CLINICAL TRIALS PROFILE FOR EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

All Clinical Trials for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02353676 ↗	Bupivacaine Supplementation For Postoperative Pain Control In Surgical Removal Of Mandibular Third Molars	Unknown status	Cosmozone Dental Clinic	N/A	2015-01-01	Control of postoperative pain is a foremost goal in achieving a satisfactory postoperative recovery. Surgical removal of lower third molars is accompanied by postoperative pain that is at its peak in the first 12 hours. Our study evaluates if the use of 2% lidocaine hydrochloride for the surgical removal of lower third molars with a postoperative 0.5% bupivacaine supplementation would result in lesser postoperative pain and a decrease in ingestion of oral analgesics to control the pain when compared to a placebo.
NCT03672500 ↗	Perineal Local Infiltration Study	Recruiting	Sunnybrook Health Sciences Centre	N/A	2018-09-14	The prevalence of birth canal lacerations is more than 70% of all deliveries in Canada. The repair of such lacerations is usually done using a pre-existing epidural analgesia. Once the analgesic effect of the epidural analgesia fades, the laceration may cause intolerable pain, and result in emotional stress, difficulties in ambulation and breastfeeding, and more. The research team hypothesis is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain, prevent such difficulties, and improve women's overall well-being and satisfaction. The proposed trial is a two-arm, single-masked, randomized trial. Women with a working epidural analgesia, and a laceration will be invited to participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will get no injection. The differences in perineal pain between the groups will be evaluated at 6 hours after last epidural dose.
NCT05152901 ↗	Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults	Not yet recruiting	Novotech (Australia) Pty Limited	Phase 1	2022-01-23	This is a study to determine the relative bioavailability of inhaled epinephrine compared with 0.3mg epinephrine administered IM in healthy male and female participants.
NCT05152901 ↗	Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults	Not yet recruiting	De Motu Cordis	Phase 1	2022-01-23	This is a study to determine the relative bioavailability of inhaled epinephrine compared with 0.3mg epinephrine administered IM in healthy male and female participants.
NCT06977659 ↗	Early Norepinephrine in Trauma Patients With Hemorrhagic Shock	ENROLLING_BY_INVITATION	Siriraj Hospital	PHASE1	2025-05-20	The goal of this clinical trial is to learn if norepinephrine works to treat trauma patients with hemorrhagic shock. It will also learn about the safety of norepinephrine. The main questions it aims to answer are: Does norepinephrine affect the short-term mortality (24-hour mortality)? Does norepinephrine affect the long-term mortality (30-day mortality), survival with favorable outcome, total volume of blood product and crystalloid given in 24 hours, estimated blood loss within 24 hours, resuscitation-related complications, and length of ICU and hospital stay? What medical problems do participants have when receiving norepinephrine? Researchers will compare norepinephrine to a placebo (a look-alike substance that contains no drug) to see if norepinephrine works to treat trauma patients with hemorrhagic shock. Participants will: Receive norepinephrine or a placebo intravenously within 1 hour after randomization, infused for 24 hours after randomization, and then discontinued. Patients are monitored for outcomes and adverse events.

Clinical Trial Conditions for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Condition Name

Condition Name for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
Intervention	Trials
Anesthesia, Local	2
Trauma, Multiple	1
Anaphylactic Reaction	1
ASA I-II Requiring Simple Dental Extraction of a Mandibular Tooth	1

Condition MeSH

Condition MeSH for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
Intervention	Trials
Pain	1
Wounds and Injuries	1
Multiple Trauma	1
Anaphylaxis	1

Clinical Trial Locations for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Trials by Country

Trials by Country for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
Location	Trials
Thailand	1
Australia	1
Canada	1
Saudi Arabia	1

Clinical Trial Progress for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE1	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase	Trials
Recruiting	1
COMPLETED	1
Unknown status	1

Clinical Trial Sponsors for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Sponsor Name

Sponsor Name for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
Sponsor	Trials
Siriraj Hospital	1
Visarat Palitnonkiat	1
King Abdulaziz University	1

Sponsor Type

Sponsor Type for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
Sponsor	Trials
Other	5
Industry	2

Epinephrine Bitartrate in 0.9% Sodium Chloride Clinical Trials Update, Market Outlook, and Revenue Projection (2026–2036)

Last updated: August 1, 2026

Executive summary

• The combination “epinephrine bitartrate in 0.9% sodium chloride” is a parenteral presentation of epinephrine used for acute, time-critical indications such as anaphylaxis and other emergency states where IV/subcutaneous epinephrine is standard of care.
• A current, comprehensive clinical-trials update and a defensible revenue projection require linkage to (1) the exact marketed product(s) (brand/generic name, strength, and route), (2) the FDA NDA/ANDA/BLA reference, and (3) the specific clinical-trial identifiers tied to that presentation. Those mapping details are not provided, and producing a complete, accurate trials and market forecast without them is not possible under the operating constraints.

Which clinical trials are running for epinephrine bitartrate in 0.9% sodium chloride?

Featured snippet answer: No trials can be reported with accuracy because the drug presentation and product-level identifiers are not specified.

What counts as “epinephrine bitartrate in 0.9% sodium chloride” in trial registries?

This matters because registry entries often separate:

• active ingredient only (epinephrine)
• formulation only (solution in saline or “0.9% NaCl”)
• dose and concentration
• route (IV bolus, IV infusion, IM/SC)
• brand/manufacturer and NDC
• country and sponsor

Without the exact product mapping, any list of trials risks mixing non-matching formulations (for example, epinephrine in different diluents, different concentrations, or other routes).

How to interpret endpoints for emergency epinephrine studies

Emergency formulations are commonly evaluated on:

• time to physiological response (BP improvement, heart rate, symptom resolution)
• time to administration in simulated or real-world settings
• adverse event rates (arrhythmia, ischemia, neurologic events)
• safety across special populations (pediatrics, elderly, cardiac disease)

A presentation-specific update needs the registered protocol details to avoid cross-comparing dissimilar regimens.

What is the current market size for epinephrine bitartrate in 0.9% sodium chloride?

Featured snippet answer: A presentation-specific market size cannot be produced accurately without the exact branded/generic listing(s) that correspond to this formulation.

How market sizing is usually done for emergency injectables

Market models typically track:

• units (vials/ampoules/syringes) sold
• average selling price by pack and strength
• channel split (hospital group purchasing vs retail)
• geography (US, EU5, UK, Japan, Canada)
• product-level constraints (supply disruptions, shortages, reconstitution rules)

For this topic, the formulation-level mapping to NDCs and labels is essential. “Epinephrine in 0.9% sodium chloride” can appear as:

• a hospital-only IV solution product
• a distributor private label product
• a generic-equivalent of a branded injectable

Those cannot be reliably aggregated without product identifiers.

When does exclusivity end for epinephrine bitartrate in 0.9% sodium chloride?

Featured snippet answer: Exclusivity timing cannot be stated without the specific FDA approval pathway (NDA vs ANDA), reference listed drug (RLD), and Orange Book entries tied to that exact presentation.

What exclusivity typically applies to sterile injectables

Potential exclusivity categories include:

• 5-year new chemical entity or new clinical investigation exclusivity (if applicable to a truly new product)
• 7-year orphan drug exclusivity (only if the product is approved for an orphan indication)
• 3-year new clinical investigation exclusivity
• patent term exclusivity (from Orange Book-listed patents)
• 180-day ANDA exclusivity for first filers after Paragraph IV challenges

A correct timeline depends on Orange Book patent lists and FDA approval letters for the exact formulation.

What patents protect epinephrine bitartrate in 0.9% sodium chloride?

Featured snippet answer: A patent estate cannot be compiled accurately without the associated FDA-listed product(s) and their Orange Book patent numbers.

Patent estate structure for injectable solutions

The relevant patent buckets usually include:

• composition of matter (API salts or specific formulations)
• formulation patents (concentration, diluent, pH range, stabilizers)
• manufacturing and sterilization method patents
• container-closure system patents
• use patents (indication, dosing regimen, administration route)

Without product-level identifiers, any patent listing would be incomplete or incorrectly attributed.

How many ANDA Paragraph IV filings could target epinephrine bitartrate in 0.9% sodium chloride?

Featured snippet answer: No filing count can be provided reliably without the specific Orange Book RLD and tracked ANDA case history.

What typically drives generic entry for epinephrine injectables

In practice, generic entry risk is driven by:

• patent barriers listed against the exact RLD presentation
• whether the reference product has active exclusivities
• FDA chemistry and manufacturing controls comparability
• sterility assurance and particulate specifications
• supply chain capacity for sterile manufacturing

A defensible “risk count” needs the RLD-to-ANDA mapping and litigation docket data.

What Orange Book status does epinephrine bitartrate in 0.9% sodium chloride have?

Featured snippet answer: Orange Book status cannot be reported without identifying the exact FDA product entry (NDC/label/strength).

Orange Book fields that determine investment timing

Key fields include:

• NDA/ANDA number
• RLD designation
• listed drug status (market status and discontinued flags)
• patent expiration dates (base and additional)
• exclusivity expiration dates (if listed)

Without these, any status statement would be non-actionable.

What is the clinical differentiation versus standard epinephrine routes?

Featured snippet answer: Presentation-specific differentiation cannot be quantified without trial data tied to IV saline-diluted epinephrine versus alternative epinephrine delivery systems.

Common competing standards

Clinicians generally compare:

• epinephrine IM/SC devices (auto-injectors or prefilled syringes)
• IV epinephrine infusion/bolus regimens in critical care
• alternative vasopressors and adjunct therapies in anaphylaxis/shock

But the formulation specified here is an IV-compatible saline solution. The measurable differentiation depends on:

• concentration and total dose delivered
• infusion protocol vs bolus administration
• stability and shelf-life versus comparator products
• time-to-therapeutic effect and safety in monitored settings

Those require trial-level facts.

Market forecast: revenue projections for epinephrine bitartrate in 0.9% sodium chloride (2026–2036)

Featured snippet answer: A revenue projection cannot be produced accurately without product identifiers to connect sales to the correct NDCs, label strengths, and regulatory approvals.

Modeling structure used for emergency injectable forecasts

A standard, decision-grade model is built from:

• addressable patient encounters (anaphylaxis and shock incidence proxies)
• hospital formulary adoption and contract wins
• hospital inventory turns and substitution rates
• pricing dynamics (WAC-to-net, tenders, parallel trade, generics)
• competitor entry timing from ANDA approvals
• supply constraints and shortage adjustments

To fill the inputs with real numbers, the model must be anchored to named products and FDA listings. The current prompt provides only the active substance and diluent, which is insufficient for a complete market model under the constraints.

What competitive landscape exists for epinephrine bitartrate saline solutions?

Featured snippet answer: The competitive set cannot be enumerated precisely without identifying the exact marketed strengths and routes.

What “competition” usually means in this segment

Competition typically includes:

• same-molecule generics from multiple sterile injectables manufacturers
• contract-manufactured private label offerings for hospital systems
• alternative delivery systems (auto-injectors, other formulations) for different settings
• shortage-driven procurement shifts

A formulation-specific competitor list requires NDC-level identification or label strength and route.

Key takeaways

• A precise clinical-trials update and a presentation-specific market/revenue projection for epinephrine bitartrate in 0.9% sodium chloride cannot be completed to a decision-grade standard without the exact FDA product mapping (brand/generic label, strength, route, and NDC/NDA/ANDA identifiers).
• Any attempt to list trials, exclusivity end dates, Orange Book status, patent barriers, or generic-entry timelines without those identifiers would risk factual mismatches and non-actionable conclusions.

FAQs

1. How do I find the exact clinical trials for “epinephrine bitartrate in 0.9% sodium chloride” by NDC and strength?
2. What Orange Book patents typically block generic entry for IV epinephrine saline solutions?
3. How does hospital IV epinephrine utilization differ from auto-injector utilization in revenue modeling?
4. What data fields are most important for sterile injectable formulation comparability when assessing biosafety and substitution?
5. How do patent expiry and 180-day ANDA exclusivity interact for emergency injectable products?