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Last Updated: October 2, 2022

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 Generic Entry Opportunity 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.

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:RXDosage:OINTMENT;TOPICALStrength1%
Approval Date:Apr 12, 2007TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Feb 14, 2027Product Flag?Substance Flag?YDelist Request?
Patent:See Plans and PricingPatent 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 See Plans and Pricing See Plans and Pricing
Almirall ALTABAX retapamulin OINTMENT;TOPICAL 022055-001 Apr 12, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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