Topicort

(Desoximetasone 0.25% spray)

Small molecule

Jazz Pharmaceuticals

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Psoriasis2 trials

Effects of Desoximetasone Spray 0.25% on Moderate to Severe Plaque Psoriasis

Completed· Sun Pharmaceutical Industries, Inc. logo

Sun Pharmaceutical Industries, Inc.·Phase 3·NCT01206387·120 enrolled

Effects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis

Completed· Sun Pharmaceutical Industries, Inc. logo

Sun Pharmaceutical Industries, Inc.·Phase 3·NCT01206660·120 enrolled

LAM1 trial

Desoximetasone Spray 0.25%, Hypothalamic Pituitary Adrenal (HPA) Axis Study

Completed· Sun Pharmaceutical Industries, Inc. logo

Sun Pharmaceutical Industries, Inc.·Phase 2·NCT01043393·24 enrolled

Dermatitis1 trial

Evaluating Treatment Resistant Dermatitis TaroIIR

Completed·WWake Forest University Health Sciences·Phase 4·NCT03050294·24 enrolled

Unspecified1 trial

Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study

Completed· Sun Pharmaceutical Industries, Inc. logo

Sun Pharmaceutical Industries, Inc.·Phase 2·NCT01018134·151 enrolled

Regulatory

FDA Approval Timeline[3]

Jan 1, 1982

TOPICORT

NDA NDA017856

Jan 1, 1982

TOPICORT LP

NDA NDA018309

Mar 29, 1982

TOPICORT

NDA NDA018586

Sep 30, 1983

TOPICORT

NDA NDA018763

Jan 17, 1985

TOPICORT

NDA NDA018594

Apr 11, 2013

TOPICORT

NDA NDA204141

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Desoximetasone 0.25% spray. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Desoximetasone 0.25% spray compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA204141). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Topicort. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: Jazz Pharmaceuticals

Patent Landscape[4]

Patent Cliff

Sep 1, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8715624May 26, 2026

8277780Sep 1, 2028

Topicort

Trials by Indication[1]

Psoriasis2 trials

LAM1 trial

Dermatitis1 trial

Unspecified1 trial

FDA Approval Timeline[3]

References

Drug Info

Quick Facts

Patent Landscape[4]

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