DrugPatentWatch Database Preview
ALTABAX Drug Profile
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When do Altabax patents expire, and when can generic versions of Altabax launch?
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
| Ingredient-type | pleuromutilin |
| 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 |
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Non-Orange Book US Patents for ALTABAX
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,281,226 | Pleuromutilin derivatives as antimicrobials | ➤ Sign Up |
| RE39128 | Pleuromutilin derivatives as antimicrobials | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for ALTABAX
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Hungary | 0004040 | ➤ Sign Up |
| Portugal | 1028961 | ➤ Sign Up |
| Slovenia | 1028961 | ➤ Sign Up |
| Netherlands | 300304 | ➤ Sign Up |
| Austria | 525373 | ➤ Sign Up |
| Hong Kong | 1031376 | ➤ Sign Up |
| Argentina | 015987 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ALTABAX
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 372 | Luxembourg | ➤ Sign Up | 91372, EXPIRES: 20220524 |
| 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 |
| 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 |
| 6 | Finland | ➤ Sign Up | |
| C042/2007 | Ireland | ➤ Sign Up | SPC042/2007: 20080415, EXPIRES: 20220523 |
| 1028961/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009 |
| 2007 00052 | Denmark | ➤ Sign Up | |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
