CLINICAL TRIALS PROFILE FOR SURVANTA

All Clinical Trials for SURVANTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005774 ↗	Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants	Terminated	National Center for Research Resources (NCRR)	Phase 3	2000-05-01	Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
NCT00005774 ↗	Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants	Terminated	NICHD Neonatal Research Network	Phase 3	2000-05-01	Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
NCT00146497 ↗	Cytokine Change in Bronchoalveolar Lavage Fluid After Early Budesonide-Surfactant Treatment in Premature Infants	Terminated	China Medical University Hospital	Phase 4	2004-08-01	Pulmonary inflammation plays an important role in the development of chronic lung disease (CLD) in preterm infants. This inflammation occurs very early in postnatal life. Any therapy that could be beneficial in preventing CLD should be started very early. The investigators' previous double-blind study has shown that early (< 12 hours) postnatal use of intravenous dexamethasone for 4 weeks significantly suppressed pulmonary inflammation and significantly reduced the incidence of CLD. However, the use of dexamethasone was associated with increased incidence of infection and sepsis. Their follow-up study also suggested an increase in the incidence of psychomotor anomalies. As compared to intravenous administration, endotracheal instillation will provide more local anti-inflammatory effects and less systemic side effects. Infants will be eligible for the study if their birth weight (BW) is < 1500 gm and if they had severe respiratory distress syndrome (RDS) requiring mechanical ventilation shortly after birth. After informed consent is obtained, the infant will be randomly assigned depending on the condition of the infant. The primary outcome is the change in cytokines (interleukin-6, 8, 10 and TNF-α) levels in BAL fluid. Chronic lung disease (CLD) was judged at 36 postmenstrual weeks. Infants in the study group (S/B group) received surfactant (Survanta®, Abbott Laboratories, North Chicago, IL; 100 mg or 4 mL/kg/dose) and Budesonide (Pulmicort®, AstraZeneca Pty Ltd., Australia; 0.5 mg or 1mL/kg/dose), while those in the control group (S group) received surfactant (Survanta® Abbott, 100 mg/kg/dose) and saline (1mL/kg).
NCT00767039 ↗	Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants	Terminated	Dey LP	Phase 4	2005-01-01	Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.

Clinical Trial Conditions for SURVANTA

Condition Name

Condition Name for SURVANTA
Intervention	Trials
Respiratory Distress Syndrome	7
Infant, Newborn	2
Infant, Premature	1
Infant, Small for Gestational Age	1

Condition MeSH

Condition MeSH for SURVANTA
Intervention	Trials
Respiratory Distress Syndrome, Newborn	9
Respiratory Distress Syndrome, Adult	9
Respiratory Distress Syndrome	9
Syndrome	4

Clinical Trial Locations for SURVANTA

Trials by Country

Trials by Country for SURVANTA
Location	Trials
United States	27
Taiwan	2
Turkey	1
China	1

Trials by US State

Trials by US State for SURVANTA
Location	Trials
Michigan	4
California	2
Texas	2
Tennessee	2
Ohio	2

Clinical Trial Progress for SURVANTA

Clinical Trial Phase

Clinical Trial Phase for SURVANTA
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for SURVANTA
Clinical Trial Phase	Trials
Completed	3
Terminated	3
Unknown status	3

Clinical Trial Sponsors for SURVANTA

Sponsor Name

Sponsor Name for SURVANTA
Sponsor	Trials
NICHD Neonatal Research Network	2
China Medical University Hospital	2
King Edward Memorial Hospital, Pune	1

Sponsor Type

Sponsor Type for SURVANTA
Sponsor	Trials
Other	31
Industry	2
NIH	1

Last updated: July 28, 2026

Survanta (calfactant) clinical trials update, market analysis, and projection: sales outlook, generic/biosimilar risk, and patent-driven timelines

Survanta (calfactant) is a small-footprint, hospital-administered surfactant for neonatal respiratory distress syndrome (RDS) that remains relevant primarily where NICU formularies still favor animal-derived bovine lung surfactant. A recent, full-cycle view of market and clinical activity is constrained by limited public trial visibility and the absence of a current, centralized FDA/Orange Book-based risk map in the provided materials.

What is Survanta and what clinical trial updates matter for neonatal RDS?

Survanta mechanism and labeled use

Survanta is an exogenous pulmonary surfactant indicated for neonatal RDS in premature infants. It is administered intratracheally via endotracheal tube in a NICU setting, typically following standard stabilization protocols.

Where do new clinical trials typically show up for Survanta-like surfactants?

For neonatal RDS surfactants, new trials most often target:

• comparative efficacy vs. other intratracheal surfactants (poractant alfa, beractant, etc.)
• dosing regimen optimizations
• health-economic outcomes in NICUs (ventilation duration, oxygen requirement, NICU length of stay)
• subpopulations such as extremely low birth weight or late-preterm cohorts (depending on jurisdiction and label)

Clinical trials update

No new, contemporaneous, regulator-registered efficacy trials with Survanta-specific endpoints are confirmed in the provided information. Practically, this means current competitive and prescribing dynamics are driven more by formulary decisions, supply continuity, and payer/contracting than by fresh phase 3 readouts.

Is Survanta still active in clinical development or only in post-marketing use?

Development-stage reality

Survanta functions as an established product with ongoing post-marketing pharmacovigilance and usage. In most markets, “clinical update” activity for established surfactants is seen through:

• label maintenance (safety updates)
• manufacturing changes and comparability lots
• real-world evidence studies in NICUs

What would count as a high-impact update

For Survanta specifically, the only changes that tend to move the needle are:

• new randomized head-to-head evidence strong enough to alter guideline recommendations
• changes in dosing or administration that reduce complications or improve oxygen weaning
• supply and manufacturing reliability issues that alter availability

Those categories are not evidenced in the provided material.

What is the Survanta market size today and what drives demand?

Demand drivers in NICUs

Survanta demand is mainly driven by:

• preterm birth incidence (regional)
• NICU capacity and throughput
• guideline alignment with specific surfactant products
• procurement behavior (GPO and distributor contracts)
• clinician preference based on historical outcomes and familiarity

Hospital formulary stickiness

Surfactants are low-frequency per patient but high-value per case. Formularies often remain stable for extended periods because switching can require:

• staff retraining
• protocol revisions
• internal auditing of outcomes
• inventory and procurement reconfiguration

Competitive substitution

Even when comparable products exist, substitution is limited by local practice:

• some systems prefer poractant alfa or beractant for perceived dosing convenience or outcomes
• others remain with calfactant based on contract and historic performance

How does Survanta compare with poractant alfa and beractant on market competitiveness?

Product positioning

• Survanta (calfactant) is an established animal-derived surfactant used for intratracheal instillation.
• Poractant alfa and beractant are the main alternative intratracheal surfactants in many settings.

Key substitution levers

The market trade-off typically includes:

• dosing schedule convenience
• unit pricing and purchasing agreements
• perceived clinical workflow fit in NICUs
• supply reliability during peak seasonal preterm admissions

A direct, up-to-date pricing and volume comparison is not contained in the provided materials, so a quantified market-share split cannot be produced here.

When does Survanta lose exclusivity and what is the patent expiration timeline?

Exclusivity and patent-driven risk in established surfactants

For an older, off-patent hospital product, market exclusivity is typically limited to:

• specific formulation/manufacturing process improvements
• method-of-use niches (if any remain protected)
• Orange Book-listed listed patents tied to specific dosage form and/or labeling elements

A complete patent expiration and exclusivity timeline for Survanta cannot be constructed without Orange Book and patent-list data, which are not provided.

What generic entry risks exist for Survanta in the US?

US generic pathway considerations

For complex biologic-like or surfactant drug products, generic entry is constrained by:

• manufacturing controls and characterization
• process robustness and comparability
• regulatory pathway feasibility (depending on whether the product is treated as a drug vs biologic under applicable statutes and guidances)

A Paragraph IV-specific risk assessment cannot be produced without the current patent list and any FDA-accepted ANDA history.

How strong is the Survanta patent estate and what patents protect formulations or methods?

What to look for in a patent estate for surfactants

Patent coverage usually clusters around:

• composition and formulation elements
• methods of producing surfactant preparations
• methods of use (indication-specific, dosing-specific)
• device and administration-related claims (less common for legacy products)

A strength score with specific patent numbers cannot be produced without the patent inventory and remaining claims, which are not included.

What is the Orange Book status of Survanta and how many patents are listed?

Orange Book status

An Orange Book count, expiration dates, and patent type breakdown (drug substance, drug product, method of use) are not available in the provided information. Without that, no authoritative listing summary can be generated.

What FDA regulatory actions affect Survanta availability (shortages, recalls, manufacturing issues)?

Availability impact pathways

For NICU products, availability shocks affect prescribing even when clinical equivalence exists. The most common regulatory/market events that move demand include:

• manufacturing site constraints
• quality system actions
• distribution limitations
• recalls that temporarily reduce inventory

No such events are included in the provided materials, so an actionable timeline cannot be built.

What is the current competitive landscape for intratracheal surfactants in neonatal RDS?

Competitive set

The practical competitive landscape includes:

• other intratracheal surfactants (poractant alfa, beractant, and similar products depending on geography)
• alternative strategies such as less invasive surfactant administration (LISA) protocols in some settings, which change administration workflow rather than only drug choice

Market share dynamics

Market share is shaped by:

• clinician protocol preferences
• payer contract tenders
• hospital purchasing cycles
• supply continuity and lead times

A quantified landscape is not possible with the provided inputs.

How should investors model Survanta revenue projections and what scenarios matter?

Model structure for a hospital surfactant

A defensible projection model typically uses:

• incidence of eligible preterm RDS cases (by geography)
• proportion treated with intratracheal surfactant
• market share within treated population by product
• average selling price net of rebates/contract concessions
• annual treatment frequency per patient (dose multiplicity depends on protocol)

Scenario drivers

Three scenarios dominate:

1. Status quo: stable hospital formulary share and procurement cycles.
2. Formulary switch: contract award to a competitor based on pricing or supply.
3. Supply disruption: reduced availability changes short-term sales and may accelerate switching.

Quantitative base-case, bull, and bear projections cannot be produced without sales history, unit volumes, and price data.

Clinical trial and market projection summary

Survanta remains an established NICU surfactant with clinical relevance tied to hospital protocols rather than new phase 2/3 breakthroughs. Current competitive pressures are more likely to come from contracting, supply stability, and preference drift among NICUs than from imminent evidence changes. A rigorous patent-and-exclusivity calendar, Orange Book inventory count, and generic entry probability cannot be stated from the provided information.

Key Takeaways

• Survanta is used for neonatal RDS and remains a hospital-formulary-dependent product.
• Clinical development momentum appears limited in the provided materials; meaningful updates would likely be post-marketing or protocol-level rather than phase 3 efficacy readouts.
• Market dynamics are primarily NICU incidence, procurement contracts, and substitution among competing intratracheal surfactants.
• Patent, Orange Book, and generic-entry timelines cannot be quantified without Orange Book and patent-list details.

FAQs

1. How do NICU formularies typically decide between calfactant and poractant alfa?
2. What factors most affect intratracheal surfactant utilization rates in extremely preterm infants?
3. How do supply constraints for neonatal respiratory products shift hospital prescribing behavior?
4. What regulatory pathway issues can slow generic competition for surfactant drug products?
5. How do dosing protocol differences change total units used per patient for Survanta?

References

1. No citable sources were provided in the prompt.