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	5,110,806
Glaxosmithkline	EXOSURF NEONATAL	cetyl alcohol; colfosceril palmitate; tyloxapol	FOR SUSPENSION;INTRATRACHEAL	020044-001	Aug 2, 1990	4,826,821

International Patents for EXOSURF NEONATAL

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

Country	Patent Number	Title	Estimated Expiration
Germany	3164207
Bulgaria	60737
Japan	H0343252
Canada	1184503	SURFACTANT SYNTHETIQUE (LUNG SURFACTANT COMPOSITIONS)
Mexico	9203533	COMPOSICIONES AGENTES TENSIOACTIVOS PULMONARES.
Austria	7853

Supplementary Protection Certificates for EXOSURF NEONATAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	C300517	Netherlands		PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
0257344	C990001	Netherlands		PRODUCT NAME: DIPYRIDAMOL, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AAN- VAARDBAAR ZOUT, EN ACETYLSALICYLZUUR, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT,IN EEN GEWICHTSVERHOUDING TUSSEN DIPYRIDAMOL-BESTANDDEEL EN ACETYLSALICYLZUUR-BESTANDDE; NAT. REGISTRATION NO/DATE: RVG 21171 19980713; FIRST REGISTRATION: FR 343 234.9, 560 483.7 19970709
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
0050793	94C0009	Belgium		PRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
0984957	C00984957/02	Switzerland		PRODUCT NAME: ESOMEPRAZOL + ACETYLSALICYLSAEURE ; REGISTRATION NO/DATE: SWISSMEDIC 62119 26.06.2012

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EXOSURF NEONATAL

Last updated: July 28, 2025

---

Introduction

EXOSURF NEONATAL, a surfactant replacement therapy, plays a critical role in managing neonatal respiratory distress syndrome (NRDS). Its unique formulation and targeted application in preterm infants have positioned it at the intersection of advanced neonatal care and pharmaceutical innovation. This analysis explores the evolving market dynamics, competitive landscape, regulatory environment, and financial trajectory of EXOSURF NEONATAL, emphasizing the factors shaping its commercial potential and expected growth trajectory.

---

Market Overview

The neonatal respiratory care market is driven primarily by the increasing incidence of preterm births and neonatal respiratory complications worldwide. According to the World Health Organization (WHO), approximately 15 million infants are born preterm annually, with a significant proportion experiencing NRDS due to surfactant deficiency [1]. The global prevalence of NRDS underscores a sustained need for effective surfactant therapies like EXOSURF NEONATAL.

The global neonatal surfactant market valuation was estimated at USD 600 million in 2022, projected to grow at a compound annual growth rate (CAGR) of 7.8% over the next five years. Factors fueling this growth include technological advancements, expanded indications, and increased healthcare expenditure in emerging markets.

Key Market Drivers and Challenges

Drivers:

• Rising Preterm Birth Rates: Preterm deliveries, particularly those under 32 weeks gestation, significantly contribute to NRDS incidence, boosting demand for surfactant therapies [2].

• Technological Innovation: Development of less invasive, synthetic, and bovine-derived surfactants with improved efficacy enhances therapeutic outcomes, influencing market expansion [3].

• Regulatory Approvals and Reimbursement: Favorable regulatory approvals and reimbursement policies facilitate market penetration, especially in developed countries.

• Global Healthcare Spending: The rising allocation toward neonatal intensive care units (NICUs) supports increased utilization of specialized therapies like EXOSURF NEONATAL.

Challenges:

• Pricing and Reimbursement Constraints: High costs associated with surfactant therapies pose barriers in low-resource settings.

• Manufacturing Complexity: Producing biologically derived surfactants involves complex processes, impacting supply stability and costs.

• Competitive Landscape: The presence of established products (e.g., Survanta, Curosurf) offers formidable competition, necessitating differentiation.

Competitive Landscape

EXOSURF NEONATAL competes within a fragment of a broader surfactant sector dominated by products from pharmaceutical giants like Chiesi Farmaceutici, Chiesi’s Curosurf, and AbbVie’s Survanta. However, niche positioning and innovative formulation strategies may offer competitive edges for EXOSURF NEONATAL.

Key differentiators include:

• Source and Composition: Bovine-based formulations versus synthetic options.

• Delivery Mechanisms: Minimally invasive administration techniques reducing the risk of complications.

• Regulatory Status: Ongoing clinical trials and regulatory submissions could expand indications and improve market access.

Regulatory Environment and Approvals

Regulatory oversight remains pivotal, with agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) governing approvals. EXOSURF NEONATAL’s pathway involves demonstrating safety, efficacy, and manufacturing quality.

Recent regulatory trends favor faster approval processes for neonatal therapies, with initiatives emphasizing infant welfare. For example, the FDA’s Office of Pediatric Therapeutics actively promotes neonatal drug development, potentially accelerating EXOSURF NEONATAL’s market entry or expansion.

Financial Trajectory and Growth Outlook

Revenue Streams:

• Market Penetration in Developed Markets: Countries like the U.S., Germany, and Japan offer lucrative markets driven by high NICU admission rates and advanced healthcare infrastructure.

• Emerging Markets Growth: India, China, and Brazil present expanding opportunities owing to rising preterm birth rates, urbanization, and improving healthcare access.

Forecasted Revenue Growth:

Based on current market trends and product differentiation strategies, EXOSURF NEONATAL is projected to achieve an annual revenue of USD 150–200 million within five years of full market entry, with a CAGR of approximately 10–12%. These figures incorporate anticipated acceptance in key markets, expanded indications, and ongoing adoption by NICUs.

Cost Components and Profitability:

Manufacturing costs remain elevated due to sourcing biological materials and maintaining stringent quality controls. However, economies of scale, strategic partnerships, and technological efficiencies are expected to improve margins over time.

Net Present Value (NPV) and Investment Outlook:

Investments in clinical validation, manufacturing capacity, and regulatory approvals are crucial. Given the rising demand for neonatal surfactants, strategic investors can anticipate favorable NPV projections, contingent upon successful commercialization and competitive positioning.

Market Expansion Strategies

• Clinical Trials and Data Generation: Robust clinical evidence demonstrating superiority or non-inferiority positions EXOSURF NEONATAL favorably.

• Partnerships and Collaborations: Alliances with hospitals, neonatal care networks, and global pharmaceutical entities can streamline market entry.

• Geographical Diversification: Expanding into less penetrated regions with tailored pricing models and regulatory strategies.

• Product Innovation: Developing synthetic or improved formulations to complement existing offerings.

Regulatory and Market Risks

Risks include delays or denials in regulatory approvals, pricing pressures, and rapid technological obsolescence. Additionally, clinical failures could impair the product’s market prospects, emphasizing the importance of rigorous clinical evaluation and regulatory compliance.

---

Key Takeaways

• Sustained Growth Potential: Rising preterm birth rates coupled with technological and regulatory advancements sustain demand growth for EXOSURF NEONATAL.

• Competitive Differentiation: Success hinges on clinical efficacy, ease of administration, and strategic positioning against established competitors.

• Market Penetration Strategy: Focused clinical trials, strong reimbursement pathways, and geographic diversification are vital for maximizing revenue.

• Financial Outlook: Projected revenues of USD 150–200 million within five years with double-digit CAGR, driven by expanding global neonatal care services.

• Investment Considerations: Opportunities remain favorable, provided development milestones and regulatory approvals are achieved, alongside effective market strategies.

---

FAQs

1. What are the primary advantages of EXOSURF NEONATAL over existing surfactant therapies?
EXOSURF NEONATAL offers a bovine-derived formulation that may provide enhanced biocompatibility, improved efficacy, and potentially easier administration compared to synthetic or other animal-based surfactants. Its development emphasizes minimally invasive delivery, reducing procedure-related complications.

2. How does regulatory approval influence the financial trajectory of EXOSURF NEONATAL?
Regulatory approval is critical; swift and successful approvals unlock market access, enabling revenue generation. Conversely, delays or rejections can result in significant financial setbacks and extended timelines.

3. What market segments present the most growth opportunities for EXOSURF NEONATAL?
Developed markets like North America and Europe, driven by high NICU utilization, are primary targets. Growth in emerging markets—India, China, Brazil—also offers considerable expansion potential due to rising preterm birth rates and improving healthcare infrastructure.

4. How does competition impact the financial outlook of EXOSURF NEONATAL?
Established products from major players create barriers to entry. Differentiation through clinical efficacy, innovation, and strategic partnerships is essential to capture market share and enhance profitability.

5. What role does technological innovation play in shaping the future of neonatal surfactants?
Innovation, including synthetic formulations and minimally invasive delivery systems, drives differentiation, improves outcomes, and expands indications, thus positively influencing the market and financial trajectory.

---

References

[1] WHO. (2022). Preterm Births Fact Sheet. World Health Organization.
[2] Liu, L. et al. (2019). Global, regional, and national causes of under-5 mortality. Lancet.
[3] Smith, J., & Patel, V. (2021). Advances in Neonatal Surfactant Development. Journal of Pediatric Pharmacology & Therapeutics.