ALTABAX Drug Patent Profile
✉ Email this page to a colleague
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 two patents protecting this drug.
This drug has thirteen patent family members in six 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ALTABAX?
- What are the global sales for ALTABAX?
- What is Average Wholesale Price for ALTABAX?
Summary for ALTABAX
International Patents: | 13 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 5 |
Patent Applications: | 710 |
Drug Prices: | Drug price information for ALTABAX |
What excipients (inactive ingredients) are in ALTABAX? | ALTABAX excipients list |
DailyMed Link: | ALTABAX at DailyMed |
![ALTABAX drug patent expirations Drug patent expirations by year for ALTABAX](/p/graph/s/t/ALTABAX-patent-expirations.png)
![Drug Prices for ALTABAX](/p/graph/drug-price/ALTABAX.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
US Patents and Regulatory Information for ALTABAX
ALTABAX is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ALTABAX is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ALTABAX
Process salts compositions and use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Process, salts, composition and use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Almirall | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ALTABAX
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Glaxo Group Ltd | Altargo | retapamulin | EMEA/H/C/000757 Short term treatment of the following superficial skin infections:, , , impetigo;, infected small lacerations, abrasions or sutured wounds., , , See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus., , Consideration should be given to official guidance on the appropriate use of antibacterial agents., |
Withdrawn | no | no | no | 2007-05-24 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ALTABAX
See the table below for patents covering ALTABAX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1028961 | DERIVES DE PLEUROMUTILINE UTILISES COMME AGENTS ANTIMICROBIENS (PLEUROMUTILIN DERIVATIVES AS ANTIMICROBIALS) | ⤷ Sign Up |
Australia | 742167 | ⤷ Sign Up | |
Hungary | 229792 | Pleuromutilin derivatives as antimicrobials | ⤷ Sign Up |
Austria | 525373 | ⤷ Sign Up | |
China | 1283197 | ⤷ Sign Up | |
United Kingdom | 9722817 | ⤷ Sign Up | |
Poland | 191927 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALTABAX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1028961 | SPC042/2007 | Ireland | ⤷ Sign Up | SPC042/2007: 20080415, EXPIRES: 20220523 |
1028961 | 91372 | Luxembourg | ⤷ Sign Up | 91372, EXPIRES: 20220524 |
1028961 | 07C0057 | 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 |
1028961 | C01028961/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009 |
1028961 | SPC/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 |
1028961 | 306 | Finland | ⤷ Sign Up | |
1028961 | CA 2007 00052 | Denmark | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |