Last reviewed · How we verify
amlodipine and olmesartan
Amlodipine and olmesartan, marketed by InVasc Therapeutics, Inc., is a combination therapy for hypertension with a well-established presence in the market. The key strength of this drug lies in its key composition patent, which is set to expire in 2028, providing a period of exclusivity and protection against generic competition. The primary risk is the eventual patent expiry, which could lead to increased competition from generics and potential revenue erosion.
At a glance
| Generic name | amlodipine and olmesartan |
|---|---|
| Also known as | Azor, Hydrochlorothiazide, Spironoloactone |
| Sponsor | InVasc Therapeutics, Inc. |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
- Hypertension
- Initial Therapy for Hypertension
Boxed warnings
- WARNING: FETAL TOXICITY When pregnancy is detected, discontinue amlodipine and olmesartan medoxomil tablets as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ( 5.1 , 8.1 ). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue amlodipine and olmesartan medoxomil tablets as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ).
Common side effects
- Dizziness
- Peripheral edema
- Headache
- Fatigue
- Nasopharyngitis
- Muscle spasms
- Nausea
- Upper respiratory tract infection
- Diarrhea
- Urinary tract infection
- Joint swelling
Serious adverse events
- Syncope
- Angioedema
- Anaphylactic reactions
- Asthenia
- Vomiting
Drug interactions
- Simvastatin
- Cyclosporine
- Tacrolimus
- CYP3A inhibitors (moderate and strong)
- CYP3A inducers
- Nonsteroidal anti-inflammatory drugs (NSAIDs)
- Angiotensin receptor blockers, ACE inhibitors, or aliskiren
- Colesevelam hydrochloride
- Lithium
Key clinical trials
- Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
- Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2) (PHASE2)
- Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia
- Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated Hypertension
- Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab (PHASE4)
- Multi-Omics to Predict the Blood Pressure Response to Antihypertensives (PHASE4)
- Optimal Medical Treatment of Difficult-to-treat Hypertension (PHASE4)
- Effect of Olmesartan on Angiotensin(1-7) Levels and Vascular Functions in Diabetes and Hypertension (PHASE4)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- amlodipine and olmesartan CI brief — competitive landscape report
- amlodipine and olmesartan updates RSS · CI watch RSS
- InVasc Therapeutics, Inc. portfolio CI