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. There is one patent protecting this drug. Additional details are available on the ALTABAX profile page.

The generic ingredient in ALTABAX is retapamulin. Additional details are available on the retapamulin profile page.

Summary for 022055

Tradename:	ALTABAX
Applicant:	Almirall
Ingredient:	retapamulin
Patents:	1

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

Generic Entry Date for 022055^: ⤷ Get Started Free* Constraining patent/regulatory exclusivity: 7,875,630 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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;TOPICAL			Strength	1%
Approval Date:	Apr 12, 2007	TE:		RLD:	Yes
Patent:	7,875,630	Patent Expiration:	Feb 14, 2027	Product Flag?		Substance Flag?	Y	Delist Request?

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	8,207,191	⤷ Get Started Free
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007	RE43390	⤷ Get Started Free
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007	RE39128	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Summary for 022055

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

Profile for product number 001

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