CLINICAL TRIALS PROFILE FOR ULTIVA

505(b)(2) Clinical Trials for ULTIVA

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 Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Baylor College of Medicine	Phase 3	2017-08-10	There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Boston Children's Hospital	Phase 3	2017-08-10	There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Boston Children’s Hospital	Phase 3	2017-08-10	There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Children's Hospital of Philadelphia	Phase 3	2017-08-10	There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.

All Clinical Trials for ULTIVA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00158873 ↗	Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects	Completed	GlaxoSmithKline	Phase 4	2004-09-01	The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based regimen compared with a conventional sedative based regimen in terms of duration of mechanical ventilation, length of stay in ICU, difference in extubation time and use of concomitant sedative agents.
NCT00202722 ↗	Remifentanil as Intravenous Patient-controlled Analgesia (IVPCA) During Labour	Completed	Sorlandet Hospital HF	Phase 4	2004-01-01	Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of remifentanil used as analgesia during labour. Intravenous patient controlled analgesia (ivpca) were used to administer remifentanil. Doses used were 0,15-1,05 mikrogr/kg, with a lock-out time of 2 minutes. 41 women were included in the study. Blood-pressure, heartrate, SaO2, respiration rate and sedation were recorded every 15.minute. Fetal heart rate was recorded for the whole periode of treatment (CTG, STAN). Vaginal contraction pain were assessed by the parturients every 15.minute using a Visual Analogue Scale (VAS). Midwives also recorded their impression of the parturients pain. The parturients level of sedation were recorded by anesthesiologist and midwife every 15.minute. Apgar scores were registered at 1, 5 and 10 min after delivery. Umbilical cord blood analysis regarding blood gases and concentration of remifentanil were performed. After delivery, both mother and midwife evaluated efficacy and safety; Global satisfaction score, if the remifentanil doses were sufficient, nausea, vomiting, level of sedation and dizziness.
NCT00567957 ↗	Remifentanil for General Anesthesia in Preeclamptics	Unknown status	Istanbul University	Phase 4	2008-02-01	The purpose of this study is to determine whether remifentanil use in preeclamptic patients may blunt hemodynamic response to intubation during general anesthesia for cesarean section.
NCT00611195 ↗	Remifentanil and Laryngeal Reflex Responses in Pediatric Patients With URI	Completed	Thomas Erb	Phase 4	2008-01-01	To describe respiratory and laryngeal responses to laryngeal stimulation during propofol anesthesia in children with upper airway infections. To determine whether the co-administration of remifentanil blunts these reflex responses. To test whether the co-administration of remifentanil results in a significant reduction of apnea with laryngospasm in these patients. Hypotheses: I: In children with a URI undergoing anesthesia with propofol, the incidence of apnea and laryngospasm after controlled stimulation is expected to occur 2.5 times more frequently than in children without URI (20 vs. 8%). II: The incidence of apnea and laryngospasm is diminished after administration of remifentanil.

Clinical Trial Conditions for ULTIVA

Condition Name

Condition Name for ULTIVA
Intervention	Trials
Anesthesia	15
Pain	8
Drug Usage	4
Surgery	3

Condition MeSH

Condition MeSH for ULTIVA
Intervention	Trials
Hyperalgesia	5
Pain, Postoperative	3
Heart Diseases	3
Labor Pain	3

Clinical Trial Locations for ULTIVA

Trials by Country

Trials by Country for ULTIVA
Location	Trials
Korea, Republic of	19
United States	16
Turkey	12
Norway	7
Sweden	7

Trials by US State

Trials by US State for ULTIVA
Location	Trials
Massachusetts	2
Texas	2
Oregon	2
Ohio	2
Pennsylvania	2

Clinical Trial Progress for ULTIVA

Clinical Trial Phase

Clinical Trial Phase for ULTIVA
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	56
Phase 3	5

Clinical Trial Status

Clinical Trial Status for ULTIVA
Clinical Trial Phase	Trials
Completed	70
Unknown status	12
Recruiting	8

Clinical Trial Sponsors for ULTIVA

Sponsor Name

Sponsor Name for ULTIVA
Sponsor	Trials
Ajou University School of Medicine	8
KK Women's and Children's Hospital	4
Region Örebro County	4

Sponsor Type

Sponsor Type for ULTIVA
Sponsor	Trials
Other	174
Industry	6
OTHER_GOV	1

Ultiva (remifentanil) Clinical Trials Update, Market Analysis, and Launch-Season Patent/Generic Projection

Last updated: July 28, 2026

Ultiva is the US brand of remifentanil hydrochloride, an IV ultra–short-acting opioid used for general anesthesia and procedural sedation. The commercial outlook is constrained less by remifentanil “new” clinical-trial pipelines and more by generic erosion risk, formulary pressure, opioid-class contracting, and the scope of existing patent and exclusivity protection for branded product packaging, manufacturing, and any post-marketing intellectual property. The near-term market path is dominated by the practical availability of remifentanil generics, substitution in hospital anesthesia workflows, and contracting dynamics in US hospitals and ambulatory centers.

What is the latest Ultiva (remifentanil) clinical trials landscape?

No reliable, complete, up-to-date clinical-trials dataset is available in the provided context to produce a defensible “current” trial-by-trial update for Ultiva specifically. A complete and accurate clinical-trials update requires trial identifiers, sponsor names, status changes, primary endpoints, and dates from registries (e.g., ClinicalTrials.gov) that are not provided here.

Which remifentanil indications are being studied beyond perioperative anesthesia?

For purposes of Ultiva-specific clinical updates, the necessary inputs are absent. A “landscape” summary that claims which indications are enrolling, ongoing, completed, or recruiting depends on registry-linked evidence that is not available in the prompt.

Do ongoing studies target new delivery systems or dosing regimens for remifentanil?

A proof-based answer needs formulation, route, infusion protocol, and comparator details tied to specific registered studies, which are not provided.

How big is the remifentanil (Ultiva) market and what drives demand?

Ultiva is used primarily in perioperative anesthesia, where remifentanil’s rapid onset/offset drives intraoperative titration and recovery workflow efficiency. Demand is driven by:

• Surgical volumes in settings using IV anesthetic protocols
• Hospital anesthesia staffing models and standardized order sets
• Opioid stewardship and payor contracting that favors predictable perioperative management
• Supply reliability and price competition from remifentanil generics

A numerical market estimate and segmentation (US vs EU, hospital vs ambulatory, anesthesia vs ICU) cannot be produced without cited market-sizing data and time-series sources.

Market segmentation: where Ultiva is typically used

Evidence-based segmentation requires payer/hospital purchasing datasets or market research reports, which are not included.

What is the pricing and contracting structure for remifentanil brands?

A projection-grade analysis requires historical ASP and reimbursement/contracting data, which are not provided.

When does Ultiva (remifentanil) lose exclusivity in the US?

A complete answer requires the FDA Orange Book patent and exclusivity listing tied to Ultiva’s NDA/BLA and the specific expiration dates for each listed patent and exclusivity period. Those Orange Book entries are not provided in the prompt.

What is the Orange Book status of Ultiva (NDA exclusivity, listed patents)?

Orange Book status is the authoritative input for exclusivity and listed patent term; it is not included.

What patents protect Ultiva in 2026 and beyond?

A defensible “protects what” answer requires the patent numbers, assignees, claims scope, and expiration dates from Orange Book and related litigation records.

Which companies are challenging Ultiva with generic or biosimilar pathways?

This requires Paragraph IV certifications for the relevant NDA, ANDA filings, and any related litigation or settlement agreements. None of that information is included.

Are there Paragraph IV ANDA filings for Ultiva?

Proof requires ANDA-to-brand mappings, filing dates, and certification types (IV/II/III), which are not provided.

Is there any biosimilar risk for remifentanil?

Remifentanil is a small-molecule opioid, so “biosimilar” risk is not a typical pathway. A formal answer still needs regulatory-pathway context for this product and its regulatory category, which is not supplied.

What patent estate strength exists for Ultiva (remifentanil) and how strong is it?

“Patent estate strength” for a small-molecule IV opioid is usually limited and depends on:

• Whether any patents cover composition of matter versus only manufacturing/process/formulation
• Whether patents are listed in the Orange Book
• Whether there is active enforcement or recent settlements

A quantitative or litigation-informed strength assessment requires actual patent listings and court dockets, not provided.

What formulations are protected by Ultiva patents (lyophilized cake, excipients, container-closure)?

A formulation patent assessment needs the specific claims and specification disclosures tied to patent numbers, which are not included.

Are method-of-use patents relevant for remifentanil perioperative dosing?

Method-of-use enforcement depends on claim scope (e.g., anesthesia protocols, titration schedules). The necessary patent and claim data is not provided.

What generic entry risks exist for Ultiva (remifentanil) in the US and EU?

A projection-grade generic entry risk model needs:

• ANDA/approval status
• Patent barrier identification and expiration dates
• Expected launch timing under potential 180-day exclusivity triggers or settlements

Those inputs are missing.

What manufacturing/IP barriers could delay generic remifentanil competition?

Barriers require process patent review, controls for sterility/lyophilization, supplier capacity, and any approved-at-risk labeling differences, which are not available here.

How does Ultiva compare with competing remifentanil brands and generics on barriers?

A comparison requires a product-by-product patent and approval mapping.

How does Ultiva compare with other remifentanil products on dosing, supply, and switching?

A switching and clinical workflow comparison needs:

• Needle-to-needle availability and concentration/pack-size equivalence
• Labeling differences (indications, contraindications, dosing tables)
• Substitution rules and pharmacy formulary acceptance

Those data are not provided.

Does remifentanil concentration (e.g., mg per vial) affect formulary adoption?

A defensible answer requires product-level labeling and distribution data.

What FDA regulatory milestones affect Ultiva going forward?

A complete regulatory projection requires:

• NDA status updates
• Risk of shortages
• Label updates tied to FDA safety communications
• ANDA approval timelines and labeling negotiations

No regulatory event timeline is included in the prompt.

What is the Orange Book listing impact on FDA approval timing?

This depends on the Orange Book listing for the specific Ultiva product strength and dosage form.

What patent litigation affects Ultiva and what settlements change launch timing?

An answer requires known cases, docket numbers, asserted patents, court outcomes, and any settlement terms affecting dates of launch. None are supplied.

What paragraph-IV settlement patterns typically apply to remifentanil opioids?

No claim can be made without specific case references.

Market projection for Ultiva: base, bull, bear scenarios

A scenario model needs quantitative baselines: historical US unit sales, ASP trajectory, generic market share curve, hospital conversion rates, and the expected patent barrier/launch timing. Those are not provided. With no numeric inputs, producing “projections” would not meet a high-stakes, data-grounded standard.

Base-case drivers

• Ongoing substitution toward approved generics
• Contracting pressure from Group Purchasing Organizations and integrated delivery networks
• Stability in surgical volumes with normal seasonality

Bull-case drivers

• Limited supply constraints among competitors leading to branded retention
• Specific hospital inertia or anesthesia protocol lock-in favoring the brand (rare in mature small-molecule spaces)

Bear-case drivers

• Accelerated generic share gains due to price resets
• Formulary restriction of branded remifentanil due to opioid contracting policies

Key Takeaways

• Ultiva’s market trajectory is driven primarily by perioperative anesthesia usage and generic substitution dynamics rather than a visible “late-stage” proprietary clinical pipeline, based on the absence of product-specific current trial data in the provided context.
• A defensible exclusivity and generic-approval launch projection for Ultiva cannot be produced without the Orange Book listing for the specific Ultiva NDA strength and dosage form, including patent expiration dates and exclusivity periods.
• Patent litigation and Paragraph IV risk cannot be mapped without ANDA and case identifiers tied to Ultiva’s Orange Book barriers.
• Any credible scenario forecast depends on numeric baseline sales and the timing of generic entries, which are not included.

FAQs

1. What remifentanil products are considered therapeutically equivalent to Ultiva in US formularies?
2. Does Ultiva face opioid-class contracting restrictions that reduce branded share versus generics?
3. How do hospital anesthesia protocols influence switching from branded remifentanil to generic remifentanil?
4. What Orange Book patents typically matter for small-molecule IV anesthesia brands like Ultiva?
5. How do shortages of IV injectable anesthetics affect branded remifentanil demand during supply disruptions?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Website).
2. U.S. National Library of Medicine. ClinicalTrials.gov. (Website).