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ALTABAX Drug Profile
Which patents cover Altabax, and what generic alternatives are available?
Altabax is a drug marketed by Aqua Pharms Llc and is included in one NDA. There are three patents protecting this drug.
This drug has sixty-nine patent family members in thirty-five countries.
The generic ingredient in ALTABAX is retapamulin. Two suppliers are listed for this compound. Additional details are available on the retapamulin profile page.
Summary for ALTABAX
| International Patents: | 69 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 50 |
| Clinical Trials: | 5 |
| Patent Applications: | 234 |
| DailyMed Link: | ALTABAX at DailyMed |
Generic Entry Opportunity Date for ALTABAX
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for ALTABAX
| Drug Class | Pleuromutilin Antibacterial |
Synonyms for ALTABAX
| (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 |
| 224452-66-8 |
| 345632-67-9 |
| 452R668 |
| 4MG6O8991R |
| AB01566905_01 |
| AK110479 |
| AKOS016008865 |
| AKOS030485971 |
| Altabax (Glaxo) |
| Altargo |
| AN-607 |
| AS-11455 |
| BC677692 |
| C30H47NO4S |
| CR0022 |
| CS-0618 |
| DB01256 |
| HY-17010 |
| MFCD11045316 |
| MolPort-006-167-754 |
| MolPort-023-220-081 |
| MP-0763 |
| Retapamulin |
| Retapamulin [USAN:INN:BAN] |
| retpamulin |
| RL02708 |
| s4056 |
| SB 275833 |
| SB-275833 |
| SB275833 |
| SCHEMBL365459 |
| ST24025747 |
| UNII-4MG6O8991R |
| ZINC100013500 |
| ZINC103660515 |
| ZINC3931840 |
US Patents and Regulatory Information for ALTABAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aqua Pharms Llc | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Aqua Pharms Llc | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Aqua Pharms Llc | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| 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 ALTABAX
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Spain | 2335284 | ➤ Sign Up |
| Uruguay | 25225 | ➤ Sign Up |
| Japan | 2007504231 | ➤ Sign Up |
| European Patent Office | 2181995 | ➤ Sign Up |
| Australia | 9636198 | ➤ Sign Up |
| Japan | 2012020998 | ➤ Sign Up |
| Netherlands | 300304 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ALTABAX
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 1028961/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009 |
| 6 | Finland | ➤ Sign Up | |
| C/GB07/061 | United Kingdom | ➤ Sign Up | 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 |
| 372 | Luxembourg | ➤ Sign Up | 91372, EXPIRES: 20220524 |
| C042/2007 | Ireland | ➤ Sign Up | SPC042/2007: 20080415, EXPIRES: 20220523 |
| 2007 00052 | Denmark | ➤ Sign Up | |
| C0057 | France | ➤ Sign Up | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
