CLINICAL TRIALS PROFILE FOR LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

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All Clinical Trials for levonordefrin; mepivacaine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00154167 ↗	Safety and Efficacy Study of NV-101 in Dental Patients	Completed	Novalar Pharmaceuticals, Inc.	Phase 2	2003-02-01	The purpose of this study was: - to determine if NV-101 accelerates recovery from numbness compared to placebo - to evaluate safety of NV-101
NCT02603198 ↗	2%-Mepivacaine With Two Different Vasoconstrictors Solutions in Third Molar Surgery a Comparative Study	Unknown status	University of Sao Paulo	N/A	2014-08-01	Dental treatments, particularly third molars extraction, can become extremely uncomfortable and painful. They are associated to anxiety, fear and many other unpleasant sensations. During surgery, patients can present cardiorespiratory repercussions of these sensations. This fact generally justifies the employment of methods of monitoring and appliance of safer therapeutic alternatives. Local anesthetics are the most frequently drugs used in dentistry. Vasoconstrictors, particularly epinephrine, are important components of anesthetic solutions to increased time for anesthetic absorption and consequently increasing the duration of anesthesia. The use of smaller amounts of anesthetic solution can reduce the risk of systemic toxicity, however decrease the total surgical time. It is well known that the amount of epinephrine injected into patients during anesthetic procedures can produce adverse hemodynamic effects. Levonordefrin was adding to dental cartridges promising to reduce cardiac stimulation due it less β activity, and maintain the same clinical and systemic effects. But some studies for maxillary or intraosseous infiltrations showed no difference in heart rate and any anesthetic success over epinephrine. Thus, this study aims to compare the clinical efficacy and safety of anesthetic mepivacaine 2% with epinephrine 1:100,000 or 1:20,000 levonordefrin employing a clinical trial model of third molars extractions in healthy adults.
NCT04617600 ↗	Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars.	Not yet recruiting	Cairo University	N/A	2021-04-01	The aim of the study is to assess the effect of TheraCal PT pulpotomy versus MTA pulpotomy on the survival rate of cariously exposed vital primary molars.
NCT05582317 ↗	Efficacy of Combination of Biodentine and Simvastatin as a Pulp Capping Materials in Vital Pulpotomy of Primary Molars	Completed	Suez Canal University	N/A	2021-05-23	Objective: This study was conducted to evaluate the efficacy of combination of biodentine with simvastatin as a pulpotomy agent for vital primary molars clinically and radiographically. Study design: 60 primary molars in 20 children aged 4-7 years old were randomly allocated to three groups, Biodentine, Simvastatin and combination of Biodentine and simvastatin. Clinical and radiographic examinations were conducted at 1, 3, 6, 9 and 12 months after treatment. Key words: Pulpotomy, Primary teeth, Biodentine, Simvastatin.

Clinical Trial Conditions for levonordefrin; mepivacaine hydrochloride

Condition Name

Condition Name for levonordefrin; mepivacaine hydrochloride
Intervention	Trials
Reversible Pulpitis	1
Soft Tissue Anesthesia (Numbness)	1
Trismus	1
Edema	1

Condition MeSH

Condition MeSH for levonordefrin; mepivacaine hydrochloride
Intervention	Trials
Pulpitis	2
Trismus	1
Hypesthesia	1

Clinical Trial Locations for levonordefrin; mepivacaine hydrochloride

Trials by Country

Trials by Country for levonordefrin; mepivacaine hydrochloride
Location	Trials
Egypt	1
Brazil	1
United States	1

Trials by US State

Trials by US State for levonordefrin; mepivacaine hydrochloride
Location	Trials
Washington	1

Clinical Trial Progress for levonordefrin; mepivacaine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for levonordefrin; mepivacaine hydrochloride
Clinical Trial Phase	Trials
Phase 2	1
N/A	3

Clinical Trial Status

Clinical Trial Status for levonordefrin; mepivacaine hydrochloride
Clinical Trial Phase	Trials
Completed	2
Unknown status	1
Not yet recruiting	1

Clinical Trial Sponsors for levonordefrin; mepivacaine hydrochloride

Sponsor Name

Sponsor Name for levonordefrin; mepivacaine hydrochloride
Sponsor	Trials
Suez Canal University	1
Novalar Pharmaceuticals, Inc.	1
University of Sao Paulo	1

Sponsor Type

Sponsor Type for levonordefrin; mepivacaine hydrochloride
Sponsor	Trials
Other	3
Industry	1

LevonoRdefrin (Levonor-d-ephrine) + Mepivacaine Hydrochloride: Clinical Trials Update, Market Analysis, and Exclusivity-Driven Forecast (2026-2036)

Last updated: July 28, 2026

How are clinical trials progressing for levonordefrin with mepivacaine hydrochloride?

Status snapshot. No complete, source-verifiable set of current (last-12-month) clinical trial records, trial results, or sponsor communications specific to the fixed combination “levonordefrin + mepivacaine hydrochloride” is available in the dataset underpinning this response, so a trial-by-trial update cannot be produced without risking factual errors.

Which trial phases are underway for this anesthetic combination?

No phase-level confirmation can be provided for this specific combination and brand-naming.

Are there recent results for block anesthesia or dental anesthesia indications?

No results set can be listed for this combination with source-verifiable dates and endpoints.

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What is the market size and growth outlook for levonordefrin plus mepivacaine?

Market framing. Levonordefrin (a sympathomimetic vasoconstrictor) plus mepivacaine (amide local anesthetic) is used to prolong anesthesia and reduce systemic absorption during local/regional anesthesia workflows. Market demand tracks procedure volumes (dental, outpatient minor surgery, and regional blocks) and substitution dynamics versus lidocaine/epinephrine, articaine/epinephrine, and prilocaine/ferroquin-like systems.

Actionable constraint: a quantified market-size model (global and by major geography) cannot be issued here because the response lacks source-verifiable revenue baselines tied to this exact drug/combination name across reporting systems.

Which route-of-administration and dosage forms drive demand?

No source-verifiable formulation/dosage-form coverage can be provided for this specific combination brand.

How does the competitive landscape differ versus lidocaine-epinephrine and articaine?

A direct, citation-backed competitive market-share comparison by combination is not possible without Orange Book / national formulary mappings for this exact active pair and brand.

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When does levonordefrin + mepivacaine lose exclusivity in the US and EU?

Exclusivity timing cannot be stated. A reliable exclusivity or patent-expiration timeline requires the specific reference product, manufacturer, and jurisdictional listings (Orange Book for US; centralized marketing authorization and patent registers for EU), plus the relevant patent families. That information is not available in the basis of this response, so any date would be non-actionable.

Are there US patents covering the combination, salts, or methods of anesthesia?

No patent estate can be listed for this combination without citation-backed identification of the relevant Orange Book listings and associated US patent numbers.

Are there EU SPCs or national patent expirations that constrain generic entry?

No EU SPC or patent-expiration constraints can be stated without the marketing authorization holder and SPC registry linkage.

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What patent estate protects levonordefrin with mepivacaine, and how strong is it?

Patent strength cannot be calculated. Patent coverage requires an identified product record with patent numbers, claims, expiration dates, and maintenance status.

What formulation patents are likely to exist (without listing assumed numbers)?

General categories include:

• Compositions including the vasoconstrictor and anesthetic in defined ratios
• Stabilizers/antioxidant systems affecting shelf-life
• Buffering systems and pH targets
• Container/packaging constraints (single-use vs multi-dose formats)

No claim set can be attributed to this specific combination without source-verified patent identifiers.

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Are there Paragraph IV challenges or generic entry risks for levonordefrin + mepivacaine?

Paragraph IV risk cannot be assessed. A list of ANDA filers, certifications, and litigation filings is not available for this exact combination within the response basis.

What would trigger early generic entry?

• Patent expiry or invalidation
• Settlement allowing “at-risk” launch or a launch date
• Loss of exclusivity tied to first approval or exclusivity-restoring events

No source-backed triggers can be mapped for this combination without the underlying listing.

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How do clinical development and regulatory pathways compare with other local anesthetic combinations?

Pathway comparison requires verified products. In general, local anesthetic combinations are developed through:

• Standard local anesthetic clinical programs (block efficacy and duration)
• Safety monitoring for sympathomimetic and systemic toxicity endpoints
• Bioequivalence requirements for generic/formulation entrants

No combination-specific pathway mapping can be completed without identifiable regulatory records for levonordefrin + mepivacaine.

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Market projection: what revenue can be expected through 2036?

Projection cannot be produced with credible anchors. A forecast needs at least one of:

• Published sales for the branded product and/or the fixed combination (national sales reports, IQVIA, company statements)
• A definable population-level procedure forecast tied to the specific formulation’s market penetration
• A bottoms-up model using unit dose and dosing frequency with confirmed package size and strength

None of these inputs are source-verifiable in the response basis, so a numeric projection would be fabricated.

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Which geographies offer the best commercial upside for this combination?

No geography ranking is possible. Without verified sales or approval/availability data for this exact combination, any geography prioritization would be speculation.

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Key Takeaways

• A source-verifiable clinical trials update for levonordefrin + mepivacaine hydrochloride cannot be produced in this response without risking inaccuracies.
• Quantified market sizing, competitor share, and 2026-2036 revenue projections cannot be issued because the response lacks source-verified baselines tied to this exact drug combination/brand.
• Exclusivity, patent expiration, Paragraph IV risk, and litigation/settlement timelines cannot be stated without identified product listings and patent families.

FAQs

1. What indications are typically targeted for levonordefrin with mepivacaine in local anesthesia products?
2. How do sympathomimetic-containing local anesthetics compare to plain mepivacaine on duration of anesthesia?
3. What endpoints are usually used in trials for local anesthetic efficacy and safety when vasoconstrictors are included?
4. How can a fixed-dose vasoconstrictor/anesthetic combination be substituted or reformulated by generics?
5. What regulatory data requirements apply when switching between dental and regional anesthesia formulations of mepivacaine-based products?

References

1. No citations were generated because the response contains no source-verifiable trial, regulatory, exclusivity, patent, or market data.