INFASURF Drug Profile

« Back to Dashboard

Summary for Tradename: INFASURF

High Confidence Patents:	0
Applicants:	1
BLAs:	2
Drug Prices:	Drug price information for INFASURF

See drug prices for INFASURF

Pharmacology for INFASURF

Mechanism of Action	Surfactant Activity
Physiological Effect	Alveolar Surface Tension Reduction
Established Pharmacologic Class	Surfactant

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for INFASURF Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for INFASURF Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for INFASURF Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521		2028-08-19	Patent claims search
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521		2029-04-23	Patent claims search
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521		2027-11-02	Patent claims search
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521		2025-07-27	Patent claims search
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521		2032-02-22	Patent claims search

INFASURF Market Dynamics and Financial Trajectory

Last updated: November 1, 2026

INFASURF, the bovine-derived pulmonary surfactant calfactant, is a mature neonatal intensive-care product used to prevent and treat respiratory distress syndrome in premature infants. Its commercial position is supported by clinical familiarity, hospital protocols, and manufacturing complexity rather than meaningful remaining regulatory exclusivity. The primary competitive threats are Chiesi’s CUROSURF and Chiesi’s SURVANTA, along with hospital purchasing pressure and declining preterm birth rates in some developed markets.

Standalone INFASURF revenue is not publicly disclosed. Its financial trajectory is therefore best assessed through product maturity, hospital utilization, competitive share, pricing conditions, ownership and licensing disclosures, and the absence of publicly visible biosimilar or generic entry.

What is INFASURF and how does it work?

INFASURF is an intratracheal suspension containing calfactant, a pulmonary surfactant derived from bovine lung extract. It replaces deficient or inactive endogenous surfactant in premature infants with respiratory distress syndrome.

The product is administered directly into the trachea through an endotracheal tube. Its principal clinical uses are:

• Prevention of respiratory distress syndrome in premature infants at high risk.
• Rescue treatment of premature infants who develop respiratory distress syndrome.

The FDA-approved dosage is 3 mL/kg of birth weight for prophylaxis or treatment, with additional doses permitted under the prescribing information when clinically necessary.[1]

Attribute	INFASURF
Active ingredient	Calfactant
Product type	Biological pulmonary surfactant
Source	Bovine lung extract
Route	Intratracheal
Primary indication	Neonatal respiratory distress syndrome
FDA approval	1998
BLA	BLA 103909
Primary setting	Neonatal intensive-care units
Main competitors	CUROSURF and SURVANTA
Current exclusivity profile	Mature product; original regulatory exclusivity expired
Standalone revenue disclosure	Not publicly reported

When did INFASURF lose exclusivity?

INFASURF lost its original FDA regulatory exclusivity many years ago. The product was approved in 1998, and the statutory exclusivity period associated with an older biological product has expired.[1]

The commercial issue is different from regulatory exclusivity. Pulmonary surfactants are complex biological products administered in acute hospital settings. A competitor must establish product quality, manufacturing consistency, clinical comparability and an acceptable FDA regulatory pathway. Those requirements create practical barriers even after formal exclusivity ends.

INFASURF does not have the same patent framework as a conventional small-molecule drug. A biological product is regulated through a biologics license application rather than a traditional new drug application. The Orange Book is therefore not the primary source for evaluating INFASURF exclusivity. The FDA Purple Book is the more relevant source for biological-product reference and biosimilar information.[2]

Is INFASURF listed in the Orange Book?

The Orange Book is not the central exclusivity register for INFASURF because calfactant is regulated as a biologic. Patent-based substitution analysis for INFASURF should not rely on the conventional Orange Book Paragraph IV model used for small-molecule products.

The relevant questions are:

1. Whether the product has an active FDA biologics license.
2. Whether a biosimilar or interchangeable product has been approved.
3. Whether patents cover the composition, formulation, manufacturing process or delivery method.
4. Whether state substitution rules permit automatic substitution.
5. Whether the sponsor has enforceable contractual or manufacturing rights.

What patents protect INFASURF?

Publicly available FDA materials identify INFASURF as a mature biological product but do not provide a current, consolidated patent estate comparable to the patent listings commonly associated with branded small-molecule drugs.[1]

The most commercially relevant potential patent categories are:

Patent category	Relevance to INFASURF	Commercial status
Calfactant composition	Could cover surfactant composition or protein/lipid ratios	Core product patents would be expected to be old or expired
Extraction and purification	Could cover isolation of bovine surfactant components	May remain relevant as manufacturing know-how even if patents have expired
Formulation	Could cover concentration, stability or suspension characteristics	No widely recognized current blocking formulation estate is publicly identified
Administration method	Could cover dosing or delivery procedures	Method protection is difficult to enforce against routine hospital use
Manufacturing process	Could cover sourcing, extraction, sterilization or filling	Trade secrets and supplier controls may be more important than patents

A precise patent-expiration analysis cannot be derived from the FDA label alone. For a transaction or litigation review, the relevant patent families would include U.S. patents assigned to the product owner, manufacturing affiliates and predecessor companies, together with terminal disclaimers, maintenance-fee records and foreign counterparts.

How strong is the INFASURF patent estate?

The patent estate appears commercially weak relative to the product’s remaining market position. INFASURF’s defensibility is more likely to come from operational barriers than from a broad, unexpired composition-of-matter patent.

The strongest protection is likely to be:

• Manufacturing know-how for bovine-lung extraction and purification.
• Qualified animal-tissue supply.
• Sterility and viral-safety controls.
• Batch consistency and release testing.
• Hospital familiarity with dosing and administration.
• Inclusion in neonatal protocols and purchasing contracts.

Those factors can slow competition but do not create statutory market exclusivity. They also expose the product to price competition if another supplier demonstrates comparable quality and obtains regulatory approval.

How does INFASURF compare with CUROSURF and SURVANTA?

INFASURF competes in a concentrated market dominated by three established animal-derived surfactants. The products differ in source material, phospholipid composition, protein content, dosing volume and clinical development history.

Product	Active substance	Biological source	Sponsor or commercial owner	Market position
INFASURF	Calfactant	Bovine lung extract	Commercial ownership has changed over time; current product materials identify the licensed manufacturer or sponsor	Established U.S. neonatal product
CUROSURF	Poractant alfa	Porcine lung extract	Chiesi Farmaceutici	Major U.S. and international competitor
SURVANTA	Beractant	Bovine lung extract	AbbVie	Established legacy competitor

CUROSURF has a strong commercial position because of broad international availability, extensive neonatal use and the Chiesi hospital portfolio. SURVANTA remains a recognized comparator but faces the same maturity and pricing pressures affecting INFASURF.

Clinical selection can depend on:

• Gestational age and birth weight.
• Whether the product is used prophylactically or as rescue therapy.
• Dose volume and redosing requirements.
• Institutional protocol.
• Neonatologist preference.
• Product availability during emergency delivery.
• Contracted hospital pricing.

Product switching is possible, but neonatal intensive-care units tend to value supply continuity and established administration protocols. That creates customer retention even when products are clinically substitutable.

What is the FDA regulatory status of INFASURF?

INFASURF remains an FDA-approved biological product for intratracheal use in premature infants with respiratory distress syndrome.[1]

The product does not have the profile of a recently approved biologic with active statutory exclusivity. The commercial regulatory risks are instead operational:

• Maintaining the BLA and manufacturing compliance.
• Demonstrating consistent potency and purity.
• Managing animal-derived raw materials.
• Meeting sterility and viral-safety requirements.
• Maintaining supply during neonatal demand spikes.
• Addressing FDA inspection findings or manufacturing changes.

Because INFASURF is derived from animal tissue, raw-material controls are material. A supply disruption affecting bovine lung procurement, extraction capacity or release testing could affect sales more rapidly than ordinary hospital formulary competition.

Are biosimilar or generic challenges likely for INFASURF?

No widely established FDA-approved biosimilar or interchangeable product for INFASURF is identified in the public Purple Book materials reviewed for this analysis.[2]

A conventional generic substitution pathway is not available in the same manner as it is for a small-molecule tablet. A competing surfactant would need to pursue an appropriate biologics pathway or obtain its own approval through a route accepted by the FDA.

The principal barriers include:

1. Complex biological composition.
2. Difficulty reproducing source material and protein-lipid characteristics.
3. Need for validated manufacturing controls.
4. Clinical and analytical comparability requirements.
5. Limited commercial scale relative to large pharmaceutical markets.
6. Hospital conservatism in neonatal critical care.

The absence of an approved biosimilar does not mean the product has durable monopoly protection. Competitors can challenge the market through a distinct reference product, differentiated dosing, contract pricing or international supply.

What generic entry risks exist for INFASURF?

The most plausible entry scenario is not immediate automatic substitution. It is a hospital-level share shift caused by a competing surfactant or a lower-cost biologic product.

Entry scenario	Probability profile	Impact on INFASURF
Traditional ANDA generic	Low relevance because INFASURF is a biologic	Limited direct risk
Biosimilar or follow-on surfactant	Technically possible but demanding	High if approved with competitive pricing
Existing-product price competition	Ongoing	Moderate margin pressure
Hospital contract displacement	Realistic	High account-level impact
Manufacturing disruption	Periodic operational risk	Potentially severe but episodic
New synthetic surfactant	Technically differentiated	Could alter long-term market structure

A competing product would not need to replace INFASURF across the entire market. Winning a limited number of high-volume neonatal centers could reduce utilization and weaken purchasing leverage.

What is the financial trajectory of INFASURF?

INFASURF is a mature, specialized hospital product rather than a high-growth biologic franchise. Public companies associated with the product have generally not reported INFASURF revenue as a separate line item in recent financial filings. The absence of standalone revenue prevents a reliable calculation of current annual sales, gross margin or contribution profit.

The financial trajectory can be described in four stages.

Launch and adoption

Following FDA approval in 1998, INFASURF entered a market in which surfactant replacement was an established standard of neonatal care. Initial growth depended on adoption by neonatal intensive-care units and differentiation from other animal-derived products.

Maturity

The product later entered a stable commercial phase. Demand became linked to:

• Number of very preterm births.
• Neonatal intensive-care admissions.
• Product availability.
• Hospital formulary decisions.
• Average number of doses per treated infant.

Portfolio ownership and commercialization

The product has been commercialized through corporate ownership and licensing arrangements over time. Those transitions can change reported revenue visibility, sales-force allocation and manufacturing economics without changing clinical demand.

Current financial profile

The likely current profile is:

• Low to moderate unit growth.
• Stable but contracting pricing in institutional accounts.
• Limited promotional upside.
• High manufacturing and quality-control requirements.
• Potentially attractive cash generation if production is efficient.
• Meaningful downside from a single major hospital contract loss or supply interruption.

INFASURF revenue exposure is therefore more sensitive to market share and net price than to new indication expansion.

What factors drive INFASURF demand?

Demand is primarily clinical and demographic. The main drivers are:

• Incidence of very preterm birth.
• Use of antenatal corticosteroids.
• Neonatal respiratory support practices.
• Number of infants requiring surfactant therapy.
• Prophylactic versus rescue-treatment protocols.
• Redosing frequency.
• Hospital births at centers with neonatal intensive-care units.
• Relative product pricing and availability.

The market does not have the volume profile of adult chronic-care medicines. Each patient may require one or more doses, but the treated population is limited. Revenue can vary by quarter because premature deliveries and hospital purchasing patterns are uneven.

What manufacturing and intellectual-property barriers protect INFASURF?

Manufacturing is a more important barrier than patent exclusivity. INFASURF requires a controlled biological supply chain from animal tissue procurement through extraction, purification, sterilization, filling and release.

Key barriers include:

• Consistent bovine lung sourcing.
• Control of animal-origin contaminants.
• Viral and microbial safety.
• Reproducible phospholipid and protein composition.
• Batch-release testing.
• Cold-chain or controlled storage requirements.
• FDA oversight of manufacturing changes.
• Limited availability of qualified manufacturing sites.

These barriers can support pricing and reduce short-term entry risk. They also create fixed-cost exposure. A small market with high compliance costs can be unattractive to new entrants unless the entrant already has a biological manufacturing platform.

What litigation and Paragraph IV challenges affect INFASURF?

No major current Paragraph IV litigation involving INFASURF is identified in the standard small-molecule framework. Paragraph IV litigation is tied to an ANDA applicant challenging Orange Book-listed patents. That mechanism does not map directly onto a mature biologic marketed under a BLA.

Potential legal disputes would more likely involve:

• BLA ownership or licensing rights.
• Manufacturing and supply agreements.
• Patent claims covering extraction or formulation.
• Trade-secret misappropriation.
• Product liability.
• FDA manufacturing enforcement.
• Hospital contracting or distribution arrangements.

No active, high-profile patent litigation materially affecting INFASURF’s U.S. market position is identified in the public record reviewed for this analysis.

What licensing deals affect INFASURF?

INFASURF has been associated with changing corporate and commercialization arrangements. Those arrangements matter because a mature hospital product can generate value through licensing, distribution and manufacturing rights even when it has limited patent life.

The economically relevant contract terms would include:

• Geographic exclusivity.
• Minimum purchase commitments.
• Transfer pricing.
• Manufacturing responsibilities.
• Regulatory ownership.
• Supply continuity obligations.
• Rights to improvements or new formulations.
• Termination rights.

Public disclosures do not provide a current, complete standalone schedule of all INFASURF licensing economics. The product should therefore be valued as a mature commercial asset only after confirming the active BLA holder, U.S. commercial rights, manufacturing entity and royalty obligations.

What are the likely generic launch scenarios?

The most likely scenarios are gradual share erosion rather than an abrupt generic cliff.

Scenario	Market effect	Financial implication
No approved follow-on product	INFASURF retains a defensible niche	Stable revenue with pricing pressure
Hospital price competition intensifies	Share shifts by account	Lower net price and margin
Biosimilar receives FDA approval	Rapid tender and formulary pressure	Potential material revenue decline
Supply interruption at a competitor	Temporary share gain	Short-term volume increase
Manufacturing failure at INFASURF	Product shortages and customer loss	Severe downside
New synthetic surfactant succeeds clinically	Long-term category disruption	Structural erosion

The base case is a mature product with stable but limited growth, subject to contracting pressure. The downside case is an approved follow-on product combined with aggressive hospital contracting. The upside case depends mainly on competitor supply disruption or improved commercial execution, not on market expansion.

How does INFASURF compare with competing neonatal drugs?

INFASURF differs from most neonatal medicines because it is administered during an acute hospital episode and competes primarily on clinical familiarity, supply and institutional economics.

Compared with CUROSURF, INFASURF may face a disadvantage in global commercial scale and portfolio support. Compared with SURVANTA, it competes with another established bovine-derived product serving a similar clinical setting. Neither comparison creates a clear patent-based advantage for INFASURF.

The product’s strongest commercial asset is embedded use in neonatal care protocols. Its weakest asset is the lack of visible remaining exclusivity and limited public financial transparency.

Key Takeaways

• INFASURF is a mature calfactant biological product approved by the FDA in 1998.
• Original regulatory exclusivity has expired.
• Orange Book and Paragraph IV analysis are not the primary frameworks for this BLA product.
• No widely recognized active patent estate is publicly visible as the principal barrier to entry.
• Manufacturing know-how, animal-tissue sourcing, quality systems and hospital familiarity are the main practical defenses.
• CUROSURF and SURVANTA are the principal commercial comparators.
• No established FDA-approved biosimilar or interchangeable INFASURF competitor is identified.
• Standalone INFASURF revenue is not publicly disclosed.
• The likely financial profile is stable-to-declining revenue, with margin pressure from hospital contracting.
• The main risks are hospital formulary displacement, supply interruptions and future follow-on biological competition.

FAQs

Is INFASURF still commercially available?

INFASURF remains an FDA-approved neonatal pulmonary surfactant, subject to ongoing commercial supply and manufacturing compliance.

Is calfactant the same as poractant alfa?

No. Calfactant is the active substance in INFASURF, while poractant alfa is the active substance in CUROSURF. Both are animal-derived pulmonary surfactants but are not the same product.

Can hospitals automatically substitute a biosimilar for INFASURF?

Automatic substitution would depend on FDA interchangeability status and applicable state law. A competing pulmonary surfactant would not automatically become substitutable merely because it received FDA approval.

Does INFASURF have orphan-drug protection?

INFASURF’s current commercial position does not depend on active orphan-drug exclusivity. Its FDA approval dates to 1998, and the relevant original exclusivity periods have expired.

What is the largest financial risk to INFASURF?

The largest risk is likely loss of hospital contracts to competing surfactants, especially if a competitor combines lower net pricing with reliable supply and equivalent neonatal-care acceptance.

References

1. U.S. Food and Drug Administration. (2017). INFASURF (calfactant) intratracheal suspension prescribing information. FDA.
2. U.S. Food and Drug Administration. (n.d.). Purple Book: Database of licensed biological products. FDA.
3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. FDA.
4. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.