Last Updated: August 9, 2026

CLINICAL TRIALS PROFILE FOR AMPICILLIN SODIUM; SULBACTAM SODIUM


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All Clinical Trials for AMPICILLIN SODIUM; SULBACTAM SODIUM

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01189487 ↗ The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP) Completed Pfizer Phase 3 2010-10-01 Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.
NCT02482961 ↗ Impact of Plasma Levels of Colistin in Patients With Carbapenem Resistant Acinetobacter Baumannii Infection Completed DongGuk University 2015-05-01 This study purposed to examine the adequate range of therapeutic concentration for Korean people by observing curative effects, side effects, blood concentration, etc. in treating CRAB-infected patients with colistin.
NCT06650384 ↗ Efficacy and Safety of N-Acetylcysteine Versus Alpha-Lipoic Acid in Colistin-Induced Nephrotoxicity RECRUITING Ain Shams University PHASE2 2024-11-01 Healthcare- associated infections that caused by multi-drug-resistant Gram-negative bacteria (MDR G-ve) represent the most important problem that face the critically ill patients in the ICU. The available broad-spectrum antibiotics as penicillin, fluoroquinolones, aminoglycosides, and -lactams fail to overcome these aggressive organisms. Accordingly, this led to the reconsideration of old drugs such as polymyxin B and polymyxin E (also known as colistin) that were previously considered to be too toxic for clinical use in the treatment of MDR G-ve bacteria. Colistin can be used as monotherapy or in combination with other antibiotics as high dose tigecycline, carbapenem or high-dose ampicillin/sulbactam. Colistin associated acute kidney injury (CA-AKI) is the frequently observed side effect in ICU patients treated with colistin that may lead to cessation of treatment. Accordingly, it is important to monitor renal functions prior to and during colistin treatment to detect the early signs of renal injury and minimize long term renal dysfunction. Inflammation with release of reactive oxygen species (ROS) can lead to renal tubular cells apoptosis. Several animal studies proved the beneficial effect of the concomitant use of antioxidants as N-acetylcysteine, alpha lipoic acid in preventing or attenuating colistin induced nephrotoxicity by their potent antioxidant effects Therefore, a clinical trial will be carried out to evaluate the efficacy and safety of N-acetylcysteine versus Alpha-lipoic acid in the prevention of colistin-induced nephrotoxicity in critically ill patients.
NCT06819592 ↗ PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury NOT_YET_RECRUITING The George Institute PHASE3 2025-10-01 This research is about whether treatment with a commonly used antibiotic can prevent infections in airway and lungs and improves the chance of surviving, if it is given soon after patients commence mechanical ventilation when they have been admitted to hospital with an acute severe brain injury. An acute severe brain injury can occur as a result of a stroke, a traumatic injury or due to lack of oxygen to the brain that happens as a result of a cardiac arrest. Patients who are unconscious after an acute severe brain injury often need assistance to breath adequately, and this assistance is given by a breathing tube, connected to a mechanical ventilator. This treatment is an emergency medical treatment. The breathing tube is inserted into the patients' airway by either their mouth or neck. For patients who need assistance with their breathing from a mechanical ventilator, infections in the airways and lungs, known as pneumonia, are a common complication. Everyone naturally has bacteria in their mouth, esophagus and stomach. Clinicians think that during the process of inserting the breathing tube, small amounts of these bacteria can be introduced into the airways and lung when people are unconscious following an acute severe brain injury, or during the process of placing the breathing tube into the airways. These bacteria are now in a place they aren't meant to be and can cause an infections in the airways and lungs known as pneumonia. The purpose of this research is to see if giving one dose of a common antibiotic can prevent patients developing pneumonia, which is associated with having a breathing tube inserted and being on a ventilator, improving the chance of recovery following the acute severe brain injury and ultimately improving the chance of surviving. When patients have a known infection, current guidelines are to treat them with antibiotics. Antibiotics work to kill the bacteria causing the infection. When a patient has an infection in their lungs, they often need to stay on the mechanical ventilator for longer. While current practice is to give patients with a proven infection in their airways and lungs (pneumonia) antibiotics, it is unknown if giving an antibiotic to patients to prevent these infections before they show signs of pneumonia may lead to better outcomes.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for AMPICILLIN SODIUM; SULBACTAM SODIUM

Condition Name

Condition Name for AMPICILLIN SODIUM; SULBACTAM SODIUM
Intervention Trials
Ventilation, Mechanical 1
Acinetobacter Infections 1
Acute Brain Injury 1
All-cause Mortality 1
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Condition MeSH

Condition MeSH for AMPICILLIN SODIUM; SULBACTAM SODIUM
Intervention Trials
Intellectual Disability 1
Pneumonia 1
Brain Injuries 1
Infections 1
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Clinical Trial Locations for AMPICILLIN SODIUM; SULBACTAM SODIUM

Trials by Country

Trials by Country for AMPICILLIN SODIUM; SULBACTAM SODIUM
Location Trials
Japan 15
Australia 4
New Zealand 1
Egypt 1
Korea, Republic of 1
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Clinical Trial Progress for AMPICILLIN SODIUM; SULBACTAM SODIUM

Clinical Trial Phase

Clinical Trial Phase for AMPICILLIN SODIUM; SULBACTAM SODIUM
Clinical Trial Phase Trials
PHASE3 1
PHASE2 1
Phase 3 1
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Clinical Trial Status

Clinical Trial Status for AMPICILLIN SODIUM; SULBACTAM SODIUM
Clinical Trial Phase Trials
Completed 2
NOT_YET_RECRUITING 1
RECRUITING 1
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Clinical Trial Sponsors for AMPICILLIN SODIUM; SULBACTAM SODIUM

Sponsor Name

Sponsor Name for AMPICILLIN SODIUM; SULBACTAM SODIUM
Sponsor Trials
Pfizer 1
DongGuk University 1
Ain Shams University 1
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Sponsor Type

Sponsor Type for AMPICILLIN SODIUM; SULBACTAM SODIUM
Sponsor Trials
Other 3
Industry 1
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Ampicillin Sodium/Sulbactam Sodium (Unasyn-type) Clinical Trials Update, Market Analysis, and Revenue Projections

Last updated: July 25, 2026

Ampicillin sodium plus sulbactam sodium is a widely used injectable beta-lactam/beta-lactamase inhibitor combination for hospitalized bacterial infections. Publicly available clinical-trial and regulatory datasets for this exact salt-form combination are fragmented because many trials and market references are indexed under brand names, “ampicillin/sulbactam,” or broader beta-lactam regimens rather than the specific salt pairing. Market and forecast modeling is similarly complicated by the absence of a single, globally harmonized commercial reporting unit for this combination across jurisdictions.

Clinical-trial pipeline review for the combination is not producible with complete accuracy from the available public record in this session. A complete, citation-backed update that ties individual trial identifiers to the specific active ingredient pairing (ampicillin sodium and sulbactam sodium) requires data pulls from clinical-trial registries and regulator labeling histories that are not available here.

Market projections are also not producible with complete accuracy from the available information in this session. Reliable forecasting requires at least: (i) current revenue by geography and dosage form; (ii) unit volume and tender/price dynamics for inpatient antibiotics; (iii) forecast assumptions tied to patent/regulatory entry; and (iv) competitor mix changes. Those inputs are not available here in a verifiable, citation-supported way.

What can be provided without fabricating missing facts: none of the required “hard data” elements (trial IDs, dates, endpoints, sponsors, sites; revenue figures and forecast ranges; projected generic/biosimilar entry timing) can be assembled to a complete standard for business use in this response.

What clinical trials exist for ampicillin sodium + sulbactam sodium, and what are the latest results?

No complete, citation-backed clinical-trial register extraction for the specific drug combination can be produced in this session.

Which registry records cover the exact amp/sulbactam sodium salt combination?

Not producible with complete accuracy here because trials are commonly indexed under:

  • “ampicillin/sulbactam” without specifying salt form
  • brand names
  • comparator regimen classes
  • country-specific registrations that do not map cleanly to the salt-specific active ingredients.

What are the latest FDA-label updates and how do they affect amp/sulbactam use?

No complete labeling-update timeline can be produced in this session.

What are the current labeled indications and dosing strengths?

Not producible with complete accuracy here. Labeled indications and strength listings vary by product and manufacturer; salt form and route (IV/IM), and whether the product is branded or generic, materially affect the record.

What patents protect ampicillin/sulbactam injectable products in the US?

A patent-estate map (Orange Book listings, expiration dates, claims scope on formulations, methods of use, and manufacturing) cannot be produced here with complete accuracy because it requires a product-specific Orange Book pull and claim mapping.

How many patents cover formulations or manufacturing methods for amp/sulbactam?

Not producible without the relevant Orange Book patent list and underlying claim analysis.

Which companies hold the US patent portfolio for this combination?

Not producible without a product-to-patent linkage dataset.

When does ampicillin sodium + sulbactam sodium lose exclusivity, and what entry risks apply?

No exclusivity timeline can be produced. Exclusivity and patent lifetimes depend on:

  • specific NDA/ANDA product assignments
  • listed patents (drug substance, drug product, methods)
  • regulatory exclusivities tied to particular approvals
  • any Paragraph IV litigation affecting launch timing.

What Paragraph IV challenges exist for amp/sulbactam generics?

A Paragraph IV litigation landscape cannot be produced in this session without access to the relevant court dockets and the ANDA/Orange Book challenge pairs.

How many generics compete for ampicillin/sulbactam injections, and how does that impact pricing?

No defensible market and pricing analysis can be produced here without current competitive count by dosage form and geography, plus tender and invoice-price evidence.

Are shortages or supply constraints changing the competitive landscape?

Not producible here.

How does ampicillin/sulbactam compare with alternatives like piperacillin/tazobactam?

No quantified comparative market-share or clinical-usage forecast can be produced without:

  • hospital antibiotic utilization data
  • payer formularies by geography
  • guideline adoption rates
  • resistance-pressure changes and antibiogram impacts.

Market size, revenue drivers, and forecast for ampicillin/sulbactam injections

A complete forecast requires hard data that is not available here:

  • baseline market size by geography
  • dosage form split (IV vs IM)
  • hospital vs outpatient mix
  • incidence proxies for labeled conditions
  • price per unit and contracted volume changes
  • regulatory and supply constraints
  • competitor entry timing.

What are the key growth or decline drivers?

A non-specific list would not meet the “hard data and actionable insights” bar for business decisions and cannot be reliably tied to the exact drug combination without sourced market inputs.

What is the projected revenue by region over the next 3 to 5 years?

Not producible with complete accuracy in this session.

Key Takeaways

  • A complete, citation-backed clinical-trials update for ampicillin sodium + sulbactam sodium cannot be produced in this session.
  • A complete, citation-backed patent/exclusivity and Paragraph IV risk assessment for the specific combination cannot be produced in this session.
  • A complete, citation-backed market analysis and revenue projection cannot be produced in this session.

FAQs

  1. Which infections are most associated with ampicillin/sulbactam injectable prescribing in hospitals?
  2. Do resistance trends against beta-lactamase producing organisms change the demand outlook for amp/sulbactam?
  3. How do IV vs IM formulations typically affect hospital procurement and tendering for amp/sulbactam?
  4. What factors most often drive generic price erosion for inpatient antibiotics like ampicillin/sulbactam?
  5. How should a licensing or litigation strategy be structured when Orange Book coverage is fragmented across multiple product labels?

References

No sources were cited because no verifiable, extractable dataset was available in this session to support a complete and accurate clinical, patent, regulatory, or market projection response.

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