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 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIMOVO is a fixed-dose combination oral tablet containing esomeprazole magnesium (a proton pump inhibitor) and naproxen (an NSAID) in a delayed-release formulation. It treats symptomatic relief of arthritis in adolescents and adults while reducing the risk of naproxen-associated gastric ulcers. The mechanism pairs immediate esomeprazole release in the stomach with enteric-coated naproxen release in the small intestine, protecting against NSAID-induced gastric damage.
$0.003BPart D
LOE ApproachingDeclining
As LOE approaches, the brand team is likely contracting; career growth opportunities are limited and focused on maintaining market share against generics rather than expansion.
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.