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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. 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
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

Drug patent expirations by year for ALTABAX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALTABAX

Generic Entry Date for ALTABAX^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 022055 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

See all ALTABAX clinical trials

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

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Glossary

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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		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007		DISCN	Yes	No	⤷ 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

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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
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

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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.

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Country	Patent Number	Title	Estimated Expiration
Japan	2001521033		⤷ Sign Up
Japan	2012236850	NEW METHOD OF PREPARATION, SALT, COMPOSITION AND USE	⤷ Sign Up
Cyprus	1112062		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ALTABAX

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1028961	91372	Luxembourg	⤷ Sign Up	91372, EXPIRES: 20220524
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description