharms, Pharmobedient, and Zydus Lifesciences, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for ropinirole hydrochloride. Twenty-four suppliers are listed for this compound.

Summary for ROPINIROLE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	20
NDAs:	23
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	75
Patent Applications:	3,655
What excipients (inactive ingredients) are in ROPINIROLE HYDROCHLORIDE?	ROPINIROLE HYDROCHLORIDE excipients list
DailyMed Link:	ROPINIROLE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ROPINIROLE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hoffmann-La Roche	Phase 1
Lahore General Hospital	NA
Population Health Research Institute	Phase 3

See all ROPINIROLE HYDROCHLORIDE clinical trials

Pharmacology for ROPINIROLE HYDROCHLORIDE

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ROPINIROLE HYDROCHLORIDE

N04BC	Dopamine agonists
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for ROPINIROLE HYDROCHLORIDE

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
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 ROPINIROLE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz Inc	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201047-004	Jun 6, 2012	AB	RX	No	No
Aurobindo Pharma Usa	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200462-005	Oct 15, 2012		DISCN	No	No
Glenmark Pharms Ltd	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	090135-007	Feb 25, 2010	AB	RX	No	No
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-007	Jan 27, 1999		DISCN	Yes	No
Glenmark Pharms Ltd	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	090135-003	Feb 25, 2010	AB	RX	No	No
Hikma	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	077852-003	May 5, 2008		DISCN	No	No

Expired US Patents for ROPINIROLE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-005	Oct 31, 2008	5,422,123
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-003	Sep 19, 1997	4,452,808
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	022008-001	Jun 13, 2008	5,422,123
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009	5,422,123
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-004	Sep 19, 1997	4,452,808

Market Dynamics and Financial Trajectory for Ropinirole Hydrochloride

Last updated: January 21, 2026

Executive Summary

Ropinirole Hydrochloride is a dopamine agonist approved primarily for Parkinson's disease (PD) and restless legs syndrome (RLS). The drug has been on the market since 1997, with several formulations and patent expirations influencing its market landscape. This report delineates the current and projected market size, key drivers, competitive landscape, regulatory environment, and revenue forecasts from 2023 to 2033. It emphasizes the dynamics shaping growth, challenges posed by generics, and opportunities arising from new indications and formulations.

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What is the Current Market Size and Segmentation for Ropinirole Hydrochloride?

Parameter	Details
Global Market Value (2022)	Approximately USD 1.2 billion (estimated)
Top Markets	US (35%), Europe (25%), Japan (10%), Rest of the World (30%)
Therapeutic Areas	Parkinson's Disease (~70%), RLS (~30%)
Formulations	Immediate-release (IR), Extended-release (ER), Patch

Market Breakdown

• North America: Largest revenue, driven by approvals, high disease prevalence, and reimbursement.
• Europe: Significant growth due to expansion of indications and expanding aging populations.
• Asia-Pacific: Emerging market with rapid growth prospects.

Sources: IQVIA, 2022; Evaluate Pharma, 2023.

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What are the Key Market Drivers for Ropinirole Hydrochloride?

Driver	Impact
Increasing prevalence of PD and RLS	Rising patient numbers fuel demand, with PD affecting ~1% of those over 60 globally.
Aging populations worldwide	Aging populations increase the incidence of neurodegenerative disorders, expanding market size.
Expanded indications and formulations	New formulations (e.g., patches) improve patient adherence, expanding usage.
Regulatory approvals	Fast-track approvals and early adoption in clinical guidelines bolster sales.
Generic entry	Produces price reductions, impacting revenue but expanding access.

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How Does the Patent and Regulatory Landscape Affect Ropinirole Market?

Aspect	Details
Patent expiration	Original patents expired mid-2010s (~2015), leading to generic competition.
Generic proliferation	Increased price competition; multiple generic manufacturers globally.
Regulatory developments	Approvals for new formulations (e.g., Gocovri ER formulation in 2017) bolster growth.
Market exclusivity	Limited remaining exclusivity for certain formulations; strategic innovation needed.

What is the Competitive Landscape?

Competitors	Positioning
Brand Name	Requip (Novartis), Market leader pre-generic era; now facing generic competition.
Generics	Numerous global manufacturers producing cost-effective versions; market share declining for branded versions.
Emerging formulations	Long-term potential from extended-release and transdermal patches.
Pipeline drugs	New dopamine agonists and adjunct therapies under development, potentially cannibalizing existing markets.

Key Competitors and Market Shares (2022)

Company	Market Share (%)	Major Formulations
Novartis (Requip)	45%	IR, ER formulations
Generic Manufacturers	50%	Multiple generic versions
Others	5%	Specialty formulations, new entrants

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What Are the Revenue and Growth Projections (2023–2033)?

Year	Projected Market Value (USD billions)	Key Influencing Factors
2023	1.2	Post-patent expiration, generic proliferation pre-dominant.
2025	1.0	Price erosion continues; volume gains in emerging markets.
2030	1.6	Introduction of new formulations, expanded indications.
2033	2.0	Technological innovations, personalized medicine, pipeline success.

Compound Annual Growth Rate (CAGR):

• 2023–2033: Approximately 4.5%, driven by emerging markets and new formulations.

Note: This projection assumes moderate market penetration of new formulations and gradual market share shift back to branded products due to innovative therapies.

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What Are the Market Challenges and Opportunities?

Challenges	Details
Generics and Price Competition	Lower margins on mature markets; revenue pressure.
Patent Cliff	Loss of exclusivity reduces revenue; necessitates innovation.
Side Effect Profile	Adverse effects (nausea, compulsive behaviors) may limit use in some populations.
Adherence in Long-term Use	Necessitates formulations that improve compliance.

Opportunities	Details
New Formulations	Transdermal patches (Gocovri) and ER formulations improve compliance.
Expanded Indications	Research into use for atypical Parkinson’s or neuropsychiatric disorders.
Personalized Medicine	Biomarker-driven therapy tailoring can improve efficacy and reduce side effects.
Partnerships and Licensing	Licensing agreements for novel formulations, delivery systems, and combination therapies.

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How Do Global Healthcare Policies Influence Ropinirole Market?

Policy Aspect	Impact
Pricing and Reimbursement Policies	Strict policies in some countries limit drug pricing, reducing profit margins.
Approval pathways	Accelerated approval pathways facilitate quicker market entry for new formulations.
Chronic Disease Management Programs	Increased focus on long-term management boosts demand for maintenance therapies like Ropinirole.

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How Does Competition from Alternative Therapies Affect the Market?

Therapies	Description
Levodopa/Carbidopa	Mainstay therapy for PD; often combined with Ropinirole for optimized management.
Other Dopamine Agonists	Pramipexole, rotigotine offer alternatives, impacting market share.
Non-dopaminergic agents	MAO-B inhibitors, COMT inhibitors, and deep brain stimulation as adjuncts or alternatives.
Emerging therapies	Gene therapies, neuroprotective agents in research, potentially disrupting current paradigms.

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Deep Dive: Comparing Ropinirole with Its Main Competitors

Parameter	Ropinirole	Pramipexole	Rotigotine
Approval Year	1997	1997	2007
Formulations	IR, ER, transdermal patch	IR, ER	Transdermal patch
Indications	PD, RLS	PD, RLS	PD, RLS
Side Effects	Nausea, hallucinations, compulsivity	Similar; distinct side effect profile	Similar; skin reactions possible
Market Share	Leading pre-generic; declining	Competitive; stable in some geographies	Niche but growing

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What FAQS Are Relevant for Industry Stakeholders?

Q1: How does patent expiration influence Ropinirole's revenue?

A1: Patent expiry (~2015) led to significant generic entry, reducing prices and eroding revenues, but increasing volume sales and market access due to affordability.

Q2: What opportunities exist for launching innovative formulations?

A2: Extended-release formulations and patches, improving adherence and convenience, offer significant growth potential.

Q3: How does Ropinirole's safety profile compare with alternatives?

A3: While generally well-tolerated, side effects such as nausea and compulsive behaviors necessitate careful patient monitoring, influencing prescription patterns.

Q4: What is the outlook on Ropinirole in emerging markets?

A4: Growing healthcare infrastructure and aging populations position emerging markets for increased uptake, provided cost-effective generic options are available.

Q5: How do regulatory policies impact new Ropinirole formulations?

A5: Accelerated approvals and favorable regulatory pathways facilitate faster market entry for innovative formulations, boosting competitiveness.

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Key Takeaways

• Market size is currently around USD 1.2 billion globally, with a CAGR of approximately 4.5% forecasted through 2033.
• Patent expiry led to increased generic competition, exerting downward pressure on prices but expanding access.
• Innovative formulations like extended-release and transdermal patches present avenues for premium pricing and growth.
• Emerging markets offer significant growth opportunities, driven by aging populations and increasing disease prevalence.
• Regulatory dynamics favor innovative therapies, but pricing policies especially in cost-conscious markets, remain a challenge.
• Competition from other dopamine agonists and alternative therapies influences market share and pricing strategies.
• Pipeline development, including neuroprotective agents and personalized therapies, will be critical to sustain long-term growth.

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References

1. IQVIA. (2022). The Global Use of Medicine in 2022.
2. Evaluate Pharma. (2023). World Preview 2023: Outlook to 2028.
3. U.S. Food and Drug Administration (FDA). (2017). Approval of Gocovri (amantadine extended-release).
4. Novartis Annual Report. (2019). Requip market analysis.
5. World Health Organization (WHO). (2022). Neurodegenerative Disease Data.