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Last Updated: December 27, 2024

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*:
Constraining patent/regulatory exclusivity:
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:DISCNDosage:OINTMENT;TOPICALStrength1%
Approval Date:Apr 12, 2007TE:RLD:Yes
Patent:⤷  SubscribePatent Expiration:Feb 14, 2027Product Flag?Substance Flag?YDelist Request?
Patent:⤷  SubscribePatent Expiration:Aug 30, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES

Expired US Patents for NDA 022055

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Almirall ALTABAX retapamulin OINTMENT;TOPICAL 022055-001 Apr 12, 2007 ⤷  Subscribe ⤷  Subscribe
Almirall ALTABAX retapamulin OINTMENT;TOPICAL 022055-001 Apr 12, 2007 ⤷  Subscribe ⤷  Subscribe
Almirall ALTABAX retapamulin OINTMENT;TOPICAL 022055-001 Apr 12, 2007 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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