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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 Almirall 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. One supplier is listed for this compound. Additional details are available on the retapamulin profile page.
US ANDA Litigation and Generic Entry Outlook for Altabax
Altabax was eligible for patent challenges on April 12, 2011.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 14, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ALTABAX
| International Patents: | 69 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 55 |
| Clinical Trials: | 5 |
| Patent Applications: | 304 |
| Drug Prices: | Drug price information for ALTABAX |
| DailyMed Link: | ALTABAX at DailyMed |
Generic Entry Opportunity Date for ALTABAX
Generic Entry Date for ALTABAX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
OINTMENT;TOPICAL |
*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.
Recent Clinical Trials for ALTABAX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | Phase 4 |
| University of California, Irvine | Phase 4 |
| The University of Texas Health Science Center, Houston | Phase 4 |
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 |
| (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 (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 |
| Retapamulin [USAN:INN:BAN] |
| RL02708 |
| s4056 |
| SB 275833 |
| SB-275833 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 ALTABAX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | 0004040 | Start Trial |
| Colombia | 5021129 | Start Trial |
| Spain | 2371205 | Start Trial |
| Hong Kong | 1031376 | Start Trial |
| Israel | 135811 | Start Trial |
| United Kingdom | 9813689 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ALTABAX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 91372 | Luxembourg | Start Trial | 91372, EXPIRES: 20220524 |
| 1028961 | 306 | Finland | Start Trial | |
| 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 |
| 1028961 | CA 2007 00052 | Denmark | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
