BLASUBCUTANEOUSINJECTABLE4 Generics Approved
Approved
Jun 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
4/8 — Partial
NOVOLOG (water injection) by Novo Nordisk. Approved for insulin analog [epc]. First approved in 2000.
Drug data last refreshed 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NOVOLOG is a rapid-acting insulin analog approved in 2000 for subcutaneous injection in patients with diabetes mellitus. It is designed to mimic the body's natural insulin response to meals and blood glucose elevation. The product is administered via injection and represents a foundational insulin therapy in diabetes management.
$517MPart D
LOE ApproachingDeclining
NOVOLOG is in late-stage maturity with imminent generic/biosimilar pressure; brand teams are shifting focus to retention and lifecycle extension strategies rather than aggressive expansion.
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 (13)
Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®
Started Jul 2024
54 enrolled
Healthy Participants
Investigation of the Analgesic Effects of Intradermal and Subdermal Sterile Water Injection on Active Labor Pain
Started Jan 2024
Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus
Started Dec 2020
137 enrolled
Type 2 Diabetes Treated With Insulin
Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Started Mar 2019
210 enrolled
Type 1 Diabetes Mellitus
Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients
Started May 2018
45 enrolled
Type 1 Diabetes Mellitus
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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.