ROPINIROLE HYDROCHLORIDE - Generic Drug Details

What are the generic 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-six 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:	26
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	75
Patent Applications:	3,694
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
Actavis Elizabeth	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090869-002	May 17, 2012	AB	RX	No	No
Orbion Pharms	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	079229-002	Nov 28, 2012	AB	RX	No	No
Sandoz Inc	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201047-006	Jun 6, 2012	AB	RX	No	No
Cosette	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	077460-002	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	ropinirole hydrochloride	TABLET;ORAL	020658-006	Jan 27, 1999	4,452,808
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-006	Jan 27, 1999	4,824,860
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	022008-004	Jun 13, 2008	5,422,123
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-002	Sep 19, 1997	4,452,808

Ropinirole Hydrochloride Market Dynamics and Financial Trajectory (Brand vs Generic, Exclusivity, Pricing, and Revenue Outlook)

Last updated: July 2, 2026

Ropinirole hydrochloride is a long-established dopamine agonist for Parkinson’s disease and restless legs syndrome (RLS). The core market dynamic is loss of brand pricing power after patent and exclusivity expiry, with earnings now driven by (1) generic volume, (2) mix shifts to controlled-release and higher-value formulations, and (3) ongoing payer pressure in the US and Europe. In the US, financial trajectory is largely set by generic share and manufacturer concentration rather than new branded launches.

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What is the current market structure for ropinirole hydrochloride (US, EU, major brands, and generic share)?

Direct answer: The ropinirole hydrochloride market is predominantly generic in most mature geographies. In the US, most revenue is captured by generic manufacturers and authorized generic strategies after brand exclusivity ends. Controlled-release (commonly 24-hour dosing) carries a mix premium versus immediate-release.

Key product forms that drive revenue mix

• Immediate-release tablets (multiple daily dosing)
• Extended-release tablets (once daily, adherence advantage)
• Alternative dose strengths that map to titration schedules in Parkinson’s disease and RLS

Therapeutic demand drivers

• Parkinson’s disease prevalence growth with aging populations
• RLS symptom burden in adults
• Long treatment duration: chronic therapy reduces churn and supports steady baseline demand, even when pricing falls

Supply-side dynamics

• Multiple ANDA filers typically compete on price once the reference product is no longer protected
• Launch sequencing often follows the easiest-to-produce strengths and patient-facing dose strengths

Revenue consequence: After major exclusivity windows close, the financial trajectory tends to shift from brand-like earnings (margin-driven) to generic-like earnings (volume-driven). That pattern is consistent with mature CNS generics.

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How do pricing and reimbursement trends affect ropinirole hydrochloride financial performance?

Direct answer: Pricing is structurally compressed by generic competition and payer step edits, with reimbursement increasingly tied to lowest-cost acquisition and formularies. Extended-release formulations can retain relatively better pricing, but overall economics track the generic basket.

US payer mechanics that influence net price

• Formulary tiering and preferred status for low-cost generics
• Pharmacy benefit manager (PBM) contracting pressure
• Price competition among multiple generic SKUs pushes down WAC-to-net spreads

What typically keeps ropinirole from collapsing faster

• Chronic use and fixed titration pathways create dosing “locks”
• Extended-release keeps a segment willing to pay for reduced dosing frequency, though payers still push generics

Margin outlook

• Generic ropinirole producers face margin compression when inventory cycles are tight or when additional entrants reduce pricing floors
• The controlling variable is not demand growth but the competitive intensity and brand-to-generic replacement timing

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When do ropinirole hydrochloride lose exclusivity in the US and Europe?

Direct answer: Ropinirole hydrochloride is a legacy product; exclusivity and patents on the original reference brand have broadly run out in the US and Europe. Current market behavior is dominated by generic access rather than imminent brand exclusivity cliffs.

Typical exclusivity types that have already played out for legacy small molecules

• Composition-of-matter patent expiration for the original active
• Formulation and process patents (often the last to fall, but still likely expired for this molecule given market maturity)
• Marketing exclusivity (when applicable) and periods tied to earlier filings
• Orange Book-listed patent-by-patent expiry dates for reference product are the determinants for Paragraph IV timing

Why the “cliff” framing matters less now

When exclusivity is already expired, the financial trajectory becomes a function of:

• entrant count
• PBM contracting
• SKU count and coverage
• substitution rates (prescriber and patient switching behavior)

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What is the Orange Book status for ropinirole hydrochloride and which patents are listed?

Direct answer: A complete Orange Book patent-by-patent status requires current Orange Book listings for the specific FDA reference product(s) and dosage forms (immediate-release vs extended-release). Without those live listings, a definitive patent list cannot be provided here.

(Per constraints, no incomplete Orange Book table is included.)

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What patents protect ropinirole hydrochloride formulations and methods of use?

Direct answer: For mature CNS small molecules, patent estates commonly split across:

• composition of matter for the active ingredient (expired for legacy products in many markets)
• controlled-release formulation design (often expired or close to expiry in mature products)
• specific dosing regimens and method-of-use claims (often narrower and frequently litigated or cleared during generic transitions)

What matters for market entry risk: even after composition patents expire, formulation and method-of-use claims can delay generic approval for specific dosage forms or strengths. In practice, the dominant outcome in established markets is full generic entry after those remaining barriers clear.

(Per constraints, no partial or guessed patent numbers are provided.)

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How many ANDA or Paragraph IV challenges exist for ropinirole hydrochloride, and what litigation outcomes matter commercially?

Direct answer: Commercially material patent litigation for ropinirole hydrochloride occurs primarily during the transition from brand to generic. For a legacy product, most early challenges have already resolved, and current financial trajectory is shaped more by the competitive generic landscape than by active, ongoing Paragraph IV disputes.

(Per constraints, no docket-level count or outcome is stated without verified case identifiers.)

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Who are the key generic entrants for ropinirole hydrochloride and how does competition shape revenue trajectory?

Direct answer: The revenue trajectory is shaped by which manufacturers capture a high share of covered formularies and pharmacy channel volume across multiple strengths. Generic leaders typically compete on:

• portfolio breadth across strengths (to win switching)
• price and rebates under PBM contracts
• reliable supply and low stock-out rates
• launch speed following FDA approval

Competitive dynamics to watch

• New entrant frequency tends to reduce net prices quickly
• Consolidation or manufacturing constraints can temporarily stabilize prices
• Contracting cycles change which firms hold “preferred” status

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How does ropinirole compare with alternative Parkinson’s therapies (pricing and formulary placement)?

Direct answer: Ropinirole is one node in a broader Parkinson’s drug network. Its market position is influenced by:

• use as monotherapy in early disease in some treatment algorithms
• add-on use with other dopaminergic agents
• competition with other dopamine agonists and levodopa-based regimens

Formulary substitution patterns

• When payers tighten dopamine agonist coverage, ropinirole may be favored if a preferred generic is priced lowest
• If a competing product is locked in through contracts or rebates, ropinirole volume can soften

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What is the FDA regulatory status for ropinirole hydrochloride (NDA, ANDA, labeling, and pathways)?

Direct answer: Ropinirole hydrochloride is regulated as an already-marketed small-molecule drug. Current supply is primarily through ANDAs for generic versions of the marketed dosage forms, with labeling aligned to reference product indications:

• Parkinson’s disease
• Restless legs syndrome

(Per constraints, no pathway-by-pathway listing is included without referencing specific FDA approval numbers and current labeling versions.)

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What formulation and manufacturing/IP barriers can still delay generic entry?

Direct answer: For a mature molecule, the main residual barriers are not active-ingredient IP but product-specific issues:

• controlled-release performance and dissolution profile validation
• bioequivalence execution for extended-release strengths
• stability and manufacturing robustness across scale-up

Market consequence: Barriers affect which manufacturers launch first and at which strength. Those early movers can capture higher volume before the entrant set expands and prices compress.

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What is the financial trajectory for ropinirole hydrochloride across the product life cycle (brand, generic launch, maturity)?

Direct answer: The trajectory follows a classic generic erosion curve:

1. Brand era: higher prices and higher margins
2. Generic entry: abrupt net price compression after switching
3. Maturity: stable low-to-mid net prices with steady volume, but earnings depend on efficiency and contracting share

Generic maturity implications

• Revenue tends to remain but profitability compresses
• Growth increasingly comes from population and incremental usage, not unit pricing
• Manufacturers win or lose by share, not by category expansion

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What commercial risks exist for investors and licensors in ropinirole hydrochloride?

Direct answer: The risk profile is dominated by generic pricing volatility and regulatory/supply execution rather than brand exclusivity risk.

Key risks

• PBM contracting changes that reassign preferred status
• entry of additional competitors that further compress net pricing
• manufacturing disruptions that reduce supply and create volume share loss
• margin dilution from higher raw material and compliance costs

Upside levers

• being a low-cost, reliable supplier for the PBM-preferred basket
• maintaining a broad strength portfolio to prevent substitution away from the competitor’s SKU gaps
• process improvements that reduce COGS while sustaining BE and product quality

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Key Takeaways

• Ropinirole hydrochloride is a mature CNS franchise with market economics dominated by generic volume and payer-driven net price compression.
• Financial trajectory is driven by mix (immediate-release vs extended-release), contracting share, and supply reliability rather than new branded exclusivity.
• Exclusivity cliffs have largely played out; current commercial outcomes are set by competitive generic intensity.
• Remaining barriers are formulation performance execution and strength-level coverage, which influence launch sequencing and near-term share.

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FAQs

1. Does ropinirole extended-release command a higher market share or price than immediate-release?
   Yes, extended-release typically carries better mix positioning due to adherence advantages, though net pricing still compresses under generic competition.

2. How do PBMs and formularies typically manage generic dopamine agonists like ropinirole?
   They favor preferred generic pricing and tier placement, using rebate and contracting mechanisms to steer volume to lowest-cost SKUs.

3. What factors most affect switching from one ropinirole generic manufacturer to another?
   Preferred formulary status, pharmacy acquisition cost, coverage across dose strengths, and patient stability on a specific formulation.

4. Are there ongoing risks of additional patent or exclusivity barriers for new generic launches?
   Residual risks can exist at the dosage-form or strength level if formulation-specific or method-of-use claims affect labeling or approval scope, but the legacy status means most barriers have already resolved.

5. What supply and manufacturing issues most impact ropinirole sales performance?
   Controlled-release manufacturing robustness, dissolution profile consistency, stability and scale-up execution, and stock-out frequency across multiple strengths.

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References (APA)

1. FDA Orange Book. (n.d.). Drug Products (Approved Drug Products with Therapeutic Equivalence Evaluations). U.S. Food and Drug Administration.
2. FDA. (n.d.). Drug approval reports and labeling for ropinirole-containing products. U.S. Food and Drug Administration.
3. FDA. (n.d.). Approved drug products: ANDA approvals and labeling information. U.S. Food and Drug Administration.