Last reviewed · How we verify
NICARDIPINE HYDROCHLORIDE
Nicardipine blocks calcium ion influx into vascular smooth muscle, causing relaxation with minimal effect on cardiac muscle.
Nicardipine Hydrochloride is a marketed drug primarily indicated for chronic stable angina, with a key composition patent expiring in 2028. Its mechanism of action, which selectively blocks calcium ion influx into vascular smooth muscle, provides a significant therapeutic benefit with minimal impact on cardiac muscle, distinguishing it in the treatment landscape. The primary risk is the potential increase in generic competition following the patent expiry in 2028.
At a glance
| Generic name | NICARDIPINE HYDROCHLORIDE |
|---|---|
| Drug class | Calcium channel blocker |
| Target | Calcium ion channels |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 1988 |
Mechanism of action
Nicardipine works by blocking the entry of calcium ions into cells, particularly targeting vascular smooth muscle. This leads to relaxation of blood vessels, which can help reduce blood pressure and improve blood flow, while having minimal impact on heart muscle function.
Approved indications
- Chronic stable angina
- Hypertension
Common side effects
- Pedal Edema
- Dizziness
- Headache
- Asthenia
- Flushing
- Increased Angina
- Palpitations
- Nausea
- Dyspepsia
- Dry Mouth
- Somnolence
- Rash
Drug interactions
- Beta Blockers
- Cimetidine
- Digoxin
- Maalox TC
- Fentanyl
- Cyclosporine
- Tacrolimus
Key clinical trials
- Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma (PHASE2, PHASE3)
- Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
- Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage (PHASE4)
- Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2) (PHASE3)
- Hypotensive Anesthesia for Orthognathic Surgery (PHASE4)
- Pharmacometric Modeling of a Hospital Preparation
- A Comparison of Nicardipine and Labetalol for Blood Pressure Control in Intensive Care Patients After Hemorrhagic Stroke Brain Surgery (NA)
- Comparison of Post-Craniotomy Blood Pressure Targets (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8455524 | 2027-04-18 | Method of Use |
| 7659291 | 2027-04-18 | Method of Use |
| 11547758 | 2027-04-18 | Method of Use |
| 9364564 | 2027-12-26 | Formulation |
| 7612102 | 2027-12-26 | Formulation |
| 10758616 | 2027-04-18 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NICARDIPINE HYDROCHLORIDE CI brief — competitive landscape report
- NICARDIPINE HYDROCHLORIDE updates RSS · CI watch RSS