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Details for Generic Name: lucinactant

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Lucinactant is the generic ingredient in one branded drug marketed by Discovery Labs and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for Generic Name: lucinactant

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers: see list1

Clinical Trials for: lucinactant

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

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

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

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

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

Courtesy of ClinicalTrials.org
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
SURFAXIN
lucinactant
SUSPENSION;INTRATRACHEAL021746-001Mar 6, 2012RXYes5,407,914<disabled>YY<disabled>
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Non-Orange Book Patents for Generic Ingredient: lucinactant

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
5,789,381 Pulmonary surfactant proteins and related polypeptides<disabled in preview>
5,164,369 Pulmonary surfactant protein and related polypeptide<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>
6,613,734 Peptides-containing liposomal surfactants<disabled in preview>
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International Patent Family for Ingredient: lucinactant

Country Document Number Publication Date
Spain2182821Mar 16, 2003
JapanH11262389Sep 28, 1999
European Patent Office1005485Jun 07, 2000
Norway177309May 15, 1995
Ireland921897Dec 16, 1992
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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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