Last Updated: June 25, 2026

REQUIP XL Drug Patent Profile


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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-five suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

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Recent Clinical Trials for REQUIP XL

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

SponsorPhase
Titan PharmaceuticalsPhase 1/Phase 2
Vanderbilt University Medical CenterPhase 4
Seoul National University HospitalPhase 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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-006 Apr 10, 2009 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-002 Jun 13, 2008 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 022008-004 Jun 13, 2008 ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-004 Jun 13, 2008 ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-002 Jun 13, 2008 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for REQUIP XL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0299602 SPC/GB96/040 United Kingdom ⤷  Start Trial PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
0299602 97C0036 Belgium ⤷  Start Trial PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Last updated: June 19, 2026

Requip XL (ropinirole extended-release) Market Dynamics and Financial Trajectory

Executive summary: Requip XL (ropinirole extended-release) has a mature, low-growth market profile typical of older CNS brands with patent-driven erosion risk. Its financial trajectory has been shaped by (1) long-term substitution pressure from generic immediate-release ropinirole, (2) formulary and payer tiering shifts driven by cost, and (3) limited late-cycle differentiation versus other Parkinson’s disease (PD) motor-symptom therapies. Public financial visibility is constrained by how the product is reported within broader company segments and by the availability of product-level data; however, Requip XL’s commercial pathway tracks the broader pattern of CNS brand plateau and then gradual decline under generic competition and switching.


What is the commercial positioning of Requip XL in Parkinson’s disease?

Requip XL is a dopamine agonist indicated for the treatment of Parkinson’s disease motor symptoms. In commercial terms, it sits in the dopamine agonist class alongside immediate-release ropinirole and other agents (for example, pramipexole immediate release and extended release, rotigotine patch). Its extended-release formulation historically targeted adherence and dosing convenience versus multiple daily dosing alternatives.

How does Requip XL compete for formulary access?

Formulary placement for PD motor-symptom therapies typically hinges on:

  • Total daily dose equivalence versus alternatives
  • Side-effect profile and patient tolerability (dopamine agonist class effects include nausea, dizziness, somnolence, and hallucinations)
  • Payer preference for lower-cost generics once available in the class
  • Budget impact relative to other PD options (levodopa regimens, MAO-B inhibitors, COMT inhibitors, and combination strategies)

For mature PD brands, the competitive center of gravity shifts from “clinical differentiation” to “dosing convenience and cost,” and then to “generic substitution.” That pattern typically compresses unit growth and forces discounting.


How have generic ropinirole and class competition affected Requip XL sales?

Featured snippet answer: Requip XL faces sustained pricing pressure from generic immediate-release ropinirole and broader PD class competition, which typically drives volume substitution and lowers net sales via discounting and tiering.

What are the substitution dynamics inside the ropinirole molecule?

The active ingredient ropinirole has long-standing generic availability in immediate-release forms in most markets, which changes payer behavior:

  • Payers often steer to the cheapest therapeutically equivalent option.
  • Clinicians may still use extended-release products for adherence or tolerability, but switching tends to accelerate with each payer policy refresh.

Even when extended-release maintains some share, the “ceiling” on growth is limited because the principal economic advantage becomes dosing frequency rather than unique pharmacology.

What external PD competitors can pressure Requip XL?

Payer and clinician selection in PD motor symptoms often compares dopamine agonists across:

  • Dose flexibility and adverse event burden
  • Convenience (extended-release tablets versus patch delivery)
  • Avoidance of drug interactions and titration burden
  • Patient-specific factors like daytime somnolence risk

In practice, when generics suppress pricing for at least one dopamine agonist segment, the rest of the class experiences margin compression and increased discounting pressure.


When did Requip XL enter the generic erosion phase, and what does that imply financially?

Featured snippet answer: Requip XL’s generic erosion risk rises as relevant patent protection (composition, formulation, and method-of-use depending on the estate) ends, and once payer contracts and internal protocols shift toward generic substitution.

How does patent endgame translate into sales trajectory?

A typical mid-to-late lifecycle sequence for a branded CNS product is:

  1. Formulary tightening ahead of generic launch: increased prior authorization, step therapy, and higher co-pays.
  2. Launch of generics or AB-rated equivalents: net price declines first, unit declines follow as prescribers switch.
  3. Post-launch consolidation: remaining share is held by a smaller patient subset with adherence or tolerability needs.

For Requip XL, this translates into:

  • Slower decline after early erosion due to extended-release preference in some patients
  • A later step-change when additional payer policies or broader AB substitution becomes entrenched

What is Requip XL’s financial trajectory under typical CNS brand economics?

Featured snippet answer: Mature CNS brands generally show flattening or declining net sales over time due to generic substitution and payer behavior; margin typically compresses as discounting increases to protect share.

Revenue and margin mechanics likely affecting Requip XL

For older Parkinson’s CNS brands, the financial trajectory is usually driven by:

  • Net price pressure: rebates and discounts increase to retain formulary position.
  • Mix effects: loss of higher-reimbursement patients to generic alternatives reduces ASP.
  • Cost increases per unit: sales and marketing spend often stays relatively fixed while volume declines, worsening operating leverage.
  • Channel consolidation: fewer entities actively pushing the product as prescribers migrate.

How to read the trajectory without product-level reporting

When a company reports only aggregated neurology or CNS categories, Requip XL’s contribution is inferred through:

  • Category declines after generic entry in the relevant molecule
  • Shifts in “Other” or “U.S. branded” performance segments
  • Payer and formulary updates impacting the dopamine agonist class

This still supports a high-confidence strategic conclusion: after generic availability in the core active ingredient, the branded extended-release product tends to follow a declining revenue curve with intermittent stabilization.


What market share and pricing risks exist for Requip XL going forward?

Featured snippet answer: The principal forward risk is further share loss as payers broaden policies favoring AB-rated generics and as clinical practice aligns around the lowest-cost dopamine agonist strategies.

Key risk drivers

  • Payer switch behavior: expanding step edits or requiring trial of immediate-release generics before allowing extended-release.
  • Contract renegotiations: annual payer contract cycles can trigger price resets and rebate realignment.
  • Physician prescribing patterns: neurologists may retain extended-release for selected patients, but panel effects favor generics as baseline.
  • Pipeline substitution: if competitors or newer PD therapies improve convenience or tolerability, they can take share from dopamine agonists.

How does Requip XL compare with Requip (immediate-release ropinirole) in market dynamics?

Featured snippet answer: Requip (immediate-release) is usually more exposed to generic substitution economics, while Requip XL historically benefits from extended-release convenience but still loses share to the lowest-cost AB-rated alternatives.

Practical comparison: competitive outcomes

  • Immediate-release ropinirole: higher generic availability and stronger payer steering to cheapest option.
  • Extended-release ropinirole (Requip XL): some persistence from adherence and tolerability needs, but it remains vulnerable to broad payer preference for any AB-rated ropinirole product.

Financially, extended-release products can sometimes maintain a higher net-to-gross ratio than immediate-release branded products before fully collapsing, but once payer policies normalize, both converge in price pressure.


What patent estate issues most affect Requip XL’s long-term financial outlook?

Featured snippet answer: The key estate risks are expiration and invalidity of formulation and dosing-release patents plus method-of-use coverage. Once those are no longer enforceable, generic competition accelerates and pricing compresses.

Where do patent estates usually matter most for extended-release products?

Extended-release products typically have patent clusters around:

  • Formulation and release mechanism
  • Matrix or coating systems controlling drug release rate
  • Use patterns in PD management (if separately protected)
  • Manufacturing methods tied to the release profile

When those components lapse, competitors can design around and enter with AB-equivalent formulations.


What Orange Book status issues affect generic entry timing for Requip XL?

Featured snippet answer: Generic entry timing is governed by the Orange Book-listed patents and listed periods for each approved strength and dosage form, plus whether any Paragraph IV challenges were filed.

What matters for entry risk analysis

  • Presence of multiple listed patents often delays generic entry if any remain enforceable.
  • Absence or early expiration reduces barrier height.
  • Settlements can extend time through agreed “carve-outs” or non-launch commitments, if present.

Because the prompt requests market dynamics and financial trajectory without providing the Orange Book patent list for Requip XL, no specific listing-based conclusions can be stated here.


Has any Paragraph IV litigation or settlement impacted Requip XL’s revenue?

Featured snippet answer: Paragraph IV litigation and any ensuing settlements typically produce revenue “bumps” by delaying launch, but long-term financial outcomes still trend downward after generic entry becomes inevitable.

Financial impact pathways

  • Delay effect: post-launch delay keeps branded product net price higher for longer.
  • Settlement terms: launch carve-outs can shift entry timing across strengths.
  • Post-settlement aftermath: once entry occurs, the brand often experiences a faster unit decline than price erosion alone would predict.

Without specific docketed filings and settlement dates for Requip XL, no case-specific timeline can be provided.


What is the FDA regulatory and substitution landscape for Requip XL?

Featured snippet answer: Once AB-rated alternatives exist, FDA permissibility combined with payer contracts drives therapeutic substitution and net sales erosion.

Regulatory factors that influence market behavior

  • FDA rating of generic and AB equivalence for ropinirole products
  • Labeling-based switching: if extended-release dosing is interchangeable for key patient populations
  • Titration and titration tolerability constraints can slow switching in some patients

Overall, FDA approval mechanics set the floor for substitution, but payers determine the pace.


Commercial scenario modeling: what do generic launch and payer changes do to unit economics?

Featured snippet answer: Generic launch usually causes immediate net price decline followed by volume loss, producing a steep revenue drop in the first 6 to 18 months post-entry.

Scenario table

Scenario What changes Expected near-term impact (0-12 months) Longer-term effect (1-3 years)
Tightened payer policy Step edits for extended-release, preferred generic ropinirole Net price declines; unit stability briefly then drops Persistent share loss, ongoing margin compression
Generic expansion across strengths More AB-rated products available Faster unit decline across portfolio Reduced ability to sustain premium pricing
Limited clinical switching Patient subset remains on extended-release Smaller volume loss, price erosion dominates Slower decline curve but still downward
Competitive displacement by other PD options Dose/patch/adjunct strategy shifts Share erosion slower than generic entry, but additive Sustained market share pressure, higher promotional spend burden

This structure is consistent with older CNS brands once class generics and payer steering take hold.


Key Takeaways

  • Requip XL’s market dynamics align with an older CNS brand facing sustained payer and generic substitution pressure from ropinirole AB equivalents.
  • Financial trajectory typically trends from plateau to gradual decline, with sharper drops when payer policies tighten or when additional AB-rated options expand across strengths.
  • Extended-release convenience helps retain a subset of patients, but it rarely offsets the economics of generic availability once payers steer to the lowest-cost alternatives.
  • Patent and Orange Book dynamics determine timing of generic entry, while litigation and settlements determine delay, not reversal of long-term erosion.

FAQs

1) What drives payer preference between ropinirole extended-release and immediate-release?
Cost tiering, AB-rated availability, and step-therapy rules; clinical titration and tolerability can slow switching but rarely prevent it.

2) Do extended-release formulations protect brands from generic erosion?
They can delay erosion if specific formulation-release patents remain enforceable, but once AB-equivalent generics are established and payers steer, extended-release typically loses price and share.

3) How long after generic entry do CNS brands usually lose the most volume?
Often within 6 to 18 months as prescribers and pharmacy benefit managers adjust to contract changes and prescribing inertia breaks.

4) Does Parkinson’s treatment strategy affect the long-term demand for dopamine agonists like Requip XL?
Yes. Treatment algorithms and combination strategies can shift patients toward or away from dopamine agonists depending on tolerability and symptom profile.

5) What commercial signal best predicts continued erosion for Requip XL?
Ongoing formulary tightening (prior authorization, step edits) and widening payer preference for lowest-cost AB-rated ropinirole products.


References

No sources were cited because no Requip XL patent listings, FDA application details, litigation records, or product-level financial disclosures were provided in the prompt.

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