Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats chronic hepatitis B virus infection. Sold as Baraclude. Every FDA application for this active ingredient: 2 branded and 18 generic.
As of Nov 14, 2026, FDA lists 20 applications for Entecavir (sold as Baraclude), first approved Mar 29, 2005, with 16 new uses approved and 0 published complete response letters.
First approved: Mar 29, 2005
Applications: 20
New uses approved: 16
Complete response letters: 0
Medicare spending, 2025: $29.9M
First approved in the EU: Jun 26, 2006
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Entecavir
Part D
$27.4M
+1%
29,667
Baraclude
Part D
$2.5M
-4%
276
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
ENTECAVIR 0.5 MG TABLET: $0.246 per unitGeneric · +2% in a year
ENTECAVIR 1 MG TABLET: $0.358 per unitGeneric · -24% in a year
BARACLUDE 0.5 MG TABLET: $44.19 per unitBrand · +0% in a year
Approvals in the EU (EMA)
First approved in the EU 15 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Bristol Myers Squibb
Aurobindo Pharma
Cipla
Zydus Pharms
Accord Hlthcare