DrugPatentWatch Database Preview
ALTABAX Drug Profile
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Which patents cover Altabax, and what generic alternatives are available?
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.
DrugPatentWatch® 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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 5 |
| Patent Applications: | 780 |
| Drug Prices: | Drug price information for ALTABAX |
| What excipients (inactive ingredients) are in ALTABAX? | ALTABAX excipients list |
| DailyMed Link: | ALTABAX at DailyMed |
DrugPatentWatch® Estimated 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 |
|---|---|
| University of California, Irvine | Phase 4 |
| Agency for Healthcare Research and Quality (AHRQ) | Phase 4 |
| The University of Texas Health Science Center, Houston | Phase 4 |
Pharmacology for ALTABAX
| Drug Class | Pleuromutilin Antibacterial |
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 | Get Started for $10 | Get Started for $10 | Y | Y | Get Started for $10 | ||
| Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ALTABAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | Get Started for $10 | Get Started for $10 |
| Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | Get Started for $10 | Get Started for $10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ALTABAX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1112062 | Get Started for $10 |
| Uruguay | 25225 | Get Started for $10 |
| China | 1205211 | Get Started for $10 |
| European Patent Office | 1663220 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ALTABAX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1028961 | SPC042/2007 | Ireland | Get Started for $10 | SPC042/2007: 20080415, EXPIRES: 20220523 |
| 1028961 | C01028961/01 | Switzerland | Get Started for $10 | PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009 |
| 1028961 | 91372 | Luxembourg | Get Started for $10 | 91372, EXPIRES: 20220524 |
| 1028961 | 07C0057 | France | Get Started for $10 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
