CLINICAL TRIALS PROFILE FOR MIRAPEX ER

All Clinical Trials for MIRAPEX ER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00025792 ↗	Clinical Trial of Pramipexole in Bipolar Depression	Completed	National Institute of Mental Health (NIMH)	Phase 2	2001-10-01	The purpose of this study is to examine the safety and effectiveness of the drug pramipexole given in combination with lithium or divalproex for the short-term treatment of acute depression in patients with bipolar disorder. Bipolar disorder is a severe, chronic, and often life-threatening illness. Treatments for acute unipolar depression have been extensively researched. However, despite the availability of a wide range of antidepressant drugs, a significant proportion of depressed patients fail to respond to first-line antidepressant treatment. Novel and improved therapeutics for bipolar depression are needed. This study will evaluate the antidepressant properties of pramipexole. This study will be conducted in three phases. Phase 1 is a 14-day washout period in which participants will be tapered off all their psychiatric medicines except divalproex or lithium. Participants will also be asked to adhere to a low caffeine and low monoamine diet. During Phase 2, participants will be randomly assigned to receive either pramipexole or placebo (an inactive pill) for 6 weeks. Participants who respond to treatment will be given either open-label pramipexole or another clinical treatment. Participants will be screened with a medical history, physical examination, electrocardiogram (EKG), blood and urine tests, and a psychiatric evaluation. Women of childbearing potential will have a pregnancy test. Participants will have a physical exam and EKG at study entry and study completion. Blood will be drawn at various times throughout the study. Pulse and blood pressure measurements will be taken daily. Weekly interviews will be conducted. Participants and a control group of healthy volunteers will undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) scans of the brain.
NCT00040209 ↗	JP-1730 to Treat Parkinson's Disease	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2002-06-01	This study will evaluate the effects of an experimental drug called JP-1730 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. JP-1730 affects chemical messengers believed to affect Parkinson's disease symptoms. Patients between 30 and 80 years of age with relatively advanced Parkinson's disease may be eligible for this 3-phase study. - Phase 1 - Baseline evaluation Participants will be evaluated with a medical history, physical examination, detailed neurologic evaluation, routine blood tests, urinalysis and an electrocardiogram. They will also have a 24-hour holter monitor (heart monitoring) and cardiology consultation. A chest X-ray and MRI or CT scan of the brain will be done if needed. Patients will, if possible, stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before the study begins and throughout its duration. (If necessary, patients may use short-acting dopamine agonists, such as Mirapex and Requip.) - Phase 2 - Dose Finding Phase For 2 to 3 days, patients will be admitted to the NIH Clinical Center for a levodopa (a dopamine agonist) dose-finding procedure. For this procedure, patients stop taking Sinemet and instead have levodopa, and subsequently apomorphine, infused through a vein. During the infusions, the drug dose is increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Symptoms are monitored frequently to find the optimal dose. (Patients who have had dosing infusions in the last 3 months will not have to undergo this phase of the study.) - Phase 3 - Active Study Phase Within 3 months of the dose-finding phase, treatment will begin. Patients will receive seven doses of JD-1730 or placebo (an inactive substance) via puffs from an oral spray together with levodopa infusions over a 3-week period. The doses are given on days 1, 2, and 3 of the first week and then approximately twice a week for the next 2 weeks. For these doses, patients are hospitalized 4 days the first week and 2 days each for the next 2 weeks. All participants will receive placebo at some time during the study, and a few patients, selected at random, will receive only placebo the entire 3 weeks. The procedure for the infusions is the same as that for the dose-finding phase, with frequent evaluation of symptoms. Also, small blood samples are drawn up to three times each study day. At the end of the third week, patients will be discharged from the hospital. Their anti-parkinsonian medications may be readjusted, as needed. Patients will be contacted 2 weeks after the end of the study for a check on side effects and, if necessary, will be scheduled for a follow-up evaluation at the clinic. In addition to the above procedures, patients will be asked to have an optional lumbar a puncture (spinal tap) on the first and last days of the study to measure various brain chemicals and drug levels that cannot be measured in blood and urine. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle.
NCT00076674 ↗	Levetiracetam Treatment of L-dopa Induced Dyskinesias	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2004-01-01	This study will evaluate the effects of levetiracetam (Keppra (Trademark) on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. Levetiracetam blocks certain protein receptors on brain cells and thus can change the spread of brain signals believed to be affected in patients with Parkinson's disease. Patients between 30 and 80 years of age with relatively advanced Parkinson's disease and dyskinesias due to levodopa therapy may be eligible for this 6-week study. Screening and baseline evaluation - Participants are evaluated with a medical history, physical examination and neurologic evaluation, blood tests, urinalysis, electrocardiogram (EKG), 24-hour holter monitor (heart monitoring), and cardiology consultation. A chest x-ray and MRI or CT scan of the brain are done if needed. If possible, patients stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month (2 months if taking Selegiline) before the study begins and throughout its duration. (If necessary, patients may use short-acting agents, such as Mirapex, Requip or Amantadine.) Dose-finding phase - Patients are admitted to the NIH Clinical Center for 2 to 3 days for a levodopa "dose-finding" procedure. For this test, patients stop taking Sinemet and instead have levodopa infused through a vein. During the infusions, the drug dose is increased slowly until parkinsonian symptoms improve or unacceptable side effects occur or the maximum study dose is reached. Symptoms are monitored frequently. (Patients who have had dosing infusions in the last 3 months do not have to undergo this phase of the study.) Active study phase - Patients are randomly assigned to take levetiracetam or placebo ("sugar pill") twice a day for 6 weeks. At the end of weeks 1, 2 4, and 5, patients come to the clinic for blood tests, an EKG, and a review of adverse side effects. At the end of weeks 3 and 6, patients are hospitalized to study the response to treatment. They again stop taking Sinemet and selegiline and their ability to perform motor tasks is evaluated. They are then placed on an L-dopa infusion for 10 hours. Placebo may be infused at various times instead of L-dopa. Motor symptoms are evaluated several times during the infusion. Blood is drawn once during the infusion for research studies. Lumbar puncture - Patients undergo a lumbar puncture (spinal tap) at the end of weeks 1 and 4 to measure certain brain chemicals and drug levels. For this test, a local anesthetic is given and a needle is inserted in the space between the vertebrae in the lower back. About 2 tablespoons of fluid is collected through the needle. Magnetic resonance imaging (MRI) - Patients with changing disease activity may undergo MRIs at baseline, at the end of week 1 and at the end of the study to show changes in the brain. The patient lies in a narrow cylinder (the scanner) that uses radio waves and a magnetic field to produce images of the brain, which show structural and chemical changes. Follow-up - 2 weeks after the study ends, patients are contacted by phone for a review of side effects or they return to the clinic for an evaluation.
NCT00086294 ↗	ACP-103 to Treat Parkinson's Disease	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2004-06-25	This study will evaluate the effects of an experimental drug called ACP-103 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term levodopa treatment. ACP-103 changes the spread of certain brain signals that are affected in patients with Parkinson's disease. Patients with relatively advanced Parkinson's disease and dyskinesias who are between 30 and 80 years of age may be eligible for this study. Candidates are screened with a complete medical history and physical examination, neurological evaluation, blood and urine tests, and electrocardiogram (ECG). A brain magnetic resonance imaging (MRI) scan, CT scan, and chest x-ray may be done if medically indicated. Patients enrolled in the study will, if possible, stop taking all antiparkinsonian medications for one month (2 months for Selegiline) before the study begins and throughout its duration. Exceptions are Sinemet (levodopa/carbidopa), Mirapex (pramipexole) and Requip (ropinirole). Levodopa Dose Finding After the screening evaluations, patients are admitted to the NIH Clinical Center for 2 to 3 days to undergo a levodopa "dose-finding" procedure. For this test, patients stop taking Sinemet and instead have levodopa infused through a vein. During the infusion, the drug dose is increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Side effects are monitored closely during the infusions, and parkinsonian symptoms are evaluated frequently during and after the infusions. The infusions usually begin early in the morning and continue until evening. Once the infusion is finished, patients resume taking their regular oral Sinemet dose. The infusions are repeated once a week during 1-day inpatient evaluations. Treatment Patients are randomly assigned to take either ACP-103 followed by placebo (a look-alike pill with no active ingredient) once a week for 10 weeks or vice versa (placebo followed by ACP-103). Patients are admitted to the Clinical Center for each dose. During this admission they have a brief medical examination, blood and urine tests, ECG, and review of symptoms or changes in their condition. They also have an infusion of levodopa (see above) at the previously determined optimal rate. Parkinsonism symptoms and dyskinesias are evaluated every 30 minutes for about 6 hours. At the end of the infusions and ratings, patients are discharged home with their regular Parkinson's medications until the following visit. Two weeks after their final dose of ACP-103 or placebo, patients are contact by telephone for a follow-up safety check. At that time, the investigator may ask the patient to return to the clinic for closer evaluation.
NCT00096720 ↗	Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease	Completed	Boehringer Ingelheim	Phase 2	2004-02-01	Study participants who have been clinically diagnosed with Parkinson disease will receive no treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12 weeks. Over the course of the study subjects will travel to the Institute for Neurodegenerative Disorders (IND) in New Haven, Connecticut for brain imaging.

Clinical Trial Conditions for MIRAPEX ER

Condition Name

Condition Name for MIRAPEX ER
Intervention	Trials
Parkinson Disease	9
Restless Legs Syndrome	6
Parkinson's Disease	5
Bipolar Disorder	3

Condition MeSH

Condition MeSH for MIRAPEX ER
Intervention	Trials
Parkinson Disease	15
Restless Legs Syndrome	7
Psychomotor Agitation	7
Syndrome	5

Clinical Trial Locations for MIRAPEX ER

Trials by Country

Trials by Country for MIRAPEX ER
Location	Trials
United States	173
Canada	9
Spain	4
Finland	3
Italy	3

Trials by US State

Trials by US State for MIRAPEX ER
Location	Trials
Maryland	11
New York	10
Massachusetts	10
California	9
Florida	8

Clinical Trial Progress for MIRAPEX ER

Clinical Trial Phase

Clinical Trial Phase for MIRAPEX ER
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for MIRAPEX ER
Clinical Trial Phase	Trials
Completed	25
Unknown status	4
Terminated	1

Clinical Trial Sponsors for MIRAPEX ER

Sponsor Name

Sponsor Name for MIRAPEX ER
Sponsor	Trials
Boehringer Ingelheim	7
National Institute of Neurological Disorders and Stroke (NINDS)	4
National Institute of Mental Health (NIMH)	3

Sponsor Type

Sponsor Type for MIRAPEX ER
Sponsor	Trials
Other	22
Industry	20
NIH	8

Last updated: May 21, 2026

MIRAPEX ER (Pramipexole Extended-Release) clinical trials update, market analysis, and exclusivity timeline

Executive summary: MIRAPEX ER (pramipexole extended-release) is an established oral dopamine agonist for Parkinson’s disease (PD) and is evaluated in late-stage clinical programs mainly around label expansion and comparative positioning versus other dopamine agonist options and Parkinson’s therapies. Patent and regulatory controls in the U.S. are driven by pramipexole-related compositions and formulations plus method-of-use coverage; any U.S. commercial “new generic risk” depends on Orange Book patent status and whether ANDA filers target unexpired, non-expired, or carve-out patents (Paragraph IV). Market outlook is constrained by (1) aging cohort dynamics, (2) therapeutic substitution toward newer PD agents, and (3) the long-standing availability of pramipexole immediate-release and other dopamine agonists that compress pricing power.

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What is MIRAPEX ER, what is it approved for, and what is the FDA regulatory status?

MIRAPEX ER is pramipexole in an extended-release oral dosage form. It is part of the dopamine agonist class used in Parkinson’s disease management. In market practice, pramipexole extended-release is positioned to reduce dosing frequency versus immediate-release pramipexole and to support adherence.

FDA pathway and labeling footprint (high-level):

• Approved drug product for Parkinson’s disease under a traditional small-molecule NDA.
• Commercial use is tied to PD symptom management, with prescribing patterns influenced by tolerability and dosing convenience.

Orange Book and exclusivity framework (high-level):

• For legacy small-molecule Parkinson’s drugs, exclusivity typically matures years before generic entry unless formulation- or use-specific patents remain listed.
• Market entry risk is determined by the expiration of listed Orange Book patents and by whether ANDA applicants submit Paragraph IV certifications to carve-out specific patents.

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What patents protect MIRAPEX ER in the U.S., and when do they expire?

Core patent estate drivers for an ER formulation product Patent coverage for MIRAPEX ER typically clusters into:

• Composition of matter (pramipexole itself and defined chemical entities or salt forms).
• Formulation patents (extended-release matrices, coatings, release profiles).
• Method-of-use patents (dosing regimens, titration schedules, patient subsets, Parkinson’s endpoints).

What this means for generic entry

• ANDA strategy usually targets the Orange Book patent set listed against the reference listed drug (RLD).
• Generic launch timing is gated by the last-to-expire patent among those listed (unless a court stays or an at-risk launch is implemented under settlement terms).

Practical market implication If MIRAPEX ER Orange Book patents are largely expired or close to expiry, pricing pressure rises quickly as generics and authorized generics appear. If formulation-specific ER patents remain in force, generic development may face formulation design-around and potential infringement risks.

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How many MIRAPEX ER Orange Book patents are listed, and which ones matter for ANDA Paragraph IV challenges?

How to interpret Orange Book lists for legacy products

• List size and patent types determine the number of likely Paragraph IV targets.
• Formulation and method-of-use patents tend to be the litigation flashpoints because they map directly to the ANDA product’s release mechanism or dosing claims.

Litigation-risk profile

• If MIRAPEX ER has multiple listed patents, the risk profile is split between infringement-of-formulation and infringement-of-method.
• If only a small subset remains, Paragraph IV challenges concentrate on those patents.

(Complete, product-specific patent listing counts and expiration dates require the exact Orange Book entries for MIRAPEX ER as currently listed; those are not provided in the prompt.)

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When does MIRAPEX ER lose exclusivity, and what generic launch scenarios exist?

Generic launch scenarios for extended-release small molecules

1. Solely patent-expiration driven entry: multiple patents expire in sequence; first ANDA approvals land after the last listed patent expiry date.
2. Carve-out settlement: an ANDA filer gets an agreed-upon launch date tied to settlement terms that may allow earlier entry for some patents but not others.
3. Paragraph IV litigation delay: trial outcomes or preliminary injunctions push launch beyond the patent expiry schedule.
4. Authorized generic (AG) structure: the brand sponsor licenses an AG partner; the market sees a brand-labeled competitive product without full loss of control.

Market projection sensitivity

• If the last listed formulation patent expires first, ER-specific generic entrants can consolidate quickly.
• If method-of-use patents remain, labeling carve-outs can delay “therapeutic substitutability” and affect uptake even after approval.

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What MIRAPEX ER clinical trials are ongoing or recently reported, and what endpoints are they using?

Clinical-trial update pattern for Parkinson’s dopamine agonists For legacy dopamine agonists, ongoing or recent studies typically fall into:

• Comparative efficacy and tolerability against other PD agents (dose optimization and switching).
• Safety and adherence studies in real-world or pragmatic designs.
• Secondary endpoints related to motor fluctuations, dyskinesia risk, and patient-reported symptom control.

Endpoints that generally drive differentiation

• Change from baseline on validated PD rating scales.
• Time to “treatment failure” or discontinuation due to adverse events.
• Adherence proxies tied to dosing convenience (extended-release vs immediate-release).
• Withdrawal rates, incidence of somnolence, edema, hallucinations, and impulse control symptoms.

(Clinical-trial identifiers, recruitment status, enrollment, and readouts are not included in the prompt; without them, a fact-accurate trial update cannot be produced.)

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How does MIRAPEX ER compare with pramipexole immediate-release and other Parkinson dopamine agonists?

Therapeutic positioning

• Extended-release formulations are often used to reduce dosing frequency and smooth pharmacokinetics.
• Immediate-release pramipexole can be dose-flexible but may require more frequent administration.

Competitive compression dynamics

• Other dopamine agonists (for example ropinirole and rotigotine) can substitute depending on dosing convenience, side-effect profile, and payer coverage.
• Newer PD pathways (including levodopa formulations and adjunct agents) can reduce incremental share for dopamine agonists in later-stage disease.

Market effect Even with stable efficacy, extended-release niche products face share erosion if:

• competing generics of immediate-release pramipexole are priced lower,
• PD regimen guidelines shift toward alternative agents for specific patient phenotypes,
• formularies prefer lower-cost agents.

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How strong is the patent estate for MIRAPEX ER, and what litigation risk does it carry?

Patent strength drivers

• Number of active Orange Book patents.
• Claim breadth of formulation and ER-release mechanism claims.
• Whether method-of-use claims cover widely used dosing/titration regimens.

Litigation risk

• Formulation infringement risk tends to be technical, centered on dissolution/release profile and excipient architecture.
• Method-of-use risk depends on ANDA labeling carve-outs and actual prescribing.
• For legacy products, litigation frequency correlates with whether at least one non-expired patent is both commercially material and actively asserted.

(Without the actual MIRAPEX ER Orange Book list and docket outcomes in the prompt, a structured strength score and litigation mapping cannot be produced.)

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What is the commercial market for pramipexole ER, and how is it trending?

Commercial market model for legacy PD agents Revenue trajectory for products like MIRAPEX ER typically depends on:

• Brand protection duration and generic penetration speed.
• Net price erosion after generic entry.
• Share drift to alternative dopamine agonists and adjunct PD therapies.
• Payer formulary placement and copay dynamics.
• Patient switching patterns, especially in elderly cohorts.

Market analysis approach (projection inputs) A defensible projection requires:

• Base-year U.S. prescription volume and net sales.
• Generic penetration timing and competitive intensity in the ER segment.
• Expected elasticity after price moves.
• Growth rate of the treated PD population under current guidelines.

Those inputs are not present in the prompt, so a numeric market forecast cannot be stated.

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Market projection: what growth, pricing, and share scenarios are most likely for MIRAPEX ER?

Scenario framework (qualitative, decision-useful)

• Base case: stable low-to-moderate decline as formularies shift toward lower-cost alternatives; modest volume sustainability due to adherence and ER convenience.
• Downside case: accelerated price erosion after generic/authorized generic entry and stronger substitution to other dopamine agonists or levodopa-based regimens.
• Upside case: limited competitive disruption if key formulation patents delay generic entry and if payers keep MIRAPEX ER on formulary due to tolerability outcomes.

A numeric forecast (with year-by-year revenues, share, and margin impact) cannot be produced without sales and market data.

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Which companies challenge MIRAPEX ER via ANDA Paragraph IV filings, and what happened in litigation?

Paragraph IV challenges depend on:

• active listed patents in the Orange Book for MIRAPEX ER,
• ANDA applicant strategy,
• and court outcomes or settlements that set launch dates.

The prompt does not provide Orange Book patent identifiers, ANDA applicant names, or litigation docket numbers, so an accurate mapping of challengers and case outcomes cannot be produced.

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What patent barriers could block a generic MIRAPEX ER entry?

Generic MIRAPEX ER development barriers typically include:

• ER mechanism design-around (matrix/coating and dissolution/release profile).
• Claim scope on release kinetics and polymer blends.
• Method-of-use label restrictions that reduce “AB-rated” substitutability.
• Potential stability, bioequivalence, and manufacturing-process sensitivities for ER release.

These barriers are real but cannot be itemized for MIRAPEX ER without the specific patent claims and compositions listed in the Orange Book.

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How does MIRAPEX ER manufacturing/IP architecture affect ability to switch formulations?

Extended-release products require:

• consistent release characteristics across batches,
• controlled manufacturing parameters,
• and tight alignment with the RLD dissolution profile.

From an IP standpoint, formulation patents often claim:

• specific excipient combinations,
• granulation methods,
• polymer particle properties,
• and release targets.

Without the patent claim set, an exact formulation design-around strategy cannot be stated.

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Key Takeaways

• MIRAPEX ER is a legacy pramipexole extended-release PD therapy whose market is shaped by long-run patent status, generic pressure, and payer formulary dynamics.
• Patent and Orange Book status determine generic timing; market projections hinge on the last-to-expire formulation or method-of-use patents and on whether Paragraph IV litigation delays entry.
• Clinical-trial updates for legacy dopamine agonists usually focus on tolerability, comparative positioning, and real-world adherence endpoints, but trial-specific facts cannot be provided from the prompt.

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FAQs

1. Does MIRAPEX ER have risks related to impulse control symptoms and hallucinations compared with dopamine agonist alternatives?
2. What matters more for generic substitution of MIRAPEX ER: Orange Book patent expiry or labeling carve-outs?
3. How do extended-release pramipexole formulations impact bioequivalence and dissolution profile requirements for ANDAs?
4. What settlement structures are most common when Paragraph IV litigation involves formulation patents for ER products?
5. How does patient-switching between dopamine agonists and levodopa-based regimens typically affect long-term ER dopamine agonist revenue?

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References

1. (No sources were provided in the prompt.)