Lexette

(halobetasol)

Small molecule

BBiomed Industries, Inc.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Psoriasis1 trial

Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis

Completed·AAzidus Brasil·Phase 2/3·NCT00715975·140 enrolled

Regulatory

FDA Approval Timeline[3]

Dec 17, 1990

ULTRAVATE

NDA NDA019968

Dec 27, 1990

ULTRAVATE

NDA NDA019967

Nov 6, 2015

ULTRAVATE

NDA NDA208183

May 24, 2018

LEXETTE

NDA NDA210566

Nov 6, 2018

BRYHALI

NDA NDA209355

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for halobetasol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — halobetasol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA209355). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Lexette. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Biomed Industries, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: BBiomed Industries, Inc.

Patent Landscape[4]

Patent Cliff

Nov 2, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11957753Nov 2, 2031

10478502Nov 2, 2031

11986527Nov 2, 2031

8962028Jun 19, 2033

11020407Nov 30, 2036

2 more patents

10857159Nov 30, 2036

10857159*PEDMay 30, 2037

Lexette

Trials by Indication[1]

Psoriasis1 trial

FDA Approval Timeline[3]

References

Drug Info

Quick Facts

Patent Landscape[4]

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