CLINICAL TRIALS PROFILE FOR LODOSYN

All Clinical Trials for LODOSYN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00547911 ↗	Augmenting Effects of L-DOPS With Carbidopa and Entacapone	Terminated	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1/Phase 2	2007-10-01	An experimental drug called L-DOPS increases production in the body of a messenger chemical called norepinephrine. Cells in the brain that make norepinephrine are often gone in Parkinson disease. The exact consequences of this loss are unknown, but they may be related to symptoms such as fatigue, depression, or decreased attention that occur commonly in Parkinson disease. This study will explore effects of L-DOPS in conjunction with carbidopa and entacapone, which are drugs used to treat Parkinson disease. We wish to find out what the effects are of increasing norepinephrine production in the brain and whether carbidopa and entacapone augment those effects. Volunteers for this study must be at least 18 years of age and able to give consent to participate in the study. To participate in the study, volunteers must discontinue use of alcohol, tobacco, and certain herbal medicines or dietary supplements, and must also taper or discontinue certain kinds of medications that might interfere with the results of the study. Candidates will be screened with a medical history and physical exam. Participants will be admitted to the National Institutes of Health Clinical Center for two weeks of testing. The study will have three testing phases in a randomly chosen order for each participant: - Single dose of L-DOPS - Single dose of L-DOPS in conjunction with carbidopa - Single dose of L-DOPS in conjunction with entacapone Each phase will last two days, with a washout day between each phase in which no drugs will be given and no testing will be performed. In each phase, participants will undergo a series of tests and measurements, including blood pressure and electrocardiogram tests. Participants who are healthy volunteers will also have blood drawn and will undergo a lumbar puncture (also known as a spinal tap) to obtain spinal fluid for chemical tests.
NCT00581477 ↗	Treatment of Orthostatic Hypotension	Completed	Vanderbilt University	Phase 3	2004-01-01	The purpose of this study is to try different medications in patients with low blood pressure and other problems with their involuntary (autonomic) nervous system. The pharmacological trials in this study will perhaps lead to more effective treatment. This study consists of single dose trials, dose selection trials, 5-day trials and chronic (approximately 2 months) trials.
NCT00581477 ↗	Treatment of Orthostatic Hypotension	Completed	Vanderbilt University Medical Center	Phase 3	2004-01-01	The purpose of this study is to try different medications in patients with low blood pressure and other problems with their involuntary (autonomic) nervous system. The pharmacological trials in this study will perhaps lead to more effective treatment. This study consists of single dose trials, dose selection trials, 5-day trials and chronic (approximately 2 months) trials.
NCT00914602 ↗	An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects	Completed	XenoPort, Inc.	Phase 1/Phase 2	2009-05-01	The purpose of the study is to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation [administered with Lodosyn® (carbidopa)] and Sinemet® tablets in subjects with Parkinson's disease with Motor Fluctuations.

Clinical Trial Conditions for LODOSYN

Condition Name

Condition Name for LODOSYN
Intervention	Trials
Multiple System Atrophy	2
Autonomic Nervous System Diseases	2
Parkinson Disease	2
Multiple Sclerosis	2

Condition MeSH

Condition MeSH for LODOSYN
Intervention	Trials
Autonomic Nervous System Diseases	4
Primary Dysautonomias	4
Parkinson Disease	3
Dysautonomia, Familial	2

Clinical Trial Locations for LODOSYN

Trials by Country

Trials by Country for LODOSYN
Location	Trials
United States	9
United Kingdom	1

Trials by US State

Trials by US State for LODOSYN
Location	Trials
Tennessee	3
Florida	2
Maryland	1
New York	1
Michigan	1

Clinical Trial Progress for LODOSYN

Clinical Trial Phase

Clinical Trial Phase for LODOSYN
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	3
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for LODOSYN
Clinical Trial Phase	Trials
Completed	7
Recruiting	1
Terminated	1

Clinical Trial Sponsors for LODOSYN

Sponsor Name

Sponsor Name for LODOSYN
Sponsor	Trials
Vanderbilt University	2
Vanderbilt University Medical Center	2
New York University School of Medicine	2

Sponsor Type

Sponsor Type for LODOSYN
Sponsor	Trials
Other	11
Industry	2
NIH	1

LODOSYN (levodopa) clinical trials update, market analysis, and exclusivity-to-generic projection

Last updated: August 1, 2026

Executive summary

• LODOSYN (carbidopa/levodopa combination brand) market access and clinical-trial visibility remain limited in the US compared with newer levodopa delivery systems and alternative Parkinson’s regimens.
• Competitive risk is driven by pharmacy switching, payer substitution, and generic penetration rather than breakthrough clinical development.
• Near- to mid-term demand is projected to be stable-to-moderate because levodopa is long-established for Parkinson’s disease, while new starts increasingly use newer branded or combination formulations when available and covered.
• The main forward-looking variables for LODOSYN’s US revenue trajectory are: (1) generic price compression, (2) any remaining formulation-specific exclusivity, and (3) the share of patients who remain on legacy levodopa regimens.

What is LODOSYN and what active ingredient does it contain?

LODOSYN is the trade name used for a levodopa product in the Parkinson’s disease space. Levodopa is the cornerstone dopaminergic therapy; product-level differentiation typically comes from formulation (immediate vs controlled release), combination partners, and bioavailability characteristics.

Which drug class does LODOSYN belong to?

• Parkinson’s disease: dopaminergic agent
• Core pharmacology: levodopa → dopamine in the CNS

What dosage forms and strengths are typically marketed?

Levodope legacy brands commonly include oral tablets and vary by strength. The exact US marketed strengths and dosage forms materially affect formulary access and switching patterns.

What clinical trials have been reported for LODOSYN?

A clinically meaningful “trial update” requires two things: (1) a specific US/NCT listing or published protocol for LODOSYN (not just levodopa broadly), and (2) current status (recruiting, active, completed) with endpoints (UPDRS, motor complications, time to wearing off, dyskinesia, etc.).

No LODOSYN-specific trial registry linkage is provided in the source material available in this chat, so a complete and accurate trial update cannot be produced.

Is LODOSYN still being studied or does it have new indications?

LODOSYN’s clinical footprint is expected to be dominated by levodopa use in Parkinson’s disease rather than brand-specific innovation, unless there is a formulation-specific program (controlled release, bioequivalence strategy, or patient-specific dosing).

A complete, accurate “new indications” answer for LODOSYN requires brand-labeled development programs and filings. That information is not present in the available inputs.

What is the Orange Book status of LODOSYN (US exclusivity and listed patents)?

Orange Book status is required to map:

• listed patents by type (drug substance, drug product, method-of-use),
• expiration and pediatric exclusivity,
• any listed exclusivity blocks (NCE/505(b)(2) exclusivity),
• and potential entry triggers.

No Orange Book patent listing identifiers, expiration dates, or exclusivity blocks for LODOSYN are provided here. Without those listings, exclusivity timelines cannot be stated accurately.

When does LODOSYN lose exclusivity and what is the patent expiration schedule?

A reliable projection depends on:

• earliest non-patent exclusivity date (if any),
• earliest listed patent expiration for the relevant FDA application,
• and any life-cycle extensions (formulation, polymorph, salts, process, method-of-use).

No patent expiration schedule for LODOSYN is included in the available material.

How many patents protect LODOSYN and which patent holders own the estate?

A market-and-litigation projection must quantify:

• number of Orange Book-listed patents,
• family breadth (continuations, divisional filings),
• assignees (brand owner vs licensors),
• and jurisdictions.

That estate structure is not available in the information provided in this chat.

What formulations are protected by LODOSYN patents (immediate vs controlled release)?

Formulation IP matters because it drives generic entry sequencing:

• bioavailability-related claims,
• release profile claims,
• excipient/process-defined product claims.

No LODOSYN formulation patent list is available here.

What generic entry risks exist for LODOSYN (Paragraph IV filings)?

A Paragraph IV-driven risk assessment requires:

• FDA Paragraph IV notices (generic applicant identity),
• asserted Orange Book patents,
• and settlement status timelines.

No Paragraph IV filing record is included in the provided inputs, so risks cannot be stated precisely.

What patent litigation affects LODOSYN and what settlements are in place?

Patent litigation and any 30/40-month stay impact generic timing and revenue. A structured answer requires:

• case captions,
• court (D. Del., S.D.N.Y., etc.),
• filing dates and outcome,
• settlements and effective dates.

No LODOSYN litigation data is available in the supplied information.

What is the FDA regulatory status of LODOSYN (NDA vs ANDA vs 505(b)(2))?

FDA regulatory mapping requires:

• application type,
• reference product,
• label and bioequivalence basis,
• current approval supplements.

No FDA application identifiers for LODOSYN are provided here.

LODOSYN market analysis: who buys it, where is it sold, and what drives revenue?

For legacy Parkinson’s therapies, revenue drivers typically include:

• formulary positioning (tier placement, restrictions, prior authorization),
• channel mix (retail vs mail order),
• WAC-to-net discounts and rebate pressures,
• generic substitution after patent/payer triggers,
• and patient adherence tied to dosing convenience and symptom control.

However, a quantified market analysis requires:

• current sales (US net sales, prescription units, pharmacy claims),
• payer and channel breakdown,
• competitor share,
• and historical trends.

Those metrics are not included in the available material in this chat, so a full market analysis with hard numbers cannot be produced.

LODOSYN competitive landscape: how does it compare with other levodopa brands and generics?

Without a defined LODOSYN label (e.g., combination partner, ER vs IR, strengths) and without competitor SKU mapping, an accurate competitive comparison cannot be stated.

At a high level, the competitive set in Parkinson’s disease includes:

• levodopa generics (price-driven),
• branded levodopa combination products where covered,
• device-assisted and alternative strategies in later-stage disease.

But “which ones matter” and how LODOSYN performs relative to them requires product-level inputs.

What is the clinical and commercial outlook for LODOSYN over the next 3 to 5 years?

A 3–5 year projection must connect exclusivity and entry timing to:

• expected generic launch date,
• expected number of ANDAs,
• price erosion curve,
• and utilization trend (incident prevalence and switching).

No exclusivity date, no generic launch indicator, and no sales baseline are provided in this chat, so a complete projection cannot be generated accurately.

How should investors and licensors model LODOSYN revenue under generic erosion scenarios?

A defensible scenario model requires at least:

• baseline US sales or unit volume,
• expected generic launch and timeline,
• number of entrants,
• and payer dynamics.

Those inputs are not present here.

Key Takeaways

• A complete and accurate clinical trials update for LODOSYN requires LODOSYN-specific registries or publications; no such trial identifiers are present in the provided material.
• A rigorous exclusivity and patent-to-generic projection requires Orange Book patent and exclusivity listings; those details are not provided here.
• A quantified market analysis and revenue forecast requires current sales/units and competitor SKU mapping; neither is available in the provided material.
• The actionable framework for future work is clear: map Orange Book patents and any Paragraph IV litigation to expected generic entry and then link entry to price and utilization trends. That mapping cannot be completed from the inputs available in this chat.

FAQs

1. What Orange Book patents are listed for LODOSYN and when do they expire?
2. Have any generic applicants filed Paragraph IV challenges against LODOSYN’s listed patents?
3. Are there LODOSYN-specific clinical trials registered under NCT numbers, and what are their outcomes?
4. What are the main payer and formulary factors that determine whether LODOSYN is substituted for generics?
5. How can a generic entry scenario be modeled for LODOSYN if the earliest patent or exclusivity date is known?

References

No sources were provided in the prompt content of this chat.