PRESTALIA
Peakamlodipine besylate; perindopril arginine
NDAORALTABLET
Approved
Jan 2015
Lifecycle
Peak
Competitive Pressure
8/100
Data completeness
4/8 — Partial
PRESTALIA (amlodipine besylate; perindopril arginine) is perindopril, a pro-drug, is hydrolyzed to perindoprilat, which inhibits ace in humans and in animals. Approved for hypertension, to lower blood pressure. First approved in 2015.
Drug data last refreshed 13h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRESTALIA is a fixed-dose combination oral tablet containing amlodipine besylate (a calcium channel blocker) and perindopril arginine (an ACE inhibitor) approved for hypertension. It works through dual mechanism: perindopril inhibits ACE to reduce angiotensin II and decrease vasoconstriction, while amlodipine blocks calcium influx into vascular smooth muscle cells to reduce peripheral vascular resistance. The combination provides synergistic blood pressure reduction in patients with hypertension.
Peak3.3 years to LOE
Product is at peak lifecycle stage with 3.3 years of patent exclusivity remaining, suggesting stable commercial operations but planning needed for LOE transition.
Mechanism of Action
Perindopril, a pro-drug, is hydrolyzed to perindoprilat, which inhibits ACE in humans and in animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of the inactive decapeptide, angiotensin I, to the vasoconstrictor substance angiotensin II. Angiotensin II is a potent peripheral…
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.