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Generated: December 10, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022055

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

The generic ingredient in ALTABAX is retapamulin. Two suppliers are listed for this compound. Additional details are available on the retapamulin profile page.
Summary for 022055
Tradename:ALTABAX
Applicant:Aqua Pharms Llc
Ingredient:retapamulin
Patents:3
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 Aqua Pharmaceuticals, 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 Aqua Pharmaceuticals, 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:➤ Sign UpPatent Expiration:Feb 14, 2027Product Flag?Substance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Aug 30, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES
Patent:➤ Sign UpPatent Expiration:Apr 12, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES

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