BLASUBCUTANEOUSINJECTABLE4 Generics Approved
Approved
Jun 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
LEVEMIR FLEXPEN (insulin detemir) by Novo Nordisk. Approved for insulin analog [epc]. First approved in 2005.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Levemir FlexPen is a long-acting basal insulin analog (insulin detemir) administered subcutaneously via prefilled pen device. It is indicated for diabetes management as a once- or twice-daily basal insulin to reduce hyperglycemia in patients with type 1 and type 2 diabetes. The drug works by mimicking endogenous insulin's glucose-lowering effects with a prolonged, peakless action profile suitable for basal insulin replacement.
$1.0BPart D
LOE ApproachingDeclining
Product is approaching loss of exclusivity with moderate market presence; commercial teams should expect resource reallocation toward newer pipeline assets and biosimilar defense strategies.
Mechanism of Action
Pharmacologic Class:
Insulin Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine
Started May 2019
12,847 enrolled
Diabetes Mellitus, Type 2
Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes
Started Nov 2017
225 enrolled
DiabetesDiabetes Mellitus, Type 1
A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin
Started Jun 2014
42 enrolled
DiabetesDiabetes Mellitus, Type 2
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus
Started Oct 2013
362 enrolled
DiabetesDiabetes Mellitus, Type 1
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Started Sep 2013
2,446 enrolled
Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
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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.