Teflaro

(Ceftaroline Fosamil)

ApprovedSmall molecule

AbbVie

Teflaro is one of 54 small molecule programs targeting Bacterial Pneumonia. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Bacterial PneumoniaCompleted

PneumoniaCompleted

Bacterial PneumoniaApproved

Completed

PneumoniaApproved

Completed

Competition

Competitive Landscape

155 competitors in Pneumonia

#DrugCompanyPhaseTrials

Teflaro

AbbVie

Approved

1 2

Jakafi

Incyte

Preclinical

1 3

Primaquine

Sanofi

Preclinical

1 4

Acanya

Pfizer

Preclinical

1 5

Prevacid

Takeda

Preclinical

1 6

Plaquenil

Jazz Pharmaceuticals

Preclinical

1 7

Innohep

Jazz Pharmaceuticals

Preclinical

1 8

Avlosulfon

AAlmirall, S.A.

Preclinical

4 9

Retrovir

BBp Consulting, Inc

Preclinical

2 10

Primsol

CConrado Roberto Hoffmann Filho

Preclinical

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

Clinical

Trials by Indication[1]

Skin Infection3 trials

Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

Completed· Pfizer logo

Pfizer·Phase 3·NCT01499277·802 enrolled

Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections

Completed·FForest Laboratories·Phase 2/3·NCT01400867·163 enrolled

Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.

Terminated· Pfizer logo

Pfizer·Phase 3·NCT02202135·4 enrolled

Bacterial Pneumonia3 trials

Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)

Completed·FForest Laboratories·Phase 2/3·NCT01530763·161 enrolled

Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia

Withdrawn·FForest Laboratories·Phase 4·NCT01666743

Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus

Completed·FForest Laboratories·Phase 4·NCT01645735·49 enrolled

Antibiotic Therapy1 trial

Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital

Completed·FForest Laboratories·Phase 4·NCT01298843·53 enrolled

Methicillin-resistant Staphylococcus Aureus1 trial

Safety and Efficacy Study of Ceftaroline in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia

Completed·FForest Laboratories·Phase 4·NCT01701219·56 enrolled

End-Stage Renal Disease1 trial

A Study to Assess the Pharmacokinetics of Ceftaroline in End Stage Renal Disease Patients and Matched Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01664065·15 enrolled

5 more indications

Tics1 trial

A Study to Assess Safety, Tolerability and Pharmacokinetics of Ceftaroline in Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01612507·41 enrolled

Sepsis1 trial

Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis

Terminated· Pfizer logo

Pfizer·Phase 2·NCT02424734·11 enrolled

Pneumonia1 trial

Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)

Completed·FForest Laboratories·Phase 4·NCT01669980·40 enrolled

Osteomyelitis1 trial

Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children

Completed·—·Phase 1/2·NCT02335905·11 enrolled

Unspecified1 trial

Penetration of Ceftaroline Into Cerebrospinal Fluid(CSF)

Completed·—·Phase 1·NCT02806882·10 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 29, 2010

TEFLARO

NDA NDA200327

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Ceftaroline Fosamil. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ceftaroline Fosamil compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ceftaroline Fosamil. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA200327). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Teflaro. U.S. Food & Drug Administration.
[6]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[5]

Patent Cliff

Sep 21, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9629861Sep 21, 2030

8247400Feb 10, 2031

Teflaro

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Skin Infection3 trials

Bacterial Pneumonia3 trials

Antibiotic Therapy1 trial

Methicillin-resistant Staphylococcus Aureus1 trial

End-Stage Renal Disease1 trial

Tics1 trial

Sepsis1 trial

Pneumonia1 trial

Osteomyelitis1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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