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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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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 verifification 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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