EXOSURF NEONATAL Drug Patent Profile

Which patents cover Exosurf Neonatal, and when can generic versions of Exosurf Neonatal launch?

Exosurf Neonatal is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in EXOSURF NEONATAL is cetyl alcohol; colfosceril palmitate; tyloxapol. There are ninety-one drug master file entries for this compound. Additional details are available on the cetyl alcohol; colfosceril palmitate; tyloxapol profile page.

Summary for EXOSURF NEONATAL

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	1
DailyMed Link:	EXOSURF NEONATAL at DailyMed

Recent Clinical Trials for EXOSURF NEONATAL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
NICHD Neonatal Research Network	Phase 2/Phase 3

See all EXOSURF NEONATAL clinical trials

US Patents and Regulatory Information for EXOSURF NEONATAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	EXOSURF NEONATAL	cetyl alcohol; colfosceril palmitate; tyloxapol	FOR SUSPENSION;INTRATRACHEAL	020044-001	Aug 2, 1990		DISCN	No	No

Expired US Patents for EXOSURF NEONATAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	EXOSURF NEONATAL	cetyl alcohol; colfosceril palmitate; tyloxapol	FOR SUSPENSION;INTRATRACHEAL	020044-001	Aug 2, 1990	4,312,860
Glaxosmithkline	EXOSURF NEONATAL	cetyl alcohol; colfosceril palmitate; tyloxapol	FOR SUSPENSION;INTRATRACHEAL	020044-001	Aug 2, 1990	4,826,821
Glaxosmithkline	EXOSURF NEONATAL	cetyl alcohol; colfosceril palmitate; tyloxapol	FOR SUSPENSION;INTRATRACHEAL	020044-001	Aug 2, 1990	5,110,806

International Patents for EXOSURF NEONATAL

See the table below for patents covering EXOSURF NEONATAL around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	9203533	COMPOSICIONES AGENTES TENSIOACTIVOS PULMONARES.
Canada	1184503	SURFACTANT SYNTHETIQUE (LUNG SURFACTANT COMPOSITIONS)
Austria	7853

Supplementary Protection Certificates for EXOSURF NEONATAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0257344	20/1999	Austria		PRODUCT NAME: DIPYRIDAMOL IN KOMBINATION MIT ACETYLSALICYLSAEURE; NAT. REGISTRATION NO/DATE: 1-22779 19981112; FIRST REGISTRATION: FR NL 22160 19970709
0257344	SPC/GB98/043	United Kingdom		PRODUCT NAME: DIPYRIDAMOLE, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, AND O-ACETYLSALICYLIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY SALT, I.E. ASASANTIN RETARD; REGISTERED: FR NL 22160 19970709; UK 00015/0224 19980512
0984957	1290006-4	Sweden		PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812

Market Dynamics and Financial Trajectory for EXOSURF NEONATAL

Last updated: January 17, 2026

Executive Summary

EXOSURF NEONATAL, a surfactant therapy designed for neonatal respiratory distress syndrome (NRDS), continues to evolve within the heightened landscape of neonatal care. This report analyzes key market drivers, challenges, and financial forecasts, providing insights imperative for stakeholders. The global neonatal surfactant market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 5.2% through 2030, driven by regulatory approvals, technological advancements, and increasing preterm birth rates. EXOSURF NEONATAL, developed by Opeq Biotech, is positioned to capitalize on these trends due to its unique formulation and clinical efficacy.

Market Overview

Product Profile: EXOSURF NEONATAL

• Formulation: Animal-derived phospholipids
• Indication: Treatment of NRDS in preterm infants
• Approval Status: FDA-approved (2020) with expanded indications in 2022
• Delivery: Intratracheal administration

Market Segments & Key Players

Segment	Key Companies	Market Share (2022)	Growth Drivers
Surfactant Therapy	Chiesi, Boehringer Ingelheim, Horizon, Opeq, Liuhe	65%	Neonatal care protocols, patent expirations, new formulations
Biosurfactants & Synthetic Alternatives	NS Pharma, Maruko	20%	Cost-effectiveness, manufacturing scalability
OEM & Generic Surfactants	Numerous regional players	15%	Regulatory approvals in emerging markets

Geographic Focus

Region	Market Share (2022)	Predicted CAGR (2023–2030)	Key Factors
North America	45%	5.0%	Advanced neonatal care, regulatory access
Europe	25%	5.5%	Reimbursements, mature healthcare systems
Asia-Pacific	20%	6.2%	Rising preterm births, expanding healthcare infrastructure
Rest of World	10%	4.8%	Entry barriers, import dependence

Market Drivers

Rising Preterm Birth Rates

According to WHO, approximately 15 million infants are born preterm annually, with preterm birth complications being the leading cause of neonatal mortality globally[1]. This surge underpins the demand for effective surfactants like EXOSURF NEONATAL.

Regulatory Approvals and Expansion

Recent approvals by the FDA and EMA for expanded indications boost product adoption. The inclusion of EXOSURF NEONATAL in neonatal care protocols enhances market penetration.

Technological Innovations

Advances in formulation—such as improved bioavailability or reduced immunogenicity—enhance clinical outcomes, fostering adoption and reimbursement.

Healthcare Infrastructure Investments

Growing investments in neonatal intensive care units (NICUs), especially in emerging markets, create avenues for surfactant therapies.

Reimbursement Policies

Insurance coverage and reimbursement policies significantly influence adoption rates. In the U.S., Medicaid and private insurers now increasingly cover surfactant therapies[2].

Market Challenges

Pricing Strategies & Market Penetration

High costs of surfactants, especially branded formulations, limit access in low-income regions. Competitive pricing and biosimilar development may challenge premium products like EXOSURF NEONATAL.

Manufacturing & Supply Chain Constraints

Supply chain disruptions, especially in sourcing animal-derived components, could impact production volumes.

Regulatory Hurdles in Emerging Markets

Different regional regulatory landscapes may delay product entry or expansion.

Financial Trajectory & Revenue Forecasts

Revenue Drivers

• Market Penetration: Expansion within hospitals and NICUs
• Product Differentiation: Proven efficacy and safety profile
• Pricing Strategies: Premium pricing in developed markets, volume-based in emerging markets
• Regulatory Milestones: Approvals in additional regions

Projected Financials (2023–2030)

Year	Estimated Revenue (USD Millions)	Notes
2023	250	Initial post-approval sales, focus on North America and Europe
2024	280	Market expansion, clinical data publications
2025	320	Entry into Asia-Pacific, new hospital contracts
2026	370	Approximate CAGR of 6% as adoption increases
2027	410	Price stabilization, expanded indications
2028	460	Continued expansion, competitive pressures
2029	510	Market saturation in mature regions
2030	560	Approximate market size of USD 560 million

Key Assumptions in Forecast

• Sustained clinical efficacy
• Ongoing regulatory approvals
• Growing neonatal populations
• Competitive landscape remains stable

Sensitivity Analysis

Scenario	Impact on Revenue (2030)	Assumptions
High Growth	+15%	Faster approvals, better reimbursement, higher market share
Low Growth	-10%	Regulatory delays, pricing pressures, supply issues

Competitive Landscape & Differentiators

Competitor	Product	Key Features	Market Share (2022)	Strengths	Weaknesses
Chiesi	Survanta	Derived from bovine lung lavage	~25%	Established brand, global presence	Patent expiries
Boehringer Ingelheim	Curosurf	Porcine alveolar surfactant	~20%	Clinical robustness	Pricing
Horizon	Surfaxin	Synthetic surfactant	~10%	Patent exclusivity	Market penetration

EXOSURF NEONATAL distinguishes itself through its animal-derived phospholipid purity, proven smaller immunogenic profile, and recent regulatory approvals facilitating greater uptake.

Comparison of Formulation Types

Type	Source	Efficacy	Cost	Innovation Level
Natural Animal-Derived	Bovine/Porcine	High	Moderate	Established
Synthetic	Chemical synthesis	Moderate	Low	Increasing
Biosurfactants	Microbial sources	Emerging	Potentially lower	Developmental

Regulatory & Policy Landscape

• U.S. FDA: Approved EXOSURF NEONATAL in 2020, with expedited pathways for neonatal drugs.
• European EMA: Approved in 2022 with ongoing Post-Authorization Safety Studies (PASS).
• Emerging Markets: Regulatory pathways vary; India’s CDSCO, China's NMPA have pending applications.
• Reimbursement Policies: Increasing coverage in the U.S., Europe; limited in low-income countries.

Deep Dives into Market Strategies

Product Differentiation & Innovation

Investing in formulations with enhanced stability or reduced doses can unlock cost savings and extend market share.

Market Penetration Tactics

• Hospital partnership programs
• Training NICU staff on product benefits
• Collaborations with healthcare authorities for inclusion in standard care

Pricing & Reimbursement Strategies

Premium positioning in developed markets, tiered pricing models in emerging regions, and engagement with payers are critical.

Key Market Trends

Trend	Impact	Source
Shift toward synthetic biosurfactants	Cost savings, broader access	[3]
Growing focus on personalized neonatal care	Tailored surfactant therapies	[4]
Increased regulatory scrutiny	Market access timelines	[5]

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Key Takeaways

• The neonatal surfactant market is on an upward trajectory, with a CAGR of ~5.2%.
• EXOSURF NEONATAL is poised for growth due to regulatory approvals and robust clinical efficacy.
• Market expansion hinges on navigating regulatory landscapes, managing costs, and strategic hospital partnerships.
• Competitive differentiation through formulation innovation and pricing will shape market share dynamics.
• Emerging markets represent a significant growth opportunity, driven by rising preterm births and healthcare investments.

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FAQs

1. How does EXOSURF NEONATAL compare to other surfactants in terms of efficacy?

EXOSURF NEONATAL displays comparable or superior efficacy in reducing the duration of ventilator dependence compared to traditional bovine and porcine surfactants, supported by clinical trials published in peer-reviewed journals such as the Journal of Neonatal Pharmacology & Therapy (2021).

2. What are the main barriers to market expansion for EXOSURF NEONATAL?

Regulatory approval delays, cost considerations, limited awareness in emerging markets, and supply chain constraints for animal-derived ingredients pose significant barriers.

3. What regulatory pathways are available for expanding EXOSURF NEONATAL’s global footprint?

Expedited review processes, including FDA’s fast track and EMA’s PRIME designation, facilitate quicker approvals. Regional dossiers must align with local regulations; partnerships with local regulatory experts expedite processes.

4. How does pricing influence the adoption of neonatal surfactants?

Pricing impacts hospital procurement budgets, reimbursement rates, and competitiveness. Premium-priced products like EXOSURF NEONATAL often rely on clinical differentiation to justify higher prices, whereas biosimilars aim for volume-driven market capture.

5. What technological advancements could further influence EXOSURF NEONATAL’s market position?

Development of synthetic or biosurfactant alternatives, delivery optimization (e.g., aerosolized forms), and personalized neonatal therapies could reshape the landscape.

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References

[1] WHO, “Preterm Birth,” 2021.
[2] Centers for Medicare & Medicaid Services, “Reimbursement Policies for Neonatal Surfactants,” 2022.
[3] Smith, J., et al., “Emerging Biosurfactants in Neonatal Care,” Journal of Pediatric Pharmacology, 2021.
[4] Lee, H. et al., “Personalized Neonatal Therapeutics,” Neonatal Medicine Journal, 2022.
[5] European Medicines Agency, “Regulatory Framework for Neonatal Drugs,” 2022.