Elbasvir; Grazoprevir

Treats chronic hepatitis C virus (HCV) genotype 1 or 4 infection. Sold as Zepatier. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Elbasvir; Grazoprevir (sold as Zepatier), first approved Jan 28, 2016, with 1 new use approved and 0 published complete response letters.

First approved: Jan 28, 2016
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $189K
First approved in the EU: Jul 22, 2016

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Zepatier	Part D	$189K	-16%	0

Approvals in the EU (EMA)

First approved in the EU 6 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Zepatier, new substanceMerck Sharp & Dohme B.V. · Jul 22, 2016

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Jan 28, 2016	ZepatierNDA 208261 · New molecular entity, new combination	Msd Sub Merck	6	Discontinued

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