CLINICAL TRIALS PROFILE FOR LIDOCAINE HYDROCHLORIDE VISCOUS

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All Clinical Trials for LIDOCAINE HYDROCHLORIDE VISCOUS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001524 ↗	Thalidomide to Treat Oral Lesions in HIV-Infected Patients	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1996-06-01	This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day. However, PO thalidomide can cause drowsiness, skin rashes, allergic reactions, increased viral load, and even nerve damage that may not be reversible. This study will evaluate the efficacy of a topical formulation of thalidomide (placed directly on the surface of the sore) for the healing of these sores. Persons with HIV infection of acquired immunodeficiency of at least 18 years of age with one or more chronic, painful intraoral lesions may be eligible for this study. Subjects must be referred by a primary care physician who is managing their care, and must have HIV/AIDS status confirmed. Patients' HIV treatment regimen will not be altered and those receiving highly active therapy will not be excluded. Patients will be excluded if they are concurrently being treated for mucosal lesions (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals, or mouthwashes), or concurrent thalidomide therapy; receving chemotherapy or radiation therapy for neoplasms; using concurrent acute therapy for opportunistic infections; concurrent use of sedatives (such as CNS depressants or alcohol use); history of allergy to thalidomide; pre-existing peripheral neuropathy of grade II or higher; pregnant or lactating females or those not practicing contraception according to FDA guidelines for thalidomide.
NCT01087489 ↗	Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye	Completed	Bascom Palmer Eye Institute	N/A	2010-04-01	Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.
NCT01087489 ↗	Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye	Completed	University of Miami	N/A	2010-04-01	Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.
NCT01087489 ↗	Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye	Completed	Miami VA Healthcare System	N/A	2010-04-01	Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.
NCT01612156 ↗	Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics	Completed	University of Southern California	N/A	2011-12-01	The purpose of this study is to determine a difference in patient reported pain levels before, during, and after multichannel urodynamics in patients treated with 2% lidocaine gel or water based lubricant. We hypothesize that lidocaine gel will decrease pain levels when compared to lubricant gel.
NCT01640171 ↗	Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival	Completed	Retina Vitreous Associates of Florida	N/A	2012-07-01	Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema are being administered in the United States at increasing rates. A 2010 study showed that in Canada and the incidence of injections grew 8 fold from 2005 to 2007 to 25.9 injections per 100,000 citizens. (Campbell 2010) In 2009, in the United States, over 1 million intravitreal injections were administered to Medicare beneficiaries. (Wykoff 2011) In the year 2011, the four doctors in my retina group administered a total of 6,494 intravitreal injections; in 2010, we administered 5021 intravitreal injections. Even though intravitreal injections are commonly administered, the optimal method of anesthetizing the eye prior to injection has yet to be determined. Some physicians use an anesthetic drop, some a soaked cotton pledget, some use an anesthetic gel and some use subconjunctival injected anesthetic. In 2009, the last time the Procedures and Trends Survey (PAT) (Mittra 2009) conducted by the American Society of Retina Specialists (the largest retina society in the world) asked about anesthetic methods for administering intravitreal injections, the following response was given by the 433 respondents: - Topical anesthetic drop: 21.48% - Topical viscous anesthetic: 23.33% - Topical anesthetic & soaked cotton-tip or pledget: 29.79% - Subconjunctival injection of anesthetic: 24.02% - Other: 1.39% An editorial in 2011 in the journal Retina, discusses the lack of good studies assessing optimal anesthetic prior to intravitreal injections. (Prenner 2011).
NCT01898728 ↗	Comparison of the Effectiveness of Povidone-iodine in Reducing Conjunctival Bacterial Load Prior to Cataract Surgery in Patients Treated With a Lidocaine Gel Dilating Formulation Versus Eye Drops: A Randomized Controlled Trial	Completed	McMaster University	N/A	2012-12-01	The eye contains a lens that focuses light. A clouding of the lens is known as a cataract. Cataracts decrease vision. The treatment for cataracts is cataract surgery. Cataract surgery is one of the most commonly performed surgical procedures. Although rare, complications of cataract surgery are significant given the number of people who have surgery each year and more serious complications may have a significant impact on the vision and quality of patients. Endophthalmitis is an infection in the eye and it is one of the worst complications of cataract surgery. Most of these infections are caused by bacteria from the patient's skin and conjunctiva, which makes cleaning the skin and eye before surgery very important. Before cataract surgery, patients receive an umber of eye drops; many surgical centers have a combination of medications in a thick gel, so that the medications remain in the eye for a long period of time, which may improve their effect. Laboratory studies suggest that the antibacterial effect of cleaning solutions may be inhibited by gels but this has not been proven, and many believe it to be untrue. This study is to compare the amount of bacteria on the eye prior to surgery in patients receiving a gel formulation of the medications before surgery as compared to those receiving the same medication in eye drop (liquid) form.

Clinical Trial Conditions for LIDOCAINE HYDROCHLORIDE VISCOUS

Condition Name

Condition Name for LIDOCAINE HYDROCHLORIDE VISCOUS
Intervention	Trials
Pain	2
Airway Responses	1
HIV Infection	1
Anesthetics, Local	1

Condition MeSH

Condition MeSH for LIDOCAINE HYDROCHLORIDE VISCOUS
Intervention	Trials
Urinary Bladder, Overactive	2
Syndrome	2
Cataract	1
Esophageal Achalasia	1

Clinical Trial Locations for LIDOCAINE HYDROCHLORIDE VISCOUS

Trials by Country

Trials by Country for LIDOCAINE HYDROCHLORIDE VISCOUS
Location	Trials
United States	9
Canada	3
Belgium	1
Denmark	1
Egypt	1

Trials by US State

Trials by US State for LIDOCAINE HYDROCHLORIDE VISCOUS
Location	Trials
Maryland	3
California	2
Florida	2
Utah	1
New York	1

Clinical Trial Progress for LIDOCAINE HYDROCHLORIDE VISCOUS

Clinical Trial Phase

Clinical Trial Phase for LIDOCAINE HYDROCHLORIDE VISCOUS
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	3
Phase 3	1

Clinical Trial Status

Clinical Trial Status for LIDOCAINE HYDROCHLORIDE VISCOUS
Clinical Trial Phase	Trials
Completed	9
Recruiting	4
Enrolling by invitation	2

Clinical Trial Sponsors for LIDOCAINE HYDROCHLORIDE VISCOUS

Sponsor Name

Sponsor Name for LIDOCAINE HYDROCHLORIDE VISCOUS
Sponsor	Trials
Walter Reed National Military Medical Center	2
National Cancer Institute, Egypt	1
Stanford University	1

Sponsor Type

Sponsor Type for LIDOCAINE HYDROCHLORIDE VISCOUS
Sponsor	Trials
Other	19
U.S. Fed	2
FED	1

Last updated: July 28, 2026

Lidocaine Hydrochloride Viscous clinical trials update, market outlook, and projection

Lidocaine hydrochloride viscous is an off-patent, locally acting anesthetic formulation used for oral mucosal pain (eg, sore mouth, canker sores, dental pain) and related symptomatic indications. Public clinical-trials activity is limited and largely uninformative for exclusivity timing. Market value is driven by generic availability, channel mix (retail vs clinic), and substitution at the pharmacy level rather than by brand-level patent leverage.

No complete, citation-grounded dataset for a single, specific “lidocaine hydrochloride viscous” product line (including FDA NDA/BLA linkage, Orange Book listing, or a consolidated clinical trials set tied to one sponsor) is available in the provided context to support an accurate trial-by-trial update, jurisdictional patent map, or forecast with quantified figures.

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What clinical trials are running for lidocaine hydrochloride viscous right now?

Featured snippet answer: There is no consolidated, product-specific, sponsor-attributed public trials package available here that can be reported as “running right now” for lidocaine hydrochloride viscous as a single asset class.

What trials typically exist for this drug class

Most publicly observable efforts for viscous oral lidocaine tend to be:

• Formulation performance work (viscosity, taste masking, mucoadhesion, residence time)
• Bioequivalence studies for generic equivalents where endpoints are systemic absorption
• Dental/oral surgery symptom management studies using lidocaine-containing topical regimens

Why a “viscous lidocaine” trials update is hard to pin down

Clinical trial records often target:

• A combination product (lidocaine plus an antiseptic or anti-inflammatory)
• A device or procedural protocol (dental procedures, endoscopy, burn/ulcer pain) rather than “viscous” as a standalone formulation
• Different dosage forms (spray, gel, solution) under a broader “topical lidocaine” umbrella

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How big is the market for lidocaine hydrochloride viscous, and what drives demand?

Featured snippet answer: Demand tracks symptomatic use of oral anesthetics and oral pain management, with purchasing driven by generics, payer/plan formularies, and substitution at dispensing.

Key demand drivers

1. Chronic vs episodic use patterns

   • Episodic: aphthous ulcers, dental pain episodes
   • Low persistence: patients usually use short courses

2. Switching behavior

   • Oral topical anesthetics are easy to substitute by strength, volume, and organoleptic profile.
   • Viscous formats face competitive pressure from gels, swishes, and lozenges.

3. Care setting

   • Retail: over-the-counter and physician-script overlap
   • Dental and urgent care: procedural pain and post-procedure symptoms

Competitive structure

• The competitive set is dominated by multi-source generic products and pharmacy equivalents.
• Brand differentiation is mostly sensory (taste, mouthfeel), packaging, and dosing convenience, not IP.

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When does lidocaine hydrochloride viscous lose exclusivity, and what does that mean for launches?

Featured snippet answer: Lidocaine hydrochloride viscous is treated by the market as off-patent, so exclusivity-driven timing is not a material gating factor for new entry; entry is mainly governed by generic regulatory readiness and supply.

Practical exclusivity implications

• New entrants generally rely on abbreviated regulatory pathways and generic bioequivalence or product sameness.
• Differentiation is limited; so pricing typically compresses as supply expands.

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What is the FDA and Orange Book status of lidocaine hydrochloride viscous?

Featured snippet answer: The asset is generally regarded as off-patent and widely marketed in generic form, but product-specific Orange Book status cannot be confirmed in this context without a linked NDA/application identifier.

How status affects forecasting

• If a specific product is not protected by unexpired listed patents, forecast variance is driven by generic competitive intensity and inventory cycles rather than patent expiry.
• If any listed patents exist for particular strengths or specific dosage forms, timing could still influence a subset of SKUs. That cannot be stated accurately without verified listings.

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What patent estate protects viscous lidocaine, and how strong is it?

Featured snippet answer: The drug class is broadly off-patent; any remaining protection is most likely limited to minor formulation, manufacturing, or method-of-use claims tied to specific branded or specific generic manufacturing processes, not to the active ingredient itself.

Where “last-mile” IP can still matter

Even when active ingredient patents have lapsed, remaining risk can come from:

• Composition of matter for a specific viscous vehicle system
• Taste-masking or mucoadhesive excipient combinations
• Manufacturing process claims
• Method-of-use claims tied to procedural protocols

A quantified count of patents, their jurisdictions, and their expiration dates cannot be provided here without verifiable patent identifiers tied to specific marketed products.

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Which companies market lidocaine hydrochloride viscous, and what does that imply for pricing?

Featured snippet answer: The market is structurally generic, with multiple manufacturers. Pricing typically trends toward the lowest-cost compliant supply.

Pricing and volume mechanics

• Wholesale acquisition cost is pressured by competitive supply.
• Retail price depends on pharmacy benefit design, co-pay, and substitution rules.
• Margin opportunities often appear in:
  • Niche strengths/volumes
  • Clinic supply contracts
  • Private-label or contract manufacturing agreements

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How does lidocaine hydrochloride viscous compare with lidocaine gel, spray, and lozenges in substitution risk?

Featured snippet answer: Substitution risk is high across topical lidocaine formats; viscous products compete with gel and spray more directly than with systemic lidocaine.

Substitution levers

• Patient preference: taste, mouthfeel, ease of application
• Clinician workflow: procedural speed and dosing accuracy
• Adherence: viscous retention may be preferred for short-term ulcer pain, while sprays can be more convenient

Market impact on projections

Forecasts for viscous products should model share pressure from:

• More “user-friendly” formats
• Combination products that add antiseptic or anti-inflammatory components
• Insurance-driven formulary steering

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What generic entry risks exist for lidocaine hydrochloride viscous?

Featured snippet answer: Generic entry risk is mainly manufacturing and regulatory compliance, not patent-driven delay.

What can still create barriers

• Quality system capability for viscous formulations
• Stability shelf-life and container-closure requirements
• Taste and sensory consistency that impacts acceptance and switching

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What settlement agreements or Paragraph IV litigation affects lidocaine hydrochloride viscous?

Featured snippet answer: No litigation or settlement record can be reliably assigned to “lidocaine hydrochloride viscous” as a single, product-specific case without a verified Orange Book listing or linked NDA/app number in this context.

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Commercial projection: base case, bull case, bear case for lidocaine hydrochloride viscous (market share and revenue)

Featured snippet answer: Because the product is largely generic and off-patent, projections should be driven by generic competitive intensity and volume growth from oral pain demand, not by launch of a new protected competitor.

Projection framework (what typically moves the line)

1. Unit volume

   • Oral pain incidence and dental procedure volumes
   • Seasonal variation for minor oral lesions and dental visit patterns

2. Net price

   • Competitive intensity among generics
   • PBM and wholesaler contract changes

3. Mix

   • Viscous vs gel vs spray mix shift
   • Strength/volume mix within viscous SKUs

What this projection cannot state here

• Numerical market size, growth rate (CAGR), or manufacturer-by-manufacturer revenue splits cannot be provided without sourced market data.
• SKU-level revenue forecasts also require verified product identifiers.

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Key Takeaways

• Lidocaine hydrochloride viscous is a generic, off-patent oral topical anesthetic with demand tied to symptomatic oral pain and dental/clinic utilization.
• Patent-driven exclusivity timing and Paragraph IV litigation are not primary forecast drivers for this drug class.
• Clinical trials updates are unlikely to be product-defining; most activity is formulation performance or bioequivalence rather than innovation.
• Market projections are most sensitive to generic competitive intensity, substitution across lidocaine dosage forms, and pharmacy/clinic channel mix.

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FAQs

1. Is lidocaine hydrochloride viscous available over the counter, and does that affect demand forecasts?
2. Do formulation differences (viscosity, excipients, alcohol content) change clinical outcomes or switching patterns?
3. How do PBM formularies typically classify topical oral anesthetics like viscous lidocaine versus gels and sprays?
4. What stability and container-closure factors matter most for viscous lidocaine product quality and supply reliability?
5. How should a generic entrant price viscous lidocaine to win share against established multi-source competitors?

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References

No sources were provided in the prompt for clinical trials, FDA status, Orange Book listings, patents, or market data.