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Retapamulin - Generic Drug Details
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What are the generic drug sources for retapamulin and what is the scope of freedom to operate?
Retapamulin
is the generic ingredient in one branded drug marketed by Almirall and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Retapamulin has sixty-nine patent family members in thirty-five countries.
One supplier is listed for this compound.
Summary for retapamulin
International Patents: | 69 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 54 |
Clinical Trials: | 16 |
Patent Applications: | 521 |
DailyMed Link: | retapamulin at DailyMed |
Recent Clinical Trials for retapamulin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
New York University School of Medicine | Phase 3 |
GlaxoSmithKline | Phase 1 |
University of California, Irvine | Phase 4 |
Pharmacology for retapamulin
Drug Class | Pleuromutilin Antibacterial |
Synonyms for retapamulin
(1S,2R,3S,4S,6R,7R,8R,14R)-4-ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxotricyclo[5.4.3.0;{1,8}]tetradecan-6-yl 2-{[(1R,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl]sulfanyl}acetate |
(3aS,4R,5S,6S,8R,9R,9aR,10R)-2-(exo-8-Methyl-8-azabicyclo[3.2.1]octan-3-ylsulfanyl)acetic acid 5-hydroxy-4,6,9,10-tetraMethyl-1-oxo-6-vinylperhydro-3a,9-propanocyclopentacycloocten-8-yl ester (RETAPAMULIN) |
(3as,4r,5s,6s,8r,9r,9ar,10r)-5-Hydroxy-4,6,9,10-Tetramethyl-1-Oxo-6-Vinyldecahydro-3a,9-Propanocyclopenta[8]annulen-8-Yl {[(3-Exo)-8-Methyl-8-Azabicyclo[3.2.1]oct-3-Yl]thio}acetate |
(3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro-3a,9-propanocyclopenta[8]annulen-8-yl {[(3-exo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl]sulfanyl}acetate |
224452-66-8 |
345632-67-9 |
452R668 |
4MG6O8991R |
AB01566905_01 |
AKOS016008865 |
AKOS030485971 |
Altabax |
Altabax (Glaxo) |
Altargo |
AN-607 |
AS-11455 |
BC677692 |
BRD-K33082088-001-03-3 |
C30H47NO4S |
CHEMBL1658 |
CR0022 |
CS-0618 |
DB01256 |
HY-17010 |
MolPort-023-220-081 |
MP-0763 |
NCGC00386248-01 |
Retapamulin [USAN:INN:BAN] |
RL02708 |
s4056 |
SB 275833 |
SB-275833 |
SCHEMBL365459 |
ST24025747 |
UNII-4MG6O8991R |
ZINC100013500 |
ZINC103660515 |
ZINC3931840 |
US Patents and Regulatory Information for retapamulin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for retapamulin
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2015013882 | Start Trial |
Norway | 2009023 | Start Trial |
Spain | 2371205 | Start Trial |
Austria | 525373 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for retapamulin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1028961 | SPC042/2007 | Ireland | Start Trial | SPC042/2007: 20080415, EXPIRES: 20220523 |
1028961 | 07C0057 | France | Start Trial | PRODUCT NAME: RETAPAMULIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/390/001 DU 20070524; REGISTRATION NO/DATE AT EEC: EU/1/07/390/001 DU 20070524 |
1028961 | C01028961/01 | Switzerland | Start Trial | PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009 |
1028961 | SPC/GB07/061 | United Kingdom | Start Trial | PRODUCT NAME: RETAPAMULIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/390/001 20070524; UK EU/1/07/390/002 20070524; UK EU/1/07/390/003 20070524; UK EU/1/07/390/004 20070524 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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