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Retapamulin - Generic Drug Details

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What are the generic sources for retapamulin and what is the scope of freedom to operate?

Retapamulin is the generic ingredient in one branded drug marketed by Almirall and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Retapamulin has sixty-nine patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for retapamulin

International Patents:	69
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	16
Patent Applications:	1,261
What excipients (inactive ingredients) are in retapamulin?	retapamulin excipients list
DailyMed Link:	retapamulin at DailyMed

Recent Clinical Trials for retapamulin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
New York University School of Medicine	Phase 3
GlaxoSmithKline	Phase 1
Agency for Healthcare Research and Quality (AHRQ)	Phase 4

See all retapamulin clinical trials

Pharmacology for retapamulin

Drug Class

Pleuromutilin Antibacterial

ATC Classes for retapamulin

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 retapamulin

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

Expired US Patents for retapamulin

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 retapamulin

Country	Patent Number	Estimated Expiration
Norway	327392
European Patent Office	1930330
Czech Republic	20001551
World Intellectual Property Organization (WIPO)	2005023257
United Kingdom	9813689

Supplementary Protection Certificates for retapamulin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1028961	C01028961/01	Switzerland		PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009
1028961	91372	Luxembourg		91372, EXPIRES: 20220524
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	SPC042/2007	Ireland		SPC042/2007: 20080415, EXPIRES: 20220523
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