Details for New Drug Application (NDA): 022055

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NDA 022055 describes ALTABAX, which is a drug marketed by Almirall and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ALTABAX profile page.

The generic ingredient in ALTABAX is retapamulin. One supplier is listed for this compound. Additional details are available on the retapamulin profile page.

Summary for 022055

Tradename:	ALTABAX
Applicant:	Almirall
Ingredient:	retapamulin
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022055

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

Pharmacology for NDA: 022055

Suppliers and Packaging for NDA: 022055

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALTABAX	retapamulin	OINTMENT;TOPICAL	022055	NDA	Almirall, LLC	16110-518	16110-518-15	1 TUBE in 1 CARTON (16110-518-15) / 15 g in 1 TUBE
ALTABAX	retapamulin	OINTMENT;TOPICAL	022055	NDA	Almirall, LLC	16110-518	16110-518-30	1 TUBE in 1 CARTON (16110-518-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;TOPICAL			Strength	1%
Approval Date:	Apr 12, 2007	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 14, 2027	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Aug 30, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES

Expired US Patents for NDA 022055

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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

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