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Last Updated: May 19, 2022

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
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 64
Clinical Trials: 5
Patent Applications: 860
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 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

SponsorPhase
University of California, IrvinePhase 4
Agency for Healthcare Research and Quality (AHRQ)Phase 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process, salts, composition and use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almirall ALTABAX retapamulin OINTMENT;TOPICAL 022055-001 Apr 12, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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: See Plans and Pricing

European Patent Office

Patent: 63220
Estimated Expiration: See Plans and Pricing

Patent: 81995
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004024417
Estimated Expiration: See Plans and Pricing

Japan

Patent: 60947
Estimated Expiration: See Plans and Pricing

Patent: 85156
Estimated Expiration: See Plans and Pricing

Patent: 19331
Estimated Expiration: See Plans and Pricing

Patent: 07504231
Estimated Expiration: See Plans and Pricing

Patent: 12020998
Estimated Expiration: See Plans and Pricing

Patent: 12236850
Estimated Expiration: See Plans and Pricing

Patent: 15013882
Estimated Expiration: See Plans and Pricing

Spain

Patent: 35284
Estimated Expiration: See Plans and Pricing

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
Portugal 1930330 See Plans and Pricing
Luxembourg 91372 See Plans and Pricing
Peru 123299 DERIVADO DE PLEUROMUTILINA See Plans and Pricing
Japan 5685156 See Plans and Pricing
European Patent Office 1663220 NOUVEAU PROCEDE POUR LA FABRICATION DE DERIVES DE LA PLEUROMUTILINE (NOVEL PROCESS FOR THE PREPARATION OF PLEUROMUTILIN DERIVATIVES) See Plans and Pricing
>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 See Plans and Pricing SPC042/2007: 20080415, EXPIRES: 20220523
1028961 SPC/GB07/061 United Kingdom See Plans and Pricing 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 91372 Luxembourg See Plans and Pricing 91372, EXPIRES: 20220524
1028961 07C0057 France See Plans and Pricing 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 CA 2007 00052 Denmark See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
Boehringer Ingelheim
AstraZeneca
Dow
McKinsey

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.