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SURFAXIN

NDA

LUCINACTANT | N021746 | LEES PHARMACEUTICAL HK LTD

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Primus Pharmaceuticals, Inc. FDA-2026-P-8647 Primus Pharmaceuticals, Inc. filed a citizen petition requesting that the FDA take regulatory action regarding certain aspects of drug product applications and related procedures. The petition sought clarification or modification of FDA's policies concerning abbreviated new drug application (ANDA) p	Other	2026-08-06	Open	Primus Pharmaceuticals, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

10 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old NCT00578734	Phase 2	Completed	Windtree Therapeutics	165	2007-06 → 2010-04
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age NCT02636868	Phase 2	Completed	Windtree Therapeutics	221	2015-12 → 2019-08-06
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates NCT02074059	Phase 2	Completed	Windtree Therapeutics	80	2014-02 → 2015-11
Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease NCT00934362	Phase 2	Completed	University of North Carolina, Chapel Hill	16	2008-10 → 2010-08
KL₄Surfactant Treatment in Patients With ARDS NCT00215553	Phase 2	Terminated	Windtree Therapeutics	124	2001-05 → 2006-02
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age NCT04264156	Phase 2	Terminated	Windtree Therapeutics	12	2020-04-18 → 2021-03-28
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants NCT00807235	Phase 2	Terminated	Windtree Therapeutics	17	2005-01 → 2005-09
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.NCT00215540	Phase 2	Terminated	Windtree Therapeutics	136	2005-02 → 2006-07
Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA NCT02528318	Phase 2	Terminated	Windtree Therapeutics	48	2015-08 → 2017-08-11
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome NCT00004500	Phase 3	Terminated	Windtree Therapeutics	69	2000-03 → 2004-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 13, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 8.5ML

0 patents0 exclusivities▴

SUSPENSION;INTRATRACHEAL | Approved: Mar 6, 2012

No patent or exclusivity listings for this strength.