NDAORALTABLET, EXTENDED RELEASE
Approved
Jul 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
NIASPAN (niacin) by AbbVie is defined. First approved in 1997.
Drug data last refreshed 9h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NIASPAN is an extended-release oral tablet formulation of niacin approved in 1997 for dyslipidemia, hypercholesterolemia, and cardiovascular disease. It works through multiple mechanisms including partial inhibition of free fatty acid release from adipose tissue, increased lipoprotein lipase activity, and decreased hepatic synthesis of VLDL and LDL. The drug is indicated for patients requiring lipid management as part of cardiovascular risk reduction.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), indicating potential for smaller team focus on retention and cost-based strategies.
Mechanism of Action
defined. It may involve several actions including partial inhibition of release of free fatty acids from adipose tissue, and increased lipoprotein lipase activity, which may increase the rate of chylomicron triglyceride removal from plasma. Niacin decreases the rate of hepatic synthesis of VLDL and…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study on the Effectiveness of an Emollient Cream Containing Pre and Postbiotic and Niacinamide 4% in the Treatment of Skin Xerosis and Itching in Oncological Patients Treated with Anti-EGFR
Started Jul 2022
164 enrolled
Xerosis Cutis
A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
Started Jun 2012
10 enrolled
Hypercholesterolemia, FamilialHeterozygous Familial Hypercholesterolemia
Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
Started Nov 2011
99 enrolled
HIV-1 Infection
Lipid Efficacy of the Extended Release Niacin/Laropiprant Combination in Patients With Cardiovascular Disease
Started Oct 2011
32 enrolled
Coronary Artery DiseaseDyslipidemias
Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
Started Sep 2011
244 enrolled
Dyslipidemia
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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.