Drug

Retapamulin

As of the edition of 20 October 2026, Retapamulin is a small molecule: marketed, first approved in 2007 (US); US protection ends in 2027.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2007
Kind
Small molecule
Brand name
Altabax
First approved
12 April 2007 (US)
Approvals on record
1 in 1 region
Holder of the most recent approval
Almirall
Withdrawn from market
25 February 2019 (in some regions)
Registered trials
16, 3 stopped early
Disease areas
Infections; Skin and connective tissue; Inherited and neonatal; Immune system

US protection

US protection ends in 2027.

The last listed US drug-substance patent ends in 2027. The application that gives this date is held by Almirall.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

1 listing counts towards this date. The exact date and each listing are in the product.

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Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated3300
Phase 22101
Phase 35500
Phase 46402
All trials16

Who has held its approvals

CompanyRoleYears
GSKEarlier holder and Lead sponsor of trials2005 to now
AlmirallAcquired holder2019 to now