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 are two patents 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:	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.

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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