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Express Scripts
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Boehringer Ingelheim

Last Updated: February 23, 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. 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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022055
Generic Entry Date for 022055*:
Constraining patent/regulatory exclusivity:

*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:⤷  Try a TrialPatent Expiration:Feb 14, 2027Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:Aug 30, 2024Product Flag?Substance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School

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