ALTABAX Drug Patent 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 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
Summary for ALTABAX
| International Patents: | 13 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 72 |
| Clinical Trials: | 5 |
| Patent Applications: | 898 |
| Drug Prices: | Drug price information for ALTABAX |
| What excipients (inactive ingredients) are in ALTABAX? | ALTABAX excipients list |
| DailyMed Link: | ALTABAX at DailyMed |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for ALTABAX
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Process, salts, composition and use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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
When does loss-of-exclusivity occur for ALTABAX?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Austria
Patent: 0535
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 63220
Estimated Expiration: ⤷ Try a Trial
Patent: 81995
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2004024417
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 60947
Estimated Expiration: ⤷ Try a Trial
Patent: 85156
Estimated Expiration: ⤷ Try a Trial
Patent: 19331
Estimated Expiration: ⤷ Try a Trial
Patent: 07504231
Estimated Expiration: ⤷ Try a Trial
Patent: 12020998
Estimated Expiration: ⤷ Try a Trial
Patent: 12236850
Estimated Expiration: ⤷ Try a Trial
Patent: 15013882
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 35284
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ALTABAX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2371205 | ⤷ Try a Trial | |
| Norway | 2009023 | ⤷ Try a Trial | |
| Poland | 340254 | ⤷ Try a Trial | |
| Germany | 69826704 | ⤷ Try a Trial | |
| Norway | 327392 | ⤷ Try a Trial | |
| >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 | ⤷ Try a Trial | SPC042/2007: 20080415, EXPIRES: 20220523 |
| 1028961 | 91372 | Luxembourg | ⤷ Try a Trial | 91372, EXPIRES: 20220524 |
| 1028961 | C01028961/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009 |
| 1028961 | CA 2007 00052 | Denmark | ⤷ Try a Trial | |
| 1028961 | 306 | Finland | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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