CLINICAL TRIALS PROFILE FOR LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01348243 ↗	Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis	Completed	Chiesi Farmaceutici S.p.A.	Phase 3	2011-10-01	Clodronic acid 100 mg/3,3 ml is used to prevent and treat postmenopausal osteoporosis. The intramuscular formulation, which is given at a dose of 100 mg every 7 o 14 days, is at least as effective as daily oral therapy and appears more effective than intermittent intravenous treatment. Intramuscular clodronic acid in particular has also been associated with improvements in back pain. The drug is well tolerated, with no deleterious effects on bone mineralization, and use of parenteral therapy eliminates the risk of gastrointestinal adverse effects that may be seen in patients receiving oral bisphosphonates therapy. In order to simplify the therapeutic dosing regimen, reducing the number of administrations per month, and therefore increase adherence to bisphosphonates therapy of the patient, a new formulation of disodium clodronic acid containing 200 mg/4 mL for i.m. administration has been developed. Lidocaine in this new formulation, as local anaesthetic, is maintained at the same concentration as in the 100 mg clodronic acid formulation. The pharmacokinetics and tolerability of the intramuscular formulation of clodronic acid 200 mg in comparison to the marketed formulation clodronic acid 100 mg was evaluated in healthy post-menopausal volunteers. Two formulations were similar in terms of amount and rate of clodronic acid urinary excretion and in terms of safety profile.
OTC	NCT02229539 ↗	Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 3	2014-11-01	The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
OTC	NCT02229539 ↗	Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy	Completed	Alliance for Clinical Trials in Oncology	Phase 3	2014-11-01	The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
OTC	NCT02749123 ↗	Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis	Unknown status	J.A.R. Laboratories	N/A	2016-04-01	A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.
New Formulation	NCT04026945 ↗	Sustained Release Lidocaine for Treatment of Scrotal Pain	Completed	University of British Columbia	Phase 1/Phase 2	2019-10-31	In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing chronic scrotal pain (CSCP). The new formulation ST-CP is a lidocaine sustained-release formulation and is expected to provide pain relief over 4 weeks. Currently, the drug lidocaine is not available as an injectable slow-release formulation and chronic scrotal pain patients are often left untreated.

All Clinical Trials for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001303 ↗	Effects of Endotoxin in Normal Human Volunteers	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	1992-04-06	Bacterial infections can progress to a life-threatening illness called septic shock, characterized by low blood pressure and vital organ damage. The syndrome is thought to be caused by parts of the bacteria and by the body s own immune response to the infection. A major bacterial product that interacts with the immune defenses is called endotoxin. This study will examine the body s response to endotoxin in the lungs or bloodstream. When endotoxin is given in small amounts to humans, even though it is not an infection, it triggers a set of responses that are typical of what one would see with a true bacterial infection. This allows us to study the earliest changes in molecules and cells that are involved in some bacterial infections. This type of model is safe and has been used in humans for many years to understand the body s responses during infections. Normal volunteers 18 to 45 years of age may be eligible for this study. Candidates will have a history and physical examination, blood and urine tests, electrocardiogram (EKG) and chest X-ray. In addition, volunteers 40 to 45 years old will have an exercise stress test to screen for asymptomatic coronary artery disease. Participants will undergo one or more of the following procedures: Bronchoscopy, Bronchoalveolar Lavage, Bronchial Brushings, and Endobronchial Mucosal Biopsies: These techniques for examining lung function are used routinely in patient care and clinical research. The mouth and nasal and lung airways are numbed with an anesthetic. A bronchoscope (pencil-thin flexible tube) is then passed through the nose into the large airways of the lung. Cells and secretions from the airways are rinsed with salt water (bronchoalveolar lavage) and a flexible brush the size of a pencil tip is passed through the bronchoscope to scrape cells lining the airways. Lastly, pieces of tissue (the size of the ball of a ballpoint pen) lining the airways are removed for examination under the microscope. Intravenous Endotoxin: A small dose of endotoxin is injected into a vein. Blood samples are drawn at regular intervals for 8 hours after the injection and again after 1, 2, 3, 7 and 14 days to analyze the body s immune response to the bacteria in the blood. Instilled Endotoxin in the Lungs: A small amount (2 teaspoons) of salt water is squirted through a bronchoscope into a lobe of one lung, and then salt water containing a small dose of endotoxin is squirted into the other lung. Bronchial lavage, brushing, and biopsy (see above) are then done to study the response of the lung to the endotoxin. In addition, air is withdrawn through the bronchoscope to study air components from the lung that was instilled with salt water or endotoxin. Nitric Oxide Therapy: Endotoxin is instilled in a lung (see above) and then nitric oxide a colorless, odorless, tasteless gas mixed with room air in a concentration of 40 parts per million, is given through a cushioned mask placed over the mouth and nose. (Some participants will be given the nitric oxide mixture and others will breathe only room air through the mask to test the effects of the nitric oxide on the lung inflammation.) The mask will be worn continuously for 6 hours and removed before repeat bronchoscopy with lavage, brushing and biopsy. Some of the above procedures require placement of a catheter (thin plastic tube) in a wrist artery to monitor blood pressure from heartbeat to heartbeat and to collect blood samples. First, the skin is numbed with an anesthetic (lidocaine). A needle is then inserted into the artery, the catheter is slipped over the needle into the vessel, and the needle is removed.
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.
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.
NCT00001784 ↗	Mexiletine for the Treatment of Focal Dystonia	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	1998-07-01	Dystonia refers to a condition characterized by involuntary muscle contractions that may cause pain, abnormal posture, or abnormal movements. The cause of dystonia is unknown, but some researchers believe it is a result of overactivity in the areas of the brain responsible for movement (basal ganglia). Lidocaine is a drug used for the treatment of irregular heartbeats. It is given by injection. Recent studies have shown that lidocaine is also effective for the treatment dystonia. Mexiletine is a drug similar to lidocaine used for irregular heartbeats that can be taken by mouth. Researchers would like to test the effectiveness of Mexiletine for the treatment of dystonia. Patients participating in the study will be divided into two groups; Group 1 will take Mexiletine for six weeks then stop. They will remain drug free for one week then begin taking a placebo "inactive sugar pill" for an additional six weeks. Group 2 will take a placebo "inactive sugar pill" for six weeks then stop. They will remain drug free for one week then begin taking a Mexiletine for an additional six weeks. Throughout the study researchers will test the effectiveness of the treatment by evaluating patients using clinical rating scales and neurophysiological studies. In addition, researchers will test patient's reflexes in an attempt to find out where mexiletine works in the nervous system.
NCT00002901 ↗	Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function	Completed	National Cancer Institute (NCI)	Phase 1	1996-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of docetaxel in treating patients with advanced solid tumors that have not responded to standard therapy or for which there is no effective therapy.

Clinical Trial Conditions for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Condition Name

Condition Name for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
Intervention	Trials
Pain	204
Postoperative Pain	91
Pain, Postoperative	80
Anesthesia	71

Condition MeSH

Condition MeSH for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
Intervention	Trials
Pain, Postoperative	238
Neuralgia	56
Acute Pain	45
Agnosia	40

Clinical Trial Locations for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Trials by Country

Trials by Country for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
Location	Trials
Egypt	232
Canada	121
China	93
France	65
Brazil	54

Trials by US State

Trials by US State for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
Location	Trials
California	127
New York	74
Pennsylvania	66
Texas	64
North Carolina	58

Clinical Trial Progress for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	74
PHASE3	32
PHASE2	39

Clinical Trial Status

Clinical Trial Status for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	1033
Recruiting	368
Unknown status	208

Clinical Trial Sponsors for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
Sponsor	Trials
Assiut University	57
Cairo University	45
Ain Shams University	36

Sponsor Type

Sponsor Type for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
Sponsor	Trials
Other	2346
Industry	221
U.S. Fed	49

Last updated: July 28, 2026

Lidocaine Hydrochloride in Plastic Container Clinical Trials Update, Market Analysis, and Forecast: Patents, Generics, and FDA Commercial Outlook

Executive summary

• Clinical development: No new, drug-specific clinical trial readouts were identified for “lidocaine hydrochloride in plastic container” as a distinct FDA-regulated product type. Lidocaine (including lidocaine HCl) is widely marketed as an established local anesthetic with mature generics, and trial activity is generally centered on new formulations, delivery systems, or combinations rather than the container format alone.
• Patent landscape: “Lidocaine HCl in plastic container” is typically not associated with a unique, container-specific innovation estate. Market access is more commonly determined by formulation, concentration, preservative system, sterility assurance, and device-like delivery system claims rather than the plastic container per se.
• Market outlook: Volume growth is more exposed to U.S. and ex-U.S. price compression, hospital procurement cycles, and generic penetration than to incremental IP-backed expansion. Near-to-medium-term revenue projections skew modest unless a branded manufacturer holds differentiating IP around the particular container/closure system, label indications, or extended stability data.

The sections below map what can be acted on for R&D, licensing, and market entry using the drug’s established nature: trial visibility, regulatory pathways, and generic entry risk.

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What clinical trials exist for lidocaine hydrochloride in plastic container and what are the latest readouts?

Direct answer: Trial activity for lidocaine HCl is typically not tracked against the container format alone. The label-visible clinical evidence is usually tied to lidocaine HCl injectable (and sometimes related local anesthetic indications) rather than a specific packaging category.

Where do new studies usually show up for lidocaine HCl products?

High-intent clinical updates for lidocaine HCl tend to cluster in these buckets:

• Efficacy/safety in specific procedures (regional anesthesia, dental, peripheral nerve blocks, topical infiltration)
• PK/PD comparisons across formulations or concentrations
• Stability and sterility testing tied to production changes or packaging
• Device-adjacent delivery (e.g., catheters or co-packaged administration systems)

What would constitute a meaningful “clinical trial update” for a container format claim?

To move the needle for “lidocaine HCl in plastic container,” a trial readout would normally be anchored to at least one of:

• A stability comparison impacting shelf life or delivered dose
• Compatibility data for the container/closure system affecting impurity profiles
• A bioequivalence study if a new formulation changes pharmacokinetics meaningfully
• An indication expansion or comparative safety trial in a defined clinical setting

No such drug-specific, container-format trial readout can be concretely listed here as a distinct update, consistent with the category’s established generic market.

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How does the FDA regulate lidocaine hydrochloride injectable products in plastic containers, and what pathways matter for entry?

Direct answer: Most lidocaine HCl injectable products reach the market via ANDAs for generic injectables or through legacy approvals where applicable. Packaging and formulation changes typically follow CBE-30/CBE-0 or prior approval supplement routes, depending on what changes.

What regulatory levers shape packaging-specific differentiation?

For “lidocaine HCl in plastic container,” the practical regulatory levers are:

• Container-closure system compatibility
• Sterility assurance
• Extractables/leachables
• Stability and impurity profiles
• Fill volume and deliverability
• Device-like usability affecting administration workflow

Why this matters for competitors

In practice, challengers can often enter without container-format IP if they can:

• Demonstrate bioequivalence where required
• Hold an approved NDA/ANDA pathway with stability data acceptable to FDA
• Avoid infringing formulation or method claims

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What patents protect lidocaine hydrochloride in plastic container, and how strong is the patent estate?

Direct answer: The patent estate most likely relevant to container-format products is not “the container” but formulation, concentration, manufacturing, stability, and compatibility.

Patent estate reality for established lidocaine HCl injectables

For generic-heavy local anesthetics:

• Many composition-of-matter protections on lidocaine itself expired long ago.
• The remaining IP often sits in process, stability, impurity control, or container-closure compatibility.
• Claims can be product-specific, but they are still usually narrower than a broad platform.

How to evaluate “strength” for licensing or litigation

Use a three-layer screen:

1. Claim scope: Does the claim require a particular preservative, pH, concentration range, or impurity limit?
2. Evidence of infringement: Are the accused products demonstrably within the claimed parameters?
3. Remaining life: Are there enforceable claims scheduled to end within 0 to 5 years?

Without a product-specific patent list here, the actionable conclusion is: container format alone is rarely a durable barrier; differentiating IP must be tied to formulation/process elements.

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When does lidocaine hydrochloride in plastic container lose exclusivity, and what drives generic timing?

Direct answer: Exclusivity timing is driven by:

• Any remaining data exclusivity tied to a specific NDA (rare for an old generic category unless a newer branded SKU exists)
• Any remaining patent term linked to formulation/process
• Any market exclusivity tied to a specific FDA-approved change

What typically drives the U.S. launch calendar in this category

• ANDA filing readiness (stability packaging data)
• Patent litigation status, if any listed in the Orange Book
• Manufacturing scale-up and batch release timelines
• Hospital formularies and purchasing contracts

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How many Orange Book listings exist for lidocaine hydrochloride injectable packaging, and what do they cover?

Direct answer: Orange Book coverage for lidocaine HCl injectables is typically extensive across multiple holders and strengths, but container-format specificity is often indirect (listed patents tend to map to product-level formulations or processes, not to packaging categories).

What to look for in Orange Book entries

For an actionable view, sort by:

• Patent type: composition, method of use, formulation, packaging compatibility, process
• Expiration: earliest termination date by granted claim
• Listed drug products: exact strength and dosage form
• Holder/assignee: identify likely primary licensors and litigants

A decisive entry risk forecast depends on identifying:

• Whether packaging-compatibility or formulation patents are listed for the exact strength
• Whether any Orange Book patents are actively litigated or recently settled

No concrete Orange Book entry counts or patent numbers can be listed here without product identification.

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Which companies supply lidocaine hydrochloride injectable in plastic containers, and how competitive is the market?

Direct answer: Competition is structurally high. Lidocaine HCl injectables are widely supplied by:

• Major generic manufacturers with sterile injectables portfolios
• Contract manufacturers supporting multiple NDA/ANDA labels
• Regionally dominant distributors in hospitals and ambulatory surgical centers

What competition looks like commercially

• Price compression after generic entry
• Tender-based switching in hospitals
• Concentration and presentation (vial vs prefilled syringe vs plastic container formats) as procurement drivers
• Brand loyalty only where device handling or stability claims reduce workflow risk

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What market size and revenue projections are plausible for lidocaine hydrochloride injectable products in plastic containers?

Direct answer: Revenue is best modeled on generic penetration and unit price declines, not on container-format innovation.

Revenue model drivers

1. Unit volume growth: procedure volumes for regional anesthesia and pain control
2. Price erosion: post-generic entry declines and ongoing tender pressure
3. Mix shift: any movement to particular containers that reduce administration errors or waste
4. Ex-US share: procurement systems and reimbursement regimes

Practical forecast range (category-level)

• Baseline case: low-to-mid single-digit revenue CAGR driven by volume, offset by price compression
• Downside case: faster tender-driven price declines or additional generic entrants
• Upside case: a differentiated container-closure system that improves stability or usability, sustaining premium within hospital formularies

Because the request targets “lidocaine hydrochloride in plastic container” specifically, not the broader lidocaine injectable class, the forecast cannot be made more precise without product-level SKU data.

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What generic entry risks exist for lidocaine hydrochloride in plastic containers under Paragraph IV?

Direct answer: Paragraph IV risk exists only when:

• A filer seeks approval of a generic lidocaine HCl injectable AND
• The Orange Book lists relevant unexpired patents for the same strength/dosage form
• The generic strategy includes any chemical formulation, compatibility, or process equivalence that could fall inside listed claims

How packaging specifics change Paragraph IV mechanics

Container-closure compatibility claims can:

• Increase the likelihood of disputes
• Require additional stability and extractables evidence
• Make “design-around” harder if claims use defined material properties or impurity thresholds

In most older local anesthetics, however, generic entrants can often route around narrow, process-linked claims by adjusting manufacturing parameters or formulation details while staying within FDA equivalence requirements.

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What does lidocaine hydrochloride injection compete against, and how does it compare with other local anesthetics?

Direct answer: The competitive set is broader than lidocaine HCl injectables and includes:

• Other amide local anesthetics (e.g., bupivacaine, ropivacaine)
• Topicals and combination anesthetic products
• Procedure-specific anesthesia protocols

Why lidocaine HCl remains central

• Cost and availability
• Broad procedural use
• Long-standing clinician familiarity
• Regulatory maturity for sterile injectables

Container format can matter in workflow, but it is not typically a clinical superiority lever strong enough to counter generic price competition.

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Key Takeaways

• Lidocaine HCl injectables are mature, and “plastic container” packaging alone is rarely enough to anchor a standalone clinical-trial update or a durable patent barrier.
• Market dynamics are dominated by generic penetration, hospital procurement, and price erosion, with incremental packaging-driven gains limited to usability and stability differentiation.
• Patent and exclusivity analysis must focus on formulation/process/compatibility claims tied to the exact strength and dosage form, rather than the packaging concept broadly.
• For market entry or licensing, the actionable risk is whether any remaining Orange Book-listed patents cover the specific product parameters (preservative system, pH, impurity limits, container-closure compatibility) and whether those are enforceable and in active dispute.

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FAQs

1. Does lidocaine hydrochloride container-closure compatibility drive patent disputes in generics?
2. Are bioequivalence studies required when switching container types for lidocaine HCl injectables?
3. How do hospital formularies evaluate usability differences between prefilled plastic containers and vials for lidocaine HCl?
4. What manufacturing changes most often trigger regulatory supplements for lidocaine hydrochloride sterile injectables?
5. What indicators best predict accelerated generic price erosion for sterile local anesthetics like lidocaine HCl?

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References (APA)

1. FDA. (n.d.). Drugs@FDA. U.S. Food and Drug Administration.
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
3. FDA. (n.d.). Guidance for Industry: Changes to an Approved NDA or ANDA. U.S. Food and Drug Administration.