NDAORALTABLET, DELAYED RELEASE
Approved
Apr 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
5/8 — Partial
VIMOVO (esomeprazole magnesium; naproxen) by Amgen is immediate-release esomeprazole magnesium layer and an enteric-coated naproxen core. Approved for adolescent patients 12 years of age, older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and 3 more indications. First approved in 2010.
Drug data last refreshed 12h ago · AI intelligence enriched 15h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIMOVO is a fixed-dose combination of esomeprazole magnesium (proton pump inhibitor) and naproxen (NSAID) delivered via a dual-layer tablet that releases esomeprazole first in the stomach, then enteric-coated naproxen in the small intestine. It treats symptomatic arthritis in adolescents and adults while reducing the risk of naproxen-associated gastric ulcers. The mechanism works by blocking gastric acid production via H/K-ATPase inhibition while delivering NSAID analgesia with gastroprotection.
$3MPart D
LOE ApproachingProduct is in late-stage lifecycle with modest Part D spending ($3M in 2023), indicating a mature, niche market with limited team expansion opportunities.
Mechanism of Action
immediate-release esomeprazole magnesium layer and an enteric-coated naproxen core. As a result, esomeprazole is released first in the stomach, prior to the dissolution of naproxen in the small intestine. The enteric coating prevents naproxen release at pH levels below 5.5. Naproxen is a NSAID with…
Indications (6)
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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.