ORAP
LOE ApproachingNDAORALTABLET
Approved
Jul 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
2/8 — Basic
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORAP is an oral tablet approved in 1984 for an undisclosed indication. The specific mechanism of action and therapeutic class are not currently documented in available data.
LOE Approaching
Approaching loss of exclusivity with moderate competitive pressure (30%) suggests team focus is transitioning from growth maintenance to LOE mitigation strategies.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®
Started Jul 2024
54 enrolled
Healthy Participants
Sulforaphane Use to Effect Inflammatory and Metabolic Changes in Virally Suppressed HIV Patients
Started Feb 2022
20 enrolled
HIV Infections
Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients
Started Jun 2019
264 enrolled
DiabetesDiabetes Mellitus, Type 1
A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Aspart to NovoRapid® Penfill® in Healthy Subjects
Started Oct 2018
26 enrolled
Clamp Study
Vorapaxar and Lower Extremity Bypass Grafts
Started Oct 2017
0Peripheral Artery Disease
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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.