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:	3,664
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
Hikma	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	077852-006	May 5, 2008		DISCN	No	No
Watson Labs Inc	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200431-004	Jun 6, 2012		DISCN	No	No
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-003	Sep 19, 1997		DISCN	Yes	No

Expired US Patents for ROPINIROLE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-003	Sep 19, 1997	4,824,860
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009	5,422,123
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-005	Oct 31, 2008	7,927,624

Market Dynamics and Financial Trajectory for Ropinirole Hydrochloride

Last updated: July 27, 2025

Introduction

Ropinirole hydrochloride, marketed primarily under the brand name Requip among others, is a dopamine agonist primarily used for treating Parkinson’s disease and restless legs syndrome (RLS). Since its first approval in the early 1990s, the drug has established a significant foothold within neurodegenerative disorder management, with evolving market dynamics driven by clinical advancements, regulatory changes, and demographic trends.

This analysis explores the comprehensive market dynamics underpinning ropinirole hydrochloride’s trajectory, including factors influencing its demand, competitive landscape, pricing strategies, and projected financial performance over the next decade.

Market Overview

Therapeutic Indications and Patient Demographics

Ropinirole hydrochloride's primary indications—Parkinson’s disease and RLS—are both neurological disorders with increasing prevalence. Parkinson's affects approximately 1% of individuals over age 60 globally, with projections estimating a rise to over 12 million cases by 2040 [1]. RLS affects roughly 7-10% of the U.S. adult population, often co-occurring with sleep disorders and neurodegenerative conditions [2].

Aging populations in North America, Europe, and parts of Asia fuel the expanding patient base. As these demographics shift, demand for effective dopaminergic therapies like ropinirole is expected to intensify.

Clinical Adoption and Treatment Guidelines

Ropinirole's longstanding efficacy and safety profile have cemented its place in treatment guidelines, often as a first-line therapy for early Parkinson’s and RLS. However, newer agents such as rotigotine transdermal patches and dopamine agonists like pramipexole are providing alternative options, influencing market share dynamics.

Clinicians increasingly adopt personalized treatment regimens, considering side effect profiles, patient comorbidities, and adherence potential. The convenience of oral formulations and once-daily dosing contributes positively to patient compliance, positively affecting market penetration.

Market Drivers

Innovation and Formulation Development

While ropinirole remains primarily available as a capsule, ongoing research into extended-release formulations aims to improve dosing convenience and reduce adverse events. These innovations can prolong patent exclusivity periods, boost sales, and solidify market positioning for producers.

Regulatory Environment and Patent Life Cycle

Patents for innovator brands typically extend approximately 20 years post-filing; however, patent cliffs occur as exclusivity lapses, paving the way for biosimilars and generics. Currently, the leading patents for ropinirole are nearing expiration in major markets like the U.S. and EU, opening avenues for generic competition, which generally leads to price reductions but also increased accessibility.

Regulators' approval for biosimilar or generic versions directly influences pricing and market share, with negotiations and procurement policies shaping revenue streams for incumbent companies.

Competitive Landscape

The market features both branded players—such as GlaxoSmithKline (via Requip)—and generic manufacturers. Biosimilar and generic entries typically lead to price competition, decreasing average selling prices (ASP) and impacting revenue projections for originators.

Furthermore, newer therapies with improved safety profiles or novel administration routes, including transdermal or implantable devices, could someday challenge ropinirole's dominance, demanding continuous innovation and marketing efforts.

Healthcare Market Trends and Reimbursement

Healthcare systems worldwide are emphasizing cost-effective treatments. Governments and insurers favor generics and biosimilars, exerting downward pressure on drug pricing. Reimbursement policies, coverage decisions, and formulary placements critically affect market penetration.

In regions where reimbursement is contingent on cost-effectiveness, the availability of lower-priced generics post-patent expiry is a pivotal factor in long-term revenues.

Market Challenges

Side Effects and Safety Profile

Ropinirole is associated with adverse effects such as orthostatic hypotension, nausea, and impulse control disorders, which can limit its tolerability. The emergence of newer agents with marginally better safety profiles influences prescriber preferences.

Patient Adherence and Compliance

The onset of side effects can diminish adherence, adversely affecting real-world efficacy and market demand. The development of extended-release formulations aims to mitigate these issues, but they also face challenges related to manufacturing complexity and regulatory approval.

Emerging Therapies and Technological Disruption

Gene therapies, deep brain stimulation, and novel pharmacological agents represent future discontinuities that may cannibalize current dopamine agonist markets. Staying abreast of such technological shifts is crucial for market players.

Financial Trajectory and Forecast

Revenue Projections

Pre-patent expiry, the annual global sales of ropinirole are estimated at approximately $800 million, with North America and Europe constituting the majority share [3]. Post-patent expiry, generic versions significantly reduce ASPs, with industry estimates projecting a 50-70% decline in unit prices within 2-3 years, contributing to a corresponding drop in revenues.

However, the introduction of extended-release formulations and new formulations may temporarily sustain or increase revenues, counteracting the decline caused by generics. For example, branded formulations often retain higher pricing power for several years post-patent expiry due to clinical differentiation.

Profitability and Investment Outlook

Pharmaceutical companies anticipate declining margins for ropinirole following patent expiration but offset this through pipeline diversification, development of next-generation therapies, and value-added services such as monitoring programs.

Research and development investments into combination therapies, delivery systems, and personalized medicine are central to extending product life cycles and capturing new revenue streams.

Market Opportunities

Emerging markets present substantial growth potential, driven by increasing Parkinson’s and RLS prevalence and expanding healthcare infrastructure. Demand for affordable generics can sustain revenues for patent holders through licensing agreements and strategic partnerships.

Additionally, digital health integration—such as remote monitoring and adherence support—can differentiate products and sustain their relevance in a rapidly evolving healthcare environment.

Strategic Recommendations

• Pipeline Diversification: Invest in formulation innovations, combination therapies, and novel delivery systems to extend market dominance.
• Regulatory Vigilance: Monitor patent landscapes and prepare for biosimilar entries, optimizing lifecycle management.
• Pricing Strategies: Balance competitive pricing with maintaining profitability, especially in emerging markets.
• Market Expansion: Focus on underserved regions with rising aging populations to capitalize on demographic trends.
• Clinical Differentiation: Emphasize safety profiles and patient adherence advantages to sustain prescriber preference.

Conclusion

Ropinirole hydrochloride’s market trajectory is shaped by patent expiries, demographic shifts, technological advances, and healthcare policy trends. While impending patent cliffs threaten short-term revenues, strategic innovation, market diversification, and healthcare system adaptations can reinforce its role within neurodegenerative disorder management. Firms should proactively navigate patent landscapes, cultural market nuances, and evolving clinical guidelines to optimize future financial performance.

---

Key Takeaways

• Demographic trends and increasing prevalence of Parkinson’s disease and RLS underpin strong long-term demand.
• Patent expiries will catalyze significant price erosion, prompting reliance on generic competition.
• Innovation in formulations and combination therapies can initiate new revenue streams and prolong product lifecycle.
• Emerging therapies and technological disruption pose ongoing threats, necessitating continuous R&D investment.
• Market expansion into emerging economies offers substantial growth opportunities despite pricing pressures.

---

FAQs

1. When are the primary patents for ropinirole hydrochloride expected to expire?
Most key patents are approaching their expiration in the next 2-3 years in major markets like the US and EU, opening the door for biosimilar and generic competition (sources: [4]).

2. How will generic entry impact the global sales of ropinirole?
Generic competition will likely lead to a 50-70% reduction in ASPs within 2-3 years post-patent expiry, substantially decreasing revenues, but can also increase overall market volume and accessibility.

3. Are there any new formulations or delivery methods in development for ropinirole?
Yes, extended-release formulations are under development and some have gained regulatory approval, aiming to improve adherence and reduce adverse effects.

4. What emerging therapies threaten ropinirole’s market share?
Gene therapies, deep brain stimulation, and newer dopamine agonists with improved safety profiles could potentially replace oral ropinirole in clinical practice.

5. How significant are demographic trends in shaping the market for ropinirole?
Very significant. Aging populations globally increase the prevalence of Parkinson's and RLS, sustaining and expanding demand over the upcoming decades.

---

Sources:

1. Parkinson’s Foundation. (2021). Parkinson’s Disease Statistics.
2. Allen RP, Picchietti DL, Hening WA, et al. Restless legs syndrome/Willis-Ekbom disease: clinical guidelines, diagnosis, and management. Sleep. 2014;37(8):1253-1274.
3. MarketWatch. (2022). Ropinirole Hydrochloride Drugs Market Analysis.
4. FDA. (2022). Patent expiration timelines for Parkinson’s medications.