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Altabax

(retapamulin)

ApprovedSmall molecule

AAlmirall, S.A.

Altabax is one of 29 small molecule programs targeting Skin Infection. It is currently in Approved.

1

Indications

10

Total Trials

0

Active Trials

28

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[3][1]

Indication

Skin InfectionActive, not recruiting

Skin InfectionApproved

Active, not recruiting

Competition

Competitive Landscape

32 competitors in Skin Infection

#DrugCompanyPhaseTrials

Keflex

Omnicef

Vancocin

HHikma Pharmaceuticals LLC

Lotrimin

Cubicin

BBaxter Healthcare Corporation

Tygacil

PPrism Pharmaceuticals

Betadine

BBecton, Dickinson and Company

Teflaro

Levaquin

Ampicillin-Sulbactam

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

MRSA2 trials

Retapamulin for Reducing MRSA Nasal Carriage

Completed·UUniversity of California, Irvine·Phase 4·NCT01461668·53 enrolled

Retapamulin as a Decolonizing Agent for MRSA

Completed·NNYU Langone Health·Phase 3·NCT03304873·47 enrolled

Trauma1 trial

Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)

Completed· GSK logo

GSK·Phase 3·NCT00684177·508 enrolled

Skin Infection1 trial

Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.

Completed· GSK logo

GSK·Phase 4·NCT00555061·60 enrolled

Dialysis1 trial

Retapamulin Microdialysis Feasibility Study

Completed· GSK logo

GSK·Phase 1·NCT01812382·3 enrolled

Methicillin-resistant Staphylococcus Aureus1 trial

Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization

Withdrawn·OOchsner Health System·Phase 4·NCT00856089

4 more indications

TED1 trial

United States Pharmacovigilence Retapamulin-Prescribing

Completed· GSK logo

GSK··NCT01153880·1 enrolled

Staphylococcus Aureus1 trial

Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus

Completed· GSK logo

GSK·Phase 2·NCT00539994·57 enrolled

Treatment1 trial

Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT01126268·38 enrolled

Unspecified1 trial

EU PV for Retapamulin-Prescribing

Completed· GSK logo

GSK··NCT01153828·1 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 12, 2007

ALTABAX

NDA NDA022055

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for retapamulin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — retapamulin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for retapamulin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022055). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Altabax. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Almirall, S.A. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAlmirall, S.A.

Patent Landscape[5]

Patent Cliff

Feb 14, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7875630Feb 14, 2027

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