CLINICAL TRIALS PROFILE FOR LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

All Clinical Trials for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001724 ↗	Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1997-11-01	This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
NCT00107822 ↗	Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Children	Completed	ZARS Pharma Inc.	Phase 3	2005-04-01	The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in children. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.
NCT00107835 ↗	Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Adults	Completed	ZARS Pharma Inc.	Phase 3	2005-05-01	The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in adults. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.
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
NCT00194610 ↗	Botox as a Treatment for Interstitial Cystitis in Women	Completed	Paul G. Allen Family Foundation	Phase 4	2004-05-01	Patients with interstitial cystitis have been well documented to have pelvic floor muscle tenderness as well as pain on bladder distension. Some investigators have even suggested that pelvic floor muscle pain is primarily the cause of bladder problems. Botulinum toxin A causes muscle relaxation by inhibiting the acetylcholine release at the neuromuscular junction. It has been shown that this mechanism relieves pain in a number of muscle spasm-related syndromes. Because, at present, there is little effective therapy available for patients with interstitial cystitis, the researchers want to determine if botulinum toxin A will relieve bladder and pelvic pain in these patients.
NCT00194610 ↗	Botox as a Treatment for Interstitial Cystitis in Women	Completed	University of Washington	Phase 4	2004-05-01	Patients with interstitial cystitis have been well documented to have pelvic floor muscle tenderness as well as pain on bladder distension. Some investigators have even suggested that pelvic floor muscle pain is primarily the cause of bladder problems. Botulinum toxin A causes muscle relaxation by inhibiting the acetylcholine release at the neuromuscular junction. It has been shown that this mechanism relieves pain in a number of muscle spasm-related syndromes. Because, at present, there is little effective therapy available for patients with interstitial cystitis, the researchers want to determine if botulinum toxin A will relieve bladder and pelvic pain in these patients.
NCT00300092 ↗	Pediatric Fingertip Injuries:Are Antibiotics Required?	Completed	Children's Hospital Los Angeles	Phase 2	2000-09-01	Study objective: Fingertip injuries are common in the pediatric population. Considerable controversy exists about whether prophylactic antibiotics are necessary after repair of such injuries. Our goals were to estimate the rate of bacterial infection among pediatric patients with distal fingertip injuries overall and to compare the rate of bacterial infections among subgroups treated with and without prophylactic antibiotics. Methods: This was prospective randomized control study of pediatric patients presenting to an urban children's hospital with trauma to the distal fingertip requiring repair. Patients were randomized to two groups: those receiving prophylactic antibiotics (Cephalexin) and those who did not receive antibiotic therapy. Repairs were performed in a standardized fashion and all patients were re-evaluated in the same emergency department in 48 hours and by phone 7 days later. The primary outcome of this study was the incidence of infection.

Clinical Trial Conditions for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Condition Name

Condition Name for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
Intervention	Trials
Pain	25
Anesthesia, Local	14
Pain, Postoperative	12
Postoperative Pain	10

Condition MeSH

Condition MeSH for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
Intervention	Trials
Pain, Postoperative	35
Pulpitis	26
Acute Pain	12
Lacerations	8

Clinical Trial Locations for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Trials by Country

Trials by Country for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
Location	Trials
United States	130
Canada	18
Egypt	11
Saudi Arabia	8
Pakistan	7

Trials by US State

Trials by US State for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
Location	Trials
California	27
New York	12
Pennsylvania	10
North Carolina	7
Ohio	7

Clinical Trial Progress for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Clinical Trial Phase

Clinical Trial Phase for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
Clinical Trial Phase	Trials
PHASE4	11
PHASE3	5
PHASE2	5

Clinical Trial Status

Clinical Trial Status for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
Clinical Trial Phase	Trials
Completed	143
RECRUITING	35
Not yet recruiting	27

Clinical Trial Sponsors for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Sponsor Name

Sponsor Name for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
Sponsor	Trials
University of California, San Diego	7
University of North Carolina, Chapel Hill	5
University of Minnesota	5

Sponsor Type

Sponsor Type for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
Sponsor	Trials
Other	296
Industry	29
U.S. Fed	8

Last updated: July 28, 2026

Lidocaine Hydrochloride and Epinephrine Clinical Trials Update, Market Analysis, and Forecast (2026-2036)

Lidocaine hydrochloride plus epinephrine is a widely used local anesthetic/vasoconstrictor combination for procedures requiring local anesthesia and reduced bleeding. The product category is mature, largely off-patent in most markets, with competition dominated by generics, authorized label variants, and alternate local anesthetics. Near-term market growth is driven by procedure volume in dentistry, minor surgery, dermatology, and emergency/urgent care settings, plus substitution patterns within local anesthetic portfolios rather than new-molecule breakthroughs.

What clinical trials are evaluating lidocaine hydrochloride and epinephrine in 2026?

No molecule-level “pipeline” signal is present for lidocaine hydrochloride/epinephrine comparable to novel drug development. Clinical activity in this category typically manifests as: (1) formulation and bioequivalence studies, (2) device-delivery technique studies (e.g., dental cartridge systems), (3) comparative trials versus other local anesthetics or combinations, and (4) post-authorization safety and effectiveness studies tied to labeling updates.

What types of trials are most common for this combination?

Clinical trials for lidocaine HCl and epinephrine generally cluster into:

• Bioequivalence and pharmacokinetic bridging for generic equivalents (often with dental cartridges, injection solutions, and different concentrations).
• Comparative efficacy and safety trials for pain control in procedural settings.
• Studies focused on onset time, duration, anesthetic spread, and hemostasis metrics during minor surgical interventions.
• Tolerability studies addressing cardiovascular and neurologic adverse event monitoring given epinephrine exposure.

Which indications are most often studied?

Across published clinical practice, the combination is used in:

• Dentistry: local infiltration and nerve blocks for restorative dentistry, periodontal procedures, and tooth extractions.
• Dermatology and minor surgery: excision, biopsy, and wound closure.
• Emergency and urgent care: laceration repair and other minor procedures.

Where do trials typically publish results?

For this category, evidence often appears through:

• Journal articles reporting head-to-head anesthesia comparisons.
• Generic sponsor submissions supporting abbreviated regulatory pathways (with trial data embedded in regulatory dossiers).
• Professional guideline updates that incorporate trial evidence rather than registering as new “pipeline” development.

What is the current commercial market for lidocaine hydrochloride and epinephrine, and who sells it?

Market structure

The market is a mature, high-volume, low-differentiation segment. Competitive dynamics are dominated by:

• Multisource generics that are therapeutically equivalent.
• Authorized branded “standard-of-care” products that maintain market presence via channel relationships and contracting rather than patent protection.
• Alternate formulations using other local anesthetics (lidocaine alone, articaine, bupivacaine, mepivacaine) that compete on cost, onset, duration, and provider preference.

Sales geography and channel

Demand tracks procedure volume and reimbursement patterns rather than payer-specific specialty utilization. Buying behavior is largely provider- and health-system procurement driven, with recurring procurement cycles and tenders.

Key customer types

• Dental clinics and dental surgery centers.
• Hospital outpatient surgery and emergency departments.
• Dermatology practices and ambulatory surgical centers.
• Urgent care and trauma services.

How fast is the market growing for lidocaine hydrochloride and epinephrine?

Growth drivers

Market growth for this combination generally follows:

• Rising outpatient procedure volumes in dentistry and minor surgery.
• Increasing demand in emergency care settings.
• Continued preference for lidocaine/epinephrine due to predictable anesthetic effect and reduced bleeding versus anesthetic without vasoconstrictor.
• Substitution within local anesthetic portfolios where lidocaine/epinephrine is favored for cost and workflow.

Growth constraints

• Strong generic competition compresses price growth.
• Shift toward alternative local anesthetic combinations or adjuncts in some clinical protocols.
• Regulatory and procurement pressure to use lowest-cost equivalent products.

Net effect (2026-2031 outlook)

The category is expected to post steady value growth driven mainly by volume and mild price normalization effects, while unit growth is more tied to procedure volumes.

What is the forecast for lidocaine hydrochloride and epinephrine through 2036?

Baseline projection logic

For mature, off-patent drug combinations, forecasts typically use:

• Procedure-volume assumptions (outpatient dentistry and minor surgery).
• Tender-driven price declines partially offset by growth in dispensing.
• Share shifts between lidocaine/epinephrine and competing local anesthetic options.

Category-level forecast direction

• 2026-2031: low-to-mid single digit value CAGR is plausible, with unit growth outpacing value growth due to pricing pressure from generics.
• 2031-2036: continued steady demand, with growth tracking broader ambulatory volume increases and periodic substitution within local anesthetic classes.

Which formulations and strengths matter commercially?

This category’s commercial profile is tied to:

• Concentration and presentation (commonly dental cartridges and injectable solutions).
• Choice of epinephrine concentration for hemostasis and safety profiles.
• Packaging and delivery systems that align with procedural workflow.

Key presentation categories

• Dental cartridge formats for nerve blocks and infiltrations.
• Multi-dose vials for minor surgical procedures.
• Combination concentrations that differ by epinephrine content for balancing hemostasis vs tolerability.

What is the patent and exclusivity landscape for lidocaine hydrochloride and epinephrine?

Patent reality for the active ingredient combination

Lidocaine hydrochloride and epinephrine are long-established compounds. In most jurisdictions, the core combination is widely off patent, leaving limited room for blockbuster-style exclusivity. Remaining IP tends to be concentrated in:

• Specific formulation changes (rare for this core combo).
• Device-integrated delivery concepts (if any).
• Brand-specific method-of-use or secondary patents, which typically do not prevent generic entry if Orange Book “blocking” patents are not present or have expired.

How does this affect competitive entry?

Generic competition is usually enabled by:

• Expired composition patents.
• Lack of unexpired “blocking” patents listed in FDA systems (where applicable).
• Bioequivalence pathways that reduce development time for multisource versions.

What is the Orange Book status and are there active blocking patents?

No current, specific Orange Book listing set can be asserted here without referencing the exact FDA product identifiers for each marketed lidocaine/epinephrine presentation. In this drug class, the dominant market reality is that unexpired blocking patents are uncommon, and generics have substantial penetration.

What generic entry risks exist for lidocaine hydrochloride and epinephrine?

Risk profile

Because the combination is mature, the dominant “entry risk” is not IP enforcement but execution:

• Manufacturing consistency and stability for injectable solutions.
• Supply reliability and compliance quality.
• Channel access and contract awards with health systems and distributors.
• Competitive pricing pressure from incumbent generics.

What clinical endpoint differences matter versus competing local anesthetics?

In practice, procurement and formularies often compare:

• Onset time and duration of analgesia.
• Depth and spread of anesthesia.
• Hemostasis effect (vasoconstriction).
• Adverse event profile, especially epinephrine-linked cardiovascular effects in susceptible patients.
• Provider usability (cartridge design, needle compatibility, volume per procedure).

How does lidocaine hydrochloride and epinephrine compare with alternatives?

Versus lidocaine without epinephrine

• Lidocaine/epinephrine typically improves hemostasis and may extend anesthetic effect via vasoconstriction.
• Lidocaine alone avoids systemic epinephrine exposure but can have higher bleeding in some procedures and shorter duration.

Versus articaine and other local anesthetic combinations

• Articaine-based regimens can be preferred for dental blocks in some settings due to perceived duration and potency.
• Bupivacaine and mepivacaine are used for longer-duration needs but compete on cost and onset characteristics.

Implication for market share

Market share is typically influenced by provider preference and formulary policy, not by major clinical superiority claims.

Key litigation and Paragraph IV events: what to expect?

For this category, patent litigation is usually:

• Episodic and product-specific (brand vs generic), often tied to formulation, labeling, or specific patent listings rather than foundational compound patents.
• Low signal relative to novel drug classes because the core IP has long expired.

Key Takeaways

• Lidocaine hydrochloride/epinephrine is a mature, high-volume local anesthetic combination with growth driven by procedure volume, not new clinical breakthroughs.
• The market is structurally generic-dominated, with value growth constrained by competitive pricing.
• Clinical trials in 2026 are likely to be formulation/bioequivalence and comparative procedural studies rather than new indication-changing development.
• Forecast direction through 2036 is steady, with unit volume tracking outpatient procedure demand and value growth limited by price compression.

FAQs

1) Are there any new FDA approvals for lidocaine hydrochloride and epinephrine combinations in 2026?

No broad, class-defining approval signal exists for this combination category based on typical patterns for mature generics.

2) Does lidocaine with epinephrine have different efficacy in dentistry versus minor surgery?

Clinical use patterns differ by technique (infiltration vs nerve block) and hemostasis requirements, but the active mechanism is consistent; evidence is typically procedural and comparative.

3) What are the main safety concerns clinicians monitor with this combination?

Cardiovascular effects related to epinephrine and local tolerability (injection site reactions), with caution in susceptible patients.

4) Are generics for lidocaine/epinephrine considered interchangeable?

Most products are therapeutic equivalents when matched by concentration and indication labeling; interchangeability is usually governed by formulation and dosing compatibility.

5) What drives formulary decisions for this drug category?

Total cost, perceived reliability of onset/duration, hemostasis performance, procurement contracts, and fit with existing delivery systems.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA. U.S. Food and Drug Administration.
3. Micromedex/Clinical references. Lidocaine and epinephrine prescribing information (class-level).