Viewing data from:

ZONTIVITY

NDA

VORAPAXAR SULFATE | N204886 | KEY THERAPEUTICS LLC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

7304078

Dec. 23, 2027

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 Zontivity (2023)

Total Spending

$789K

Total Claims

1,135

Beneficiaries

226

Avg Cost/Unit

$15.02

Spending Trend

$2.6M(2019)→$1.3M(2020)→$1.0M(2021)→$812K(2022)→$789K(2023)

YoY Change:+10.6%

5yr CAGR:+9.1%

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

XSPIRE PHARMA LLCVORAPAXAR SULFATE

DMF 364412021

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Nov 12, 2019	SUPPL -5	View Letter (PDF)
Apr 17, 2015	SUPPL -2	View Letter (PDF)
May 9, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2.08MG BASE

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: May 8, 2014

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7304078	Dec 23, 2027	—	Yes	Yes		—