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 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Protamine sulfate is a small-molecule heparin antagonist administered intravenously to reverse heparin anticoagulation. It works by forming a stable salt complex with heparin, neutralizing the anticoagulant activity of both drugs within 5 minutes. This product treats heparin overdosage in acute clinical settings.
LOE Approaching
As an aging product approaching loss of exclusivity with limited commercial data, team size and investment are likely minimal with focus on defending market share against incoming generic competition.
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.