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
Glaxosmithkline	EXOSURF NEONATAL	cetyl alcohol; colfosceril palmitate; tyloxapol	FOR SUSPENSION;INTRATRACHEAL	020044-001	Aug 2, 1990
Glaxosmithkline	EXOSURF NEONATAL	cetyl alcohol; colfosceril palmitate; tyloxapol	FOR SUSPENSION;INTRATRACHEAL	020044-001	Aug 2, 1990

International Patents for EXOSURF NEONATAL

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

Country	Patent Number	Title	Estimated Expiration
Czechoslovakia	9103849
Mexico	9203533	COMPOSICIONES AGENTES TENSIOACTIVOS PULMONARES.
Germany	19375071
Austria	7853
European Patent Office	0050793	LUNG SURFACTANT COMPOSITIONS
Japan	H0343252

Supplementary Protection Certificates for EXOSURF NEONATAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0050793	94C0009	Belgium		PRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
0050793	SPC/GB93/042	United Kingdom		SPC/GB93/042, EXPIRES: 20051213
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
0257344	20/1999	Austria		PRODUCT NAME: DIPYRIDAMOL IN KOMBINATION MIT ACETYLSALICYLSAEURE; NAT. REGISTRATION NO/DATE: 1-22779 19981112; FIRST REGISTRATION: FR NL 22160 19970709
0984957	C300517	Netherlands		PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812

EXOSURF NEONATAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Exosurf Neonatal

Introduction to Exosurf Neonatal

Exosurf Neonatal, a synthetic lung surfactant known as colfosceril palmitate, is a critical treatment for neonatal respiratory distress syndrome (RDS), particularly in preterm infants. This article delves into the market dynamics and financial trajectory of Exosurf Neonatal, highlighting its impact, cost-effectiveness, and future prospects.

Market Growth Drivers

The market for Exosurf Neonatal is driven by several key factors:

• Rise in Preterm Births: The increasing number of preterm births globally has led to a higher prevalence of RDS, creating a significant demand for effective treatments like Exosurf Neonatal[1].
• Advancements in Neonatal Care: Continuous improvements in neonatal intensive care and the adoption of advanced therapies such as surfactant replacement and oxygen therapy are driving market growth[1].
• Technological Advancements: Innovations in synthetic and natural surfactants, including non-invasive ventilation techniques and precision medicine, are enhancing the efficacy of treatments like Exosurf Neonatal[4].

Cost-Effectiveness of Exosurf Neonatal

The cost-effectiveness of Exosurf Neonatal has been a focal point of several studies:

• Reduction in Hospital Costs: Studies have shown that rescue therapy with Exosurf Neonatal can reduce average hospital costs significantly. For instance, a study revealed a $16,600 reduction in hospital costs, which is more than the cost of the surfactant itself ($450 to $900)[5].
• Pharmacoeconomic Evaluation: Pharmacoeconomic analyses indicate that Exosurf Neonatal can reduce costs per survivor by 9 to 48% compared to placebo or historical controls. This is evident in both larger and smaller infants[3].
• Combined Therapies: The use of Exosurf Neonatal in combination with antenatal corticosteroids has been shown to be highly cost-effective, producing the most survivors and the lowest number of intensive and high dependency care days in hospital[2].

Market Size and Forecast

The global neonatal respiratory distress syndrome treatment market, which includes Exosurf Neonatal, is expected to experience significant growth:

• Current Market Size: The market was valued at US$ 780.1 million in 2022[1].
• Projected Growth: It is expected to reach over US$ 1.6 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 7.9%[1].

Regional Dynamics

The market for Exosurf Neonatal varies by region:

• North America: This region is projected to account for a leading share in the global market due to the rise in preterm births and the adoption of advanced neonatal care[1].
• Asia Pacific: This region is also lucrative, driven by increasing awareness about RDS and advancements in healthcare infrastructure, although challenges such as low access to medical treatment in some developing countries exist[1].

Competitive Landscape

The market for Exosurf Neonatal is competitive, with several key players:

• Chiesi Farmaceutici: Known for its innovative respiratory therapies, including natural surfactants like Curosurf®, which is a competitor to Exosurf Neonatal[4].
• Windtree Therapeutics, Inc.: This company is developing synthetic surfactant formulations, such as Aerosurf®, which aims to deliver aerosolized surfactant non-invasively[4].

Clinical Outcomes and Benefits

Exosurf Neonatal has demonstrated significant clinical benefits:

• Reduction in Mortality: Studies have shown that Exosurf Neonatal reduces mortality rates in preterm infants. For instance, infants given Exosurf had a significant reduction in the incidence of pulmonary interstitial emphysema (PIE) and a marginal decrease in the incidence of pneumothorax[2].
• Reduced Ventilation Days: The use of Exosurf Neonatal has been associated with fewer days on mechanical ventilation, which reduces the overall cost of care and improves patient outcomes[2].

Future Prospects

The future of Exosurf Neonatal looks promising due to several factors:

• Ongoing Research and Development: Continuous clinical trials and research are aimed at improving the efficacy and cost-effectiveness of surfactant therapies. The optimal timing of surfactant administration and its combination with other therapies are areas of ongoing investigation[3].
• Technological Innovations: Advances in non-invasive ventilation and precision medicine are expected to further enhance the market for Exosurf Neonatal and similar treatments[4].

Key Takeaways

• Exosurf Neonatal is a cost-effective treatment for neonatal RDS, reducing hospital costs and improving patient outcomes.
• The market is driven by the rise in preterm births and advancements in neonatal care.
• Regional growth is significant in North America and Asia Pacific.
• The competitive landscape includes other surfactant therapies, but Exosurf Neonatal remains a key player.
• Ongoing research and technological innovations are expected to further boost the market.

Frequently Asked Questions (FAQs)

1. What is Exosurf Neonatal used for? Exosurf Neonatal is used to treat neonatal respiratory distress syndrome (RDS) in preterm infants.

2. How cost-effective is Exosurf Neonatal? Exosurf Neonatal has been shown to reduce hospital costs and improve patient outcomes, making it a cost-effective treatment for RDS.

3. What are the key drivers of the Exosurf Neonatal market? The key drivers include the rise in preterm births, advancements in neonatal care, and technological innovations in surfactant therapies.

4. Which regions are expected to lead the market growth for Exosurf Neonatal? North America and Asia Pacific are projected to lead the market growth due to the rise in preterm births and advancements in healthcare infrastructure.

5. What are the future prospects for Exosurf Neonatal? The future prospects are promising, with ongoing research and development aimed at improving efficacy and cost-effectiveness, and technological innovations in non-invasive ventilation and precision medicine.

Cited Sources

1. GlobeNewswire: "Neonatal Respiratory Distress Syndrome Treatment Market to Surpass USD 1.6 Bn by 2031: Latest Study by TMR"[1]
2. CDC Stacks: "Economics of Reproductive and Infant Health: An Assessment of Neonatal Intensive Care"[2]
3. PubMed: "Colfosceril palmitate. A pharmacoeconomic evaluation of a synthetic surfactant preparation (Exosurf Neonatal) in infants with respiratory distress syndrome"[3]
4. BioSpace: "Respiratory Distress Syndrome Market to Reach a CAGR of 4.56 During 2024-2034: Impelled by Extensive R&D Activities"[4]
5. PubMed: "Cost effects of surfactant therapy for neonatal respiratory distress syndrome"[5]