Last Updated: August 10, 2026

CLINICAL TRIALS PROFILE FOR BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE


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All Clinical Trials for bupivacaine hydrochloride; epinephrine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00298571 ↗ Cesarean Delivery and Post-operative Pain Management With Local Anesthesia Completed University of South Florida Phase 2/Phase 3 2006-02-01 The use of .5% Bupivacaine with epinephrine at the time of skin closure in cesarean deliveries will decrease post-op pain.
NCT00458003 ↗ Phenylephrine in Spinal Anesthesia in Preeclamptic Patients Completed Northwestern University N/A 2006-07-01 Hypotension remains a common clinical problem after induction of spinal anesthesia for cesarean delivery. Maternal hypotension has been associated with considerable morbidity (maternal nausea and vomiting and fetal/neonatal acidemia). Traditionally, ephedrine has been the vasopressor of choice because of concerns about phenylephrine's potential adverse effect on uterine blood flow. This practice was based on animal studies which showed that ephedrine maintained cardiac output and uterine blood flow, while direct acting vasoconstrictors, e.g., phenylephrine, decreased uteroplacental perfusion. However, several recent studies have demonstrated that phenylephrine has similar efficacy to ephedrine for preventing and treating hypotension and may be associated with a lower incidence of fetal acidosis. All of these studies have been performed in healthy patients undergoing elective cesarean delivery. Preeclampsia complicates 5-6% of all pregnancies and is a significant contributor to maternal and fetal morbidity and mortality. Many preeclamptic patients require cesarean delivery of the infant. These patients often have uteroplacental insufficiency. Given the potential for significant hypotension after spinal anesthesia and its effect on an already compromised fetus, prevention of (relative) hypotension in preeclamptic patients is important. Spinal anesthesia in preeclamptic patients has been shown to have no adverse neonatal outcomes as compared to epidural anesthesia when hypotension is treated adequately. Due to problems related to management of the difficult airway and coagulopathy, both of which are more common in preeclamptic women, spinal anesthesia may be the preferred regional anesthesia technique. Recent studies have demonstrated that preeclamptic patients may experience less hypotension after spinal anesthesia than their healthy counterparts. To our knowledge, phenylephrine for the treatment of spinal anesthesia-induced hypotension has not been studied in women with preeclampsia. The aim of our study is to compare intravenous infusion regimens of phenylephrine versus ephedrine for the treatment of spinal anesthesia induced hypotension in preeclamptic patients undergoing cesarean delivery. The primary outcome variable is umbilical artery pH.
NCT00519584 ↗ Interscalene Nerve Blocks With Ropivacaine Alone, With Dexamethasone, Plus Systemic Dexamethasone Terminated The Cleveland Clinic N/A 2007-07-01 This study will test the hypothesis that ropivacaine in combination with either systemic or local steroid provides comparably longer-lasting analgesia tha ropivacaine alone.
NCT00531349 ↗ Regional Anesthesia and Endometrial Cancer Recurrence Withdrawn The Cleveland Clinic Phase 3 2007-11-01 The purpose of this study is to determine whether recurrence of local and metastatic cancer after open hysterectomy for stage 1 or 2 endometrial cancer is reduced when patients receive epidural anesthesia/analgesia combined with propofol sedation rather than sevoflurane anesthesia and opioid analgesia.
NCT00636415 ↗ Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis Completed Federal University of São Paulo N/A 2004-06-01 CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of elderly people. The aim of the present study was to compare the analgesic effect of intra-articular bupivacaine and morphine in patients with knee osteoarthritis. DESIGN AND SETTING: A randomized and double-blind study was performed at a Pain Clinic of São Paulo Federal University. METHODS: Thirty-nine patients with pain for more than 3 months and an intensity higher than 3 on a numerical scale (zero to 10) were included. G1 patients received 1 mg (1 ml) morphine diluted in 9 ml saline by the intra-articular route, and G2 patients received 25 mg (10 ml) 0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee flexion and extension angles were measured after administration of the drugs at rest and during movement. The total amount of analgesic complementation with 500 mg paracetamol was also determined.
NCT00813111 ↗ Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation Terminated Pacira Pharmaceuticals, Inc Phase 3 2008-11-01 The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative pain management contributes to faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
NCT00871442 ↗ Parturient Controlled Epidural Analgesia (PCEA) With or Without a Basal Infusion for Early Labor Withdrawn Neil Roy Connelly, MD Phase 3 2009-05-01 Patient Controlled Epidural Analgesia is a widely used and effective means of adult pain management. However, Parturient Controlled Epidural Analgesia (PCEA) is a relatively new approach to pain control for the women in labor. With the recent acquisition of new PCEA technology at Baystate Medical Center it is now possible to make this patient controlled technology available on the Labor and Delivery unit. This study is designed to determine whether there is a difference in analgesia, side effects, or analgesic duration in patients who receive a bupivacaine and fentanyl PCEA for management of labor pain. The present study hypothesizes that an analgesic protocol that includes a basal infusion rate in addition to a bolus dose controlled by the patient will have a longer analgesic duration than a pump protocol that does not have a basal infusion added to a bolus dose controlled by the patient. Methods:The study population will consist of 100 adult obstetrical patients greater than 36 weeks gestation who request labor analgesia. Patients greater than 5 cm cervical dilation, patients who have received intravenous opioid agonists, or patients with a contraindication to fentanyl will be excluded. Patients with pre-eclampsia are also excluded. One of the following PCEA treatment protocols will be started in a randomized, double blind fashion.PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml Group 1: Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout) Group 2: Basal Infusion: 10 ml/h; Bolus 5 ml q 30min prn (5ml demand dose with 30min lockout) If the patient does not obtain relief within 30 minutes, the epidural catheter will be dosed with a local anesthetic and the study will be concluded. The patients without pain relief within 30 minutes are considered to have failed epidurals and are dropped from the study and the analysis. Following achievement of satisfactory analgesia, the patient will be evaluated every 30 minutes until they request additional analgesics. The study will "end" at this point, and the patient will be treated at the discretion of the anesthesiologist.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for bupivacaine hydrochloride; epinephrine

Condition Name

Condition Name for bupivacaine hydrochloride; epinephrine
Intervention Trials
Postoperative Pain 23
Pain, Postoperative 22
Pain 16
Analgesia 10
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Condition MeSH

Condition MeSH for bupivacaine hydrochloride; epinephrine
Intervention Trials
Pain, Postoperative 58
Acute Pain 13
Osteoarthritis 10
Agnosia 6
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Clinical Trial Locations for bupivacaine hydrochloride; epinephrine

Trials by Country

Trials by Country for bupivacaine hydrochloride; epinephrine
Location Trials
United States 99
Canada 23
Egypt 15
Brazil 6
Chile 3
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Trials by US State

Trials by US State for bupivacaine hydrochloride; epinephrine
Location Trials
New York 11
Massachusetts 9
California 9
Texas 8
North Carolina 8
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Clinical Trial Progress for bupivacaine hydrochloride; epinephrine

Clinical Trial Phase

Clinical Trial Phase for bupivacaine hydrochloride; epinephrine
Clinical Trial Phase Trials
PHASE4 8
PHASE3 3
PHASE2 4
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Clinical Trial Status

Clinical Trial Status for bupivacaine hydrochloride; epinephrine
Clinical Trial Phase Trials
Completed 76
Recruiting 38
Not yet recruiting 24
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Clinical Trial Sponsors for bupivacaine hydrochloride; epinephrine

Sponsor Name

Sponsor Name for bupivacaine hydrochloride; epinephrine
Sponsor Trials
Federal University of São Paulo 6
University of California, San Diego 6
Wake Forest University Health Sciences 5
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Sponsor Type

Sponsor Type for bupivacaine hydrochloride; epinephrine
Sponsor Trials
Other 216
Industry 10
U.S. Fed 6
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Last updated: July 28, 2026

Bupivacaine Hydrochloride With Epinephrine Clinical Trials Update, Market Analysis, and Sales Projection (2026-2035)

Executive summary

Bupivacaine hydrochloride with epinephrine remains a niche but defensible injectable local anesthetic franchise. Demand is driven by outpatient anesthesia volumes, ambulatory surgery growth, and clinician preference for longer duration and reduced bleeding from epinephrine vasoconstriction. Near-term competitive pressure is concentrated in generic short-acting local anesthetic combinations and “interchangeable” ampule/vial presentations rather than differentiated clinical claims. Clinical-trials activity is mostly incremental (formulation, manufacturing changes, concentration or dosing regimen studies), with limited evidence of broad mechanism-expanding development. A practical sales outlook through 2035 is therefore tied to procedure volumes, substitution/brand retention in anesthesia kits, and procurement dynamics for generic equivalents.

Projected revenue trajectory (global, all presentations; injectable local anesthetic with epinephrine):

  • 2026E: $0.9–1.3B
  • 2030E: $1.1–1.6B
  • 2035E: $1.3–2.1B

Range drivers: growth in outpatient procedures vs. generic penetration, regulatory and supply stability, and hospital formulary shifts toward lowest acquisition cost.

Clinical trials emphasis (typical for this class): pharmacokinetics (PK), onset/duration mapping, safety in regional anesthesia, and product equivalence after manufacturing or formulation changes.


What clinical trials are ongoing for bupivacaine hydrochloride with epinephrine?

Answer: Most ongoing work is expected to be in regional anesthesia settings with endpoints focused on onset time, duration of sensory block, motor block profile, safety, and PK variability. Development is usually about product-specific performance rather than new indications, because the active moiety and clinical role are well established.

What trial endpoints matter for this drug combination

Common study designs and endpoints reported for local anesthetic plus vasoconstrictor combinations typically include:

  • Onset time for sensory block and analgesia
  • Time to first rescue analgesia
  • Duration of sensory block and motor block
  • Hemodynamic safety (heart rate, blood pressure changes attributable to epinephrine)
  • Incidence of adverse events (CNS symptoms, local tissue reactions, systemic toxicity signals)
  • PK parameters for bupivacaine (Cmax, Tmax, AUC) where feasible

Which settings drive enrollment

Studies frequently cluster in:

  • Dental anesthesia and minor oral surgeries
  • Peripheral nerve blocks (upper and lower extremity)
  • Infiltration anesthesia for laceration repair and minor procedures
  • Regional anesthesia supporting orthopedic and general surgery workflows

What’s usually being studied

Incremental clinical work typically focuses on:

  • Concentration and dose mapping across age groups and surgical contexts
  • Equivalence between manufacturers’ presentations
  • Stability or manufacturing consistency for injectable sterile products
  • Post-market comparative safety or effectiveness studies

How is the market for bupivacaine hydrochloride plus epinephrine evolving?

Answer: Market expansion is primarily volume-led (procedures), while value is margin-led (generic mix). Epinephrine-containing bupivacaine maintains clinician and formulary use because it improves anesthetic duration and reduces operative bleeding, which supports throughput in ambulatory settings.

Demand drivers

  1. Ambulatory surgery growth: More procedures shift to outpatient pathways where local anesthesia supports faster recovery and discharge.
  2. Regional anesthesia adoption: Expansion of nerve blocks and infiltration techniques supports sustained local anesthetic demand.
  3. Workflow benefits from epinephrine: Longer duration and local hemostasis reduce need for repeat dosing in many protocols.
  4. Clinician familiarity: Established safety profiles and dosing protocols reduce perceived development risk for prescribers.

Offsetting forces

  1. Generic substitution: Multi-source supply compresses brand pricing.
  2. Procurement leverage: Hospital pharmacy and group purchasing organizations push acquisition cost down.
  3. Formulary standardization: Hospitals reduce SKUs, favoring limited “preferred” suppliers.

Pricing dynamics

Revenue growth is usually slower than procedure volume growth because generic price erosion offsets utilization increases.


What is the competitive landscape for bupivacaine hydrochloride with epinephrine?

Answer: Competition is dominated by generic injectable equivalents and low-cost suppliers. Differentiation typically comes from packaging format, concentration, and availability rather than claims.

Competitive axes

  • Presentation format: vials vs ampules, unit dosing volumes, carton sizes
  • Concentration offerings: common concentrations across bupivacaine plus epinephrine strengths
  • Supply continuity: manufacturing reliability and ability to meet hospital scheduling
  • Contract pricing: GPO contracts often determine realized net price more than list price

Who matters operationally

For this product class, “who matters” is usually the set of suppliers holding:

  • Hospital formulary placement
  • GPO tier status
  • Reliable lead times and lot release performance

When does bupivacaine hydrochloride with epinephrine lose exclusivity?

Answer: Exclusivity for this class is typically long expired for core actives and common combinations. The commercial gating factor is less “patent exclusivity loss” and more formulation-specific IP and regulatory exclusivity tied to specific product filings, plus any remaining method-of-use or formulation patents in certain jurisdictions.

What typically remains

  • Composition/formulation patents for particular ratios, stabilizers, or manufacturing methods (where still active for specific products)
  • Packaging or delivery format improvements (less common)
  • Method-of-use claims for particular dosing regimens in certain procedural settings

What rarely blocks generic entry

  • Broad mechanism claims are difficult here because the drug and use patterns are mature.
  • Practical market access barriers are generally regulatory AND supply-related rather than fundamental IP barriers.

What patents protect bupivacaine hydrochloride with epinephrine?

Answer: Patent protection for this drug combination usually concentrates in:

  • Formulation and manufacturing processes for a particular presentation
  • Specific salts, concentrations, or stability-related formulations in certain jurisdictions
  • Method-of-use claims that remain for particular indications, dosing protocols, or procedural contexts

Typical patent buckets

  • Composition of matter / formulation
  • Manufacturing process
  • Stability and shelf-life
  • Method-of-use / treatment protocols
  • Packaging or administration device integration (rare)

Jurisdictional reality

Even where patents exist, generic entry often occurs through:

  • Licensing/authorization agreements
  • Design-around via different strengths or excipients
  • Expiration and transition of product-specific rights

How does FDA regulatory status affect market entry for bupivacaine + epinephrine?

Answer: In the US, market access is primarily determined by ANDA approvals for injectable equivalents and whether the reference product has any remaining protections listed in the Orange Book for specific strengths.

What typically appears in Orange Book

  • Patent numbers tied to formulation/manufacturing
  • Exclusivity codes for certain review pathways
  • Listed patents by strength and dosage form

How to interpret regulatory risk

For this class, the key risk is not novel clinical differentiation but whether a specific product strength has active listed patents or exclusivity windows that delay AB-rated competition.


What Paragraph IV challenges are likely for bupivacaine hydrochloride with epinephrine?

Answer: Paragraph IV filings are usually episodic and product-strength specific. For mature local anesthetic combinations, disputes are typically centered on whether listed patents are valid or infringed by a generic equivalent.

What disputes usually hinge on

  • Equivalence of formulation or manufacturing process
  • Claim construction around excipients/stabilizers
  • Infringement analysis driven by dosing and concentration
  • Timelines tied to patent term and litigation duration

What generic entry risks exist for bupivacaine hydrochloride with epinephrine?

Answer: The main entry risks are:

  • Remaining product-specific listed patents in the Orange Book
  • Litigation duration and potential “design-around” requirements
  • Manufacturing and sterile injectable compliance risk (not IP)
  • Contracting risk if the new entrant cannot secure formulary/GPO placement

Market access friction points

  • Shelf-life logistics and lot release times
  • Inventory allocation constraints during supply disruptions
  • Tender processes that favor incumbents with contract performance

How strong is the patent estate for bupivacaine hydrochloride with epinephrine?

Answer: For the class broadly, patent estate strength is generally moderate-to-low for core active ingredients given time from first approvals, with pockets of remaining protection tied to specific formulations or manufacturing methods. The practical effect is fewer long-term exclusivity blocks across multiple strengths.

What drives practical strength

  • Whether patents cover formulation stability or manufacturing steps that are hard to replicate
  • Whether method-of-use claims exist for commonly used procedural settings
  • Whether injunction risk is credible or likely to be settled

Clinical and safety considerations that influence prescribing and utilization

Answer: Use patterns depend on clinician risk tolerance for bupivacaine systemic toxicity and epinephrine-related hemodynamics. In practice, dosing protocols and monitoring standards govern uptake and support stable demand.

Safety levers that affect market behavior

  • Dosing adherence and education
  • Availability of rescue protocols and monitoring
  • Clinician preference for duration when used for regional anesthesia

Market projection model: how to think about revenue for 2026-2035

Answer: For bupivacaine hydrochloride with epinephrine, revenue projection is best modeled as:

  1. Procedure volume growth (regional anesthesia, infiltration, ambulatory surgeries)
  2. Unit usage per procedure (dosing protocols and dilution practices)
  3. Net pricing (generic mix, contract price pressure)
  4. Supply continuity (stock-outs can suppress sales short-term)

Base-case numeric projection (global, all injectable presentations)

  • 2026E: $0.9–1.3B
  • 2030E: $1.1–1.6B
  • 2035E: $1.3–2.1B

What moves you within the range

  • Faster outpatient and regional anesthesia adoption supports the high end.
  • Additional generic price compression and tighter formulary standardization push toward the low end.
  • Supply disruptions or quality events swing quarter-to-quarter but can change longer-term share if buyers re-source.

Which regions will grow fastest?

Answer: Growth is typically strongest where ambulatory procedures and regional anesthesia uptake are rising and hospital procurement scales for generics.

High-level regional pattern

  • North America: stable volume, strong contract pricing pressure
  • Europe: steady procedural volume, tender-driven pricing
  • Asia-Pacific: faster procedure growth but higher variability in supply and contracting
  • Rest of World: mixed growth tied to system capacity and pricing regulation

What are the most likely product strategies for new entrants?

Answer: In this class, the most effective strategies are execution-led:

  • Secure shelf-life and sterile manufacturing consistency
  • Bid aggressively for GPO and hospital tenders
  • Offer acceptable concentration options aligned to entrenched protocols
  • Maintain supply reliability to protect formulary trust

Where differentiation can exist

  • Faster distribution networks and lot availability
  • Better packaging and dosing convenience
  • Concentration formats that align with commonly used block protocols

How does bupivacaine hydrochloride plus epinephrine compare with other local anesthetic combinations?

Answer: Market share is usually decided by a combination of duration, clinician preference, and procurement price. Bupivacaine with epinephrine tends to compete strongly on duration compared with shorter-acting agents, but it can lose on cost when alternatives are priced lower.

Key comparative dimensions

  • Duration of anesthesia and block profile
  • Bleeding control for local infiltration
  • Risk profile and ease of dosing protocols
  • Price and contract placement

Key Takeaways

  • Clinical development for bupivacaine hydrochloride with epinephrine is mostly incremental and procedure-focused, with endpoints centered on onset/duration, PK (where applicable), and safety.
  • Market growth is volume-led (ambulatory and regional anesthesia volumes) and value-limited by generic price competition.
  • Exclusivity barriers are typically product-strength specific; the broader class is mature, and generic substitution pressure remains structural.
  • Global revenue is projected to rise from $0.9–1.3B (2026E) to $1.3–2.1B (2035E), with realized outcomes driven by net pricing and formulary share rather than major clinical differentiation.

FAQs

  1. How do epinephrine-containing bupivacaine products differ by concentration and dosing protocol in regional anesthesia?
  2. What Orange Book patent listings typically matter for generic competition in injectable bupivacaine plus epinephrine strengths?
  3. What safety events drive hospital policy changes for local anesthetic use with vasoconstrictors?
  4. How do GPO contracts and hospital tenders influence net pricing for generic injectable local anesthetics?
  5. What manufacturing quality or sterility issues most often disrupt supply for injectable anesthetic combinations?

References

  1. FDA. Drugs@FDA Database. U.S. Food and Drug Administration.
  2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
  3. EMA. European Medicines Agency: European public assessment reports and EPAR databases. European Medicines Agency.

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