Viewing data from:

ZEPATIER

NDA

ELBASVIR; GRAZOPREVIR | N208261 | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

Today

7973040

Jul. 24, 2029

8871759

May. 4, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Zepatier (2023)

Total Spending

$468K

Total Claims

Beneficiaries

Avg Cost/Unit

$273.80

Spending Trend

$6.7M(2019)→$1.1M(2020)→$616K(2021)→$343K(2022)→$468K(2023)

YoY Change:+2.8%

5yr CAGR:+0.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Dec 14, 2021	SUPPL -7	View Letter (PDF)
Dec 12, 2019	SUPPL -6	View Letter (PDF)
Jul 6, 2018	SUPPL -5	View Letter (PDF)
Nov 13, 2017	SUPPL -3	View Letter (PDF)
Feb 16, 2017	SUPPL -2	View Letter (PDF)
Jan 17, 2017	SUPPL -1	View Letter (PDF)
Jan 29, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG;100MG

RLD

2 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 28, 2016

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7973040	Jul 24, 2029	—	Yes	Yes		—
8871759	May 4, 2031	—	Yes	Yes		—