NDAORALCAPSULEPriority Review
Approved
Jul 1969
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
MATULANE (procarbazine hydrochloride) by Leadiant Biosciences is clinical pharmacology the precise mode of cytotoxic action of procarbazine has not been clearly defined. First approved in 1969.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MATULANE (procarbazine hydrochloride) is an oral small-molecule chemotherapy agent approved in 1969 that inhibits protein, RNA, and DNA synthesis through multiple mechanisms including transmethylation inhibition and direct DNA damage. It is primarily used in combination regimens for lymphomas and other malignancies. The drug is rapidly absorbed orally, crosses the blood-brain barrier, and is metabolized hepatically and renally.
$0.002BPart D
LOE ApproachingDeclining
Mature product with modest spending ($2M Part D in 2023) approaching loss of exclusivity, indicating a small, stable brand team focused on retention rather than growth.
Mechanism of Action
CLINICAL PHARMACOLOGY The precise mode of cytotoxic action of procarbazine has not been clearly defined. There is evidence that the drug may act by inhibition of protein, RNA and DNA synthesis. Studies have suggested that procarbazine may inhibit transmethylation of methyl groups of methionine into…
Indications
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.