EXOSURF NEONATAL Drug Patent Profile
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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.
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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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | EXOSURF NEONATAL | cetyl alcohol; colfosceril palmitate; tyloxapol | FOR SUSPENSION;INTRATRACHEAL | 020044-001 | Aug 2, 1990 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | EXOSURF NEONATAL | cetyl alcohol; colfosceril palmitate; tyloxapol | FOR SUSPENSION;INTRATRACHEAL | 020044-001 | Aug 2, 1990 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EXOSURF NEONATAL
See the table below for patents covering EXOSURF NEONATAL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 19375071 | ⤷ Sign Up | |
| Bulgaria | 60737 | ⤷ Sign Up | |
| Japan | S5799524 | MAMMAL LUNG SURFACE ACTIVE DRUG COMPOSITION | ⤷ Sign Up |
| Canada | 1184503 | SURFACTANT SYNTHETIQUE (LUNG SURFACTANT COMPOSITIONS) | ⤷ Sign Up |
| European Patent Office | 0050793 | LUNG SURFACTANT COMPOSITIONS | ⤷ Sign Up |
| Mexico | 9203533 | COMPOSICIONES AGENTES TENSIOACTIVOS PULMONARES. | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EXOSURF NEONATAL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0050793 | SPC/GB93/042 | United Kingdom | ⤷ Sign Up | SPC/GB93/042, EXPIRES: 20051213 |
| 0257344 | C990001 | Netherlands | ⤷ Sign Up | 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 |
| 0257344 | 20/1999 | Austria | ⤷ Sign Up | PRODUCT NAME: DIPYRIDAMOL IN KOMBINATION MIT ACETYLSALICYLSAEURE; NAT. REGISTRATION NO/DATE: 1-22779 19981112; FIRST REGISTRATION: FR NL 22160 19970709 |
| 0984957 | 1290006-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812 |
| 0984957 | C300517 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812 |
| 0257344 | SPC/GB98/043 | United Kingdom | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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