PROTAMINE SULFATE
LOE ApproachingNDAINTRAVENOUSSOLUTION
Approved
Aug 1969
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
PROTAMINE SULFATE by Eli Lilly and Company is clinical pharmacology: when administered alone, protamine has an anticoagulant effect. Approved for the treatment of heparin overdosage. First approved in 1969.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Protamine sulfate is a small-molecule antidote that rapidly neutralizes heparin anticoagulation by forming a stable salt complex, reversing heparin's anticoagulant activity within 5 minutes of IV administration. It is indicated for the treatment of heparin overdosage in acute clinical settings. Protamine is essential in perioperative and critical care environments where rapid heparin reversal is required.
LOE Approaching
LOE is approaching for this 1969-approved product; team size is likely lean with focus on transition planning and generic preparation.
Mechanism of Action
CLINICAL PHARMACOLOGY: When administered alone, protamine has an anticoagulant effect. However, when it is given in the presence of heparin (which is strongly acidic), a stable salt is formed and the anticoagulant activity of both drugs is lost. Protamine sulfate has a rapid onset of action.…
Indications (1)
Career Relevance
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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.