ALTABAX Drug Patent Profile

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:	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

See drug prices for ALTABAX

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for ALTABAX

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

Pharmacology for ALTABAX

Drug Class

Pleuromutilin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for ALTABAX

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for ALTABAX

ALTABAX is protected by two US patents.

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

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
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007		RX	Yes	Yes				Y

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
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007

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

European Patent Office

Germany

Japan

Spain

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
Luxembourg	91372
Peru	123299	DERIVADO DE PLEUROMUTILINA
Japan	5685156
European Patent Office	1663220	NOUVEAU PROCEDE POUR LA FABRICATION DE DERIVES DE LA PLEUROMUTILINE (NOVEL PROCESS FOR THE PREPARATION OF PLEUROMUTILIN DERIVATIVES)

Supplementary Protection Certificates for ALTABAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1028961	SPC042/2007	Ireland		SPC042/2007: 20080415, EXPIRES: 20220523
1028961	SPC/GB07/061	United Kingdom		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		91372, EXPIRES: 20220524
1028961	07C0057	France		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