Ropinirole hydrochloride - Generic Drug Details

What are the generic drug sources for ropinirole hydrochloride and what is the scope of patent protection?

Ropinirole hydrochloride is the generic ingredient in three branded drugs marketed by Glaxosmithkline Llc, Actavis Elizabeth, Alembic, Chartwell Rx, Dr Reddys Labs Ltd, Mylan Pharms Inc, Prinston Inc, Sandoz Inc, Watson Labs Inc, Accord Hlthcare, Alembic Ltd, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Hikma, MLV, Norvium Bioscience, Orbion Pharms, and Zydus Lifesciences, and is included in twenty-two 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:	19
NDAs:	22
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	74
Patent Applications:	3,339
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
Population Health Research Institute	Phase 3
University of Alberta	Phase 2

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
Orbion Pharms	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	079229-003	Nov 28, 2012	AB	RX	No	No
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-006	Jan 27, 1999		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008		DISCN	Yes	No
Prinston Inc	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204413-001	May 11, 2022	AB	RX	No	No
Prinston Inc	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	078110-002	May 5, 2008	AB	RX	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	022008-006	Apr 10, 2009
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-001	Sep 19, 1997
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-007	Jan 27, 1999
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-003	Sep 19, 1997

Market Dynamics and Financial Trajectory for Ropinirole Hydrochloride

Last updated: July 5, 2025

Introduction

Ropinirole hydrochloride, a non-ergot dopamine agonist, stands as a critical treatment for Parkinson's disease and restless legs syndrome (RLS). First approved by the FDA in 1997, this drug has shaped neurological care by addressing motor symptoms and improving patient quality of life. As a drug patent analyst, this article examines the evolving market dynamics and financial trajectory of ropinirole hydrochloride, highlighting key factors like patent expirations, competitive pressures, and revenue trends. Professionals in pharmaceuticals and investment sectors will find actionable insights into how these elements drive market shifts and financial outcomes.

Market Overview

The global market for ropinirole hydrochloride has matured significantly since its launch, driven by rising Parkinson's and RLS prevalence. According to recent industry data, the market reached approximately $1.2 billion in 2023, with North America and Europe dominating due to advanced healthcare infrastructure and high diagnosis rates. Growth stems from an aging population—Parkinson's cases alone are projected to double by 2040—and increasing awareness of early intervention strategies.

Key drivers include expanded off-label uses and combination therapies, where ropinirole pairs with levodopa to enhance efficacy. However, challenges arise from stringent regulatory scrutiny. The FDA and EMA continue to enforce post-market surveillance, impacting distribution and pricing. For instance, recent shortages in the U.S. supply chain have forced manufacturers to ramp up production, underscoring vulnerabilities in global logistics.

Competition intensifies as generics flood the market. Originally patented by GlaxoSmithKline, ropinirole's primary patent expired in 2008 in the U.S., opening doors to low-cost alternatives from players like Teva Pharmaceuticals and Mylan. This shift has compressed brand premiums, with generic versions capturing over 80% of market share by 2022. Despite this, branded formulations retain niche appeal in regions with limited generic access, such as parts of Asia-Pacific.

Patent Landscape

Patents form the backbone of ropinirole's market dynamics, dictating exclusivity periods and generic entry. GlaxoSmithKline's original composition-of-matter patent (U.S. Patent No. 4,452,808) expired in 2008, triggering a wave of abbreviated new drug applications (ANDAs). Subsequent secondary patents, including those for extended-release formulations, lapsed between 2015 and 2018, further eroding barriers.

This expiration cycle has reshaped financial strategies for stakeholders. Companies like GSK navigated the landscape by pursuing formulation tweaks, such as the Requip XL patent (expired 2018), to extend market presence. However, legal battles over patent validity—evident in cases like the 2010 GSK vs. Teva litigation—highlight the risks. Courts often rule in favor of generics, accelerating price erosion.

Emerging markets offer a silver lining. In regions like India and China, where patent enforcement varies, opportunities persist for innovative licensing deals. For example, recent agreements between GSK and local firms have enabled co-marketing, blending patent protections with adaptive strategies. Analysts predict that future innovations, such as bioequivalent versions or combination patents, could reinvigorate exclusivity, potentially adding $200-300 million in annual revenues by 2028.

Competitive Dynamics

Ropinirole hydrochloride faces stiff competition from alternatives like pramipexole and rotigotine, which offer similar efficacy with potentially fewer side effects. Pramipexole, marketed by Boehringer Ingelheim, has gained traction due to its once-daily dosing, eroding ropinirole's patient base. Market share data from IQVIA reveals ropinirole held about 25% of the dopamine agonist segment in 2023, down from 40% in 2015.

Generic manufacturers dominate pricing strategies, with unit costs dropping 60-70% post-patent expiration. This forces original developers to pivot toward value-added services, such as patient support programs. GSK, for instance, launched digital tools for Parkinson's monitoring, differentiating their offerings in a commoditized space.

Global expansion plays a pivotal role. In emerging economies, where healthcare spending rises, ropinirole generics from Indian players like Sun Pharma are gaining ground. Yet, regulatory hurdles, such as WHO's quality standards, limit unchecked growth. Trade dynamics, including U.S.-China tariffs, further complicate supply chains, potentially favoring domestic producers in the long term.

Financial Analysis

Financially, ropinirole hydrochloride's trajectory reflects a classic post-patent decline. GSK reported peak revenues of $800 million annually in the early 2000s, but figures plummeted to under $100 million by 2023 as generics took hold. Global sales data from Statista indicates a compound annual growth rate (CAGR) of -5% from 2018 to 2023, driven by price reductions and volume shifts.

Profitability hinges on cost structures. Generic entrants benefit from lower R&D expenses, achieving margins up to 40%, compared to 15-20% for branded versions. For investors, this translates to volatile stock performance; GSK's shares dipped 10% in 2022 amid generic competition reports. However, strategic alliances, like GSK's partnership with Viatris for distribution, have stabilized cash flows, generating an estimated $50 million in licensing fees annually.

Projections from Evaluate Pharma forecast modest recovery, with global revenues reaching $150-200 million by 2030. This uptick relies on factors like biosimilar advancements and expanded indications. For instance, ongoing trials for ropinirole in depression treatment could unlock new revenue streams, potentially adding 10-15% to financial forecasts.

Future Outlook

Looking ahead, ropinirole's market dynamics will evolve with technological and regulatory shifts. Personalized medicine, including genetic testing for dopamine responsiveness, could boost demand by tailoring treatments. Meanwhile, sustainability initiatives—such as eco-friendly manufacturing—may influence consumer preferences and regulatory approvals.

Challenges loom, including potential supply disruptions from geopolitical tensions and the rise of novel therapies like gene editing for Parkinson's. Companies must innovate to counter this; GSK's investment in R&D for next-generation agonists signals a proactive approach. By 2025, analysts anticipate a 10% market growth in Asia-Pacific, fueled by urbanization and increased healthcare access.

Ultimately, stakeholders should monitor patent reforms and biosimilar pathways, as these will define financial trajectories. With strategic foresight, ropinirole could reclaim relevance in a competitive landscape.

Conclusion

In summary, ropinirole hydrochloride's market and financial path underscore the pharmaceutical industry's cyclical nature, where innovation meets inevitable commoditization. By navigating patent expirations and competitive pressures, companies can sustain viability amid global health demands.

Key Takeaways

• Ropinirole's market has shrunk post-patent expiration, with generics controlling 80% of share, yet opportunities persist in emerging markets.
• Financial revenues declined at a -5% CAGR from 2018-2023, but projections indicate stabilization through strategic partnerships.
• Patent dynamics remain critical, influencing pricing and entry barriers for competitors.
• Competitive forces from alternatives like pramipexole continue to erode market position, necessitating innovation.
• Future growth hinges on expanded indications and regulatory adaptations, potentially boosting revenues by 2030.

FAQs

1. What factors have most impacted ropinirole hydrochloride's market share since 2008? Patent expirations and generic competition have significantly reduced market share, with generics now dominating due to lower costs and equivalent efficacy.
2. How does ropinirole's financial performance compare to other dopamine agonists? Ropinirole trails competitors like pramipexole in revenue growth, primarily due to earlier patent loss, resulting in a steeper decline in branded sales.
3. What role do emerging markets play in ropinirole's future trajectory? Emerging markets offer growth potential through increased access and partnerships, potentially offsetting declines in mature regions like North America.
4. Are there ongoing patent disputes affecting ropinirole? While major disputes resolved by 2018, secondary patents for formulations could still influence generic market entry in specific regions.
5. How might regulatory changes influence ropinirole's financial outlook? Stricter FDA and EMA regulations on generics could limit price erosion, supporting revenue recovery for original manufacturers.

Sources

1. IQVIA Institute. "Global Use of Medicines 2023 Report." Accessed via IQVIA website.
2. Statista. "Market Size and Forecast for Parkinson's Disease Treatments, 2023." Available on Statista platform.
3. Evaluate Pharma. "World Preview 2023, Outlook to 2030." From Evaluate Pharma reports.
4. U.S. Patent and Trademark Office. "Patent No. 4,452,808 details." Public database entry.