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
Formulation / Manufacturing:	see details
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

Anatomical Therapeutic Chemical (ATC) Classes for EXOSURF NEONATAL

R05CA	Expectorants
R05C	EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

R07AA	Lung surfactants
R07A	OTHER RESPIRATORY SYSTEM PRODUCTS
R07	OTHER RESPIRATORY SYSTEM PRODUCTS
R	Respiratory system

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
Canada	1184503	SURFACTANT SYNTHETIQUE (LUNG SURFACTANT COMPOSITIONS)
Mexico	9203533	COMPOSICIONES AGENTES TENSIOACTIVOS PULMONARES.
Bulgaria	60737
Netherlands	930059
European Patent Office	0050793	LUNG SURFACTANT COMPOSITIONS
Japan	S5799524	MAMMAL LUNG SURFACE ACTIVE DRUG COMPOSITION

Supplementary Protection Certificates for EXOSURF NEONATAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
0984957	1290006-4	Sweden		PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
0984957	C00984957/02	Switzerland		PRODUCT NAME: ESOMEPRAZOL + ACETYLSALICYLSAEURE ; REGISTRATION NO/DATE: SWISSMEDIC 62119 26.06.2012
0050793	94C0009	Belgium		PRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
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