Valchlor

(Mechlorethamine)

Small molecule

RRECORDATI GROUP

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Treatment1 trial

HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL

Completed·SSoligenix·Phase 2·NCT06149247·10 enrolled

Lymphoma1 trial

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00003389·854 enrolled

Regulatory

FDA Approval Timeline[3]

Jan 1, 1982

MUSTARGEN

NDA NDA006695

Aug 23, 2013

VALCHLOR

NDA NDA202317

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Mechlorethamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Mechlorethamine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA202317). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Valchlor. U.S. Food & Drug Administration.
[5]
SEC EDGAR — RECORDATI GROUP company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: RRECORDATI GROUP

Patent Landscape[4]

Patent Cliff

Jul 8, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8501819Mar 7, 2026

8450375Mar 7, 2026

8501818Mar 7, 2026

7838564Mar 7, 2026

9382191Mar 7, 2026

1 more patents

7872050Jul 8, 2029