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Last Updated: May 28, 2024

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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

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Summary for ALTABAX
International Patents:13
US Patents:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 73
Clinical Trials: 5
Patent Applications: 779
Drug Prices: Drug price information for ALTABAX
What excipients (inactive ingredients) are in ALTABAX?ALTABAX excipients list
DailyMed Link:ALTABAX at DailyMed
Drug patent expirations by year for ALTABAX
Drug Prices for ALTABAX

See drug prices for ALTABAX

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ALTABAX
Generic Entry Date for ALTABAX*:
Constraining patent/regulatory exclusivity:

*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

Agency for Healthcare Research and Quality (AHRQ)Phase 4
University of California, IrvinePhase 4
The University of Texas Health Science Center, HoustonPhase 4

See all ALTABAX clinical trials

Pharmacology 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 ⤷  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

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

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
World Intellectual Property Organization (WIPO) 2005023257 ⤷  Sign Up
Poland 340254 ⤷  Sign Up
China 1205211 ⤷  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 CA 2007 00052 Denmark ⤷  Sign Up
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 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 306 Finland ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.