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Profile for Tradename: SURFAXIN

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Surfaxin is a drug marketed by Discovery Labs and is included in one NDA. It is available from one supplier. There is one patent protecting this drug.

This drug has forty-two patent family members in fourteen countries.

The generic ingredient in SURFAXIN is lucinactant. One supplier is listed for this compound. Additional details are available on the lucinactant profile page.

Summary for Tradename: SURFAXIN

Suppliers / Packagers: see list1

Clinical Trials for: SURFAXIN

SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
Status: Terminated Condition: Respiratory Distress Syndrome, Newborn; Premature Birth; Bronchopulmonary Dysplasia

Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
Status: Terminated Condition: Respiratory Distress Syndrome

Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
Status: Completed Condition: Acute Hypoxemic Respiratory Failure

Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease
Status: Completed Condition: Cystic Fibrosis

Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
Status: Recruiting Condition: Respiratory Distress Syndrome

Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA
Status: Not yet recruiting Condition: Respiratory Distress Syndrome

Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
Status: Terminated Condition: Meconium Aspiration

KL₄Surfactant Treatment in Patients With ARDS
Status: Terminated Condition: Acute Respiratory Distress Syndrome

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Discovery Labs
SUSPENSION;INTRATRACHEAL021746-001Mar 6, 2012DISCNNo5,407,914<disabled>YY <disabled>
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Non-Orange Book Patents for Tradename: SURFAXIN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,164,369 Pulmonary surfactant protein and related polypeptide<disabled in preview>
6,613,734 Peptides-containing liposomal surfactants<disabled in preview>
5,789,381 Pulmonary surfactant proteins and related polypeptides<disabled in preview>
6,013,619 Pulmonary surfactants and therapeutic uses, including pulmonary lavage<disabled in preview>
5,260,273 Pulmonary surfactant protein and related polypeptide<disabled in preview>
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International Patent Family for Tradename: SURFAXIN

Country Document Number Publication Date
European Patent Office0593094Apr 20, 1994
World Intellectual Property Organization (WIPO)8906657Jul 27, 1989
Canada2111342Dec 23, 1992
Denmark0590006Jan 06, 2003
Finland102180Oct 30, 1998
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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