CLINICAL TRIALS PROFILE FOR PARCOPA

All Clinical Trials for PARCOPA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00139867 ↗	A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease	Completed	UCB Pharma	Phase 3	2004-01-01	The objective of this trial was to assess subject preference for PARCOPA, carbidopa/levodopa Orally Disintegrating Tablets (ODT), compared with conventional carbidopa/levodopa tablets, in subjects with stable Parkinson's disease.
NCT00139880 ↗	A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease	Completed	UCB Pharma	Phase 3	2005-06-01	To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are eligible if taking a stable dose of < 200 mg carbidopa and < 2000 mg levodopa daily. At both treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or conventional) are administered. The dose is the same as the subject's prestudy regimen. The primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by a rater blinded to the active treatment received by the subject.
NCT00590122 ↗	Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study	Completed	UCB Pharma	Phase 4	2006-10-01	To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
NCT00590122 ↗	Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study	Completed	Baylor College of Medicine	Phase 4	2006-10-01	To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
NCT01663935 ↗	Vision Response to Dopamine Replacement	Terminated	University of Wisconsin, Madison	Phase 2	2012-10-17	The purpose of the study is to evaluate and document physiologic and functional changes in visual performance and retinal function of patients diagnosed with albinism (a dopamine deficiency state) following a trial of oral Levodopa/carbidopa treatment.

Clinical Trial Conditions for PARCOPA

Condition Name

Condition Name for PARCOPA
Intervention	Trials
Parkinson's Disease	3
Toe Fusion	1
Acute Pain	1
Albinism	1

Condition MeSH

Condition MeSH for PARCOPA
Intervention	Trials
Parkinson Disease	3
Pain, Postoperative	1
Acute Pain	1
Cocaine-Related Disorders	1

Clinical Trial Locations for PARCOPA

Trials by Country

Trials by Country for PARCOPA
Location	Trials
United States	6

Trials by US State

Trials by US State for PARCOPA
Location	Trials
Wisconsin	3
Illinois	1
Virginia	1
Texas	1

Clinical Trial Progress for PARCOPA

Clinical Trial Phase

Clinical Trial Phase for PARCOPA
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for PARCOPA
Clinical Trial Phase	Trials
Completed	4
Terminated	1
Not yet recruiting	1

Clinical Trial Sponsors for PARCOPA

Sponsor Name

Sponsor Name for PARCOPA
Sponsor	Trials
UCB Pharma	3
Baylor College of Medicine	1
University of Wisconsin, Madison	1

Sponsor Type

Sponsor Type for PARCOPA
Sponsor	Trials
Other	5
Industry	3
NIH	2

Parcopa (carbidopa/levodopa ODT) clinical trials update, market analysis, and exclusivity outlook

Last updated: July 28, 2026

Parcopa is a brand of carbidopa/levodopa orally disintegrating tablets (ODT) for Parkinson’s disease. Public clinical-trial and IP exclusivity updates are not sufficiently specified in the input to produce an accurate, date-stamped update, a verified Phase-level trial pipeline, or a defensible market forecast tied to current launches and payer dynamics.

What is Parcopa (carbidopa levodopa ODT) and how is it used in Parkinson’s disease?

Parcopa is indicated for the treatment of Parkinson’s disease. The drug combines:

• Levodopa, a dopamine precursor
• Carbidopa, a peripheral dopa-decarboxylase inhibitor that reduces peripheral metabolism of levodopa and increases levodopa bioavailability

Key differentiator vs immediate-release carbidopa/levodopa tablets

• Orally disintegrating tablet (ODT) format designed to improve dosing convenience for patients with swallowing difficulty
• Formulation-level IP typically focuses on the ODT composition, excipients, and manufacturing parameters rather than the active ingredients

What strengths and dosing forms are associated with Parcopa?

This cannot be completed from the provided input.

What clinical trials are currently evaluating Parcopa and what is their status?

This cannot be produced from the provided input. A complete update requires trial-by-trial identification (NCT numbers), phase, enrollment status, endpoints, and posting dates.

How large is the Parcopa market and who drives demand by geography and channel?

This cannot be produced from the provided input. A defensible market analysis requires:

• Current sales and trend data
• Channel mix (institutional vs retail, mail order)
• Geography-specific prescribing and substitution patterns
• Net pricing and payer formulary position
• Segment demand tied to ODT-specific patient adherence or intolerance drivers

How does Parcopa compete with generic carbidopa/levodopa and ODT alternatives?

This cannot be produced from the provided input. A proper comparison needs:

• Labeled strengths and interchangeability
• FDA Orange Book substitution landscape for ODT vs conventional tablets
• Pricing dispersion and PBM contracting
• Brand retention drivers such as intolerance, formulary exclusions, and procurement rules

When does Parcopa lose exclusivity and what patents or exclusivity mechanisms matter?

This cannot be produced from the provided input. A correct exclusivity and patent-expiration view requires:

• Parcopa-specific Orange Book listing extraction (application number, listed patents, expiration)
• Patent family mapping to the ODT formulation and manufacturing
• Any FDA exclusivity (market exclusivity, pediatric exclusivity) tied to the specific NDA/supplement

What is the Orange Book status of Parcopa (listed patents, expiration dates, and regulatory codes)?

This cannot be produced from the provided input. An Orange Book status section requires direct, listing-level data:

• Drug product and active ingredient identifiers
• Patent numbers, patent types (drug substance, drug product, method of use, formulation)
• Expiration dates and any pediatric PRV-related extensions
• Application type (NDA vs ANDA references) and reporting categories

Are there Paragraph IV challenges against Parcopa and what settlements changed launch timing?

This cannot be produced from the provided input. A Paragraph IV section must be based on:

• Listing-based ANDA certifications (Paragraph IV, I, II, III)
• Court dockets or complaint dates
• Settlement announcement dates and terms affecting launch timing

What generics or biosimilar-type risks exist for Parcopa?

Parcopa is a small-molecule drug, so “biosimilar” is not the right category. Generic substitution risk is the relevant issue, but the question cannot be answered without verified Orange Book certifications and the ANDA/launch activity tied to the specific Parcopa listing.

How does Parcopa compare clinically and commercially with other dopamine precursor regimens?

This cannot be produced from the provided input. A comparative analysis requires:

• Published head-to-head or bioavailability evidence
• Real-world endpoints (adherence, dysphagia-related discontinuation, caregiver administration burden)
• Market share comparisons across comparable PD regimens

Market projection for Parcopa: what is the base case, bull case, and bear case scenario?

This cannot be produced from the provided input. A forecast must quantify drivers including:

• Net sales trend and elasticity to generic entry
• ODT share dynamics
• Competitive contracting and rebate pressure
• Patient population growth and PD incidence trends
• Regulatory and patent milestones that drive substitution waves

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Key Takeaways

• Parcopa is an ODT formulation of carbidopa/levodopa for Parkinson’s disease.
• The provided input does not contain enough drug-specific trial, Orange Book, patent, litigation, or sales data to generate a verified clinical-trials update, exclusivity/patent timeline, or market projection.

FAQs

1. What FDA pathway (NDA supplement type) is used for Parcopa ODT changes, and how does that affect exclusivity?
2. How do ODT carbidopa/levodopa formulations differ in bioavailability and dissolution across generic equivalents?
3. What are the most common adverse events and adherence barriers that make ODT dosing relevant in real-world Parkinson’s care?
4. What is the safest way to map Parcopa’s listed patents to formulation IP and manufacturing process claims for litigation risk?
5. How should a forecast model incorporate PBM formulary tiering and rebate erosion for branded ODT products in Parkinson’s disease?

References (APA)

No sources were provided in the input.