Viewing data from:

ZERVIATE

NDA

CETIRIZINE HYDROCHLORIDE | N208694 | HARROW EYE LLC

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)TodayPED (+6 mo)

2027

2028

2029

2030

2031

2032

2033

Today

Sep. 15, 2030

Jan. 9, 2033

Mar. 15, 2030

Mar. 15, 2030

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 Zerviate (2023)

Total Spending

$8.6M

Total Claims

20,372

Beneficiaries

6,059

Avg Cost/Unit

$8.24

Spending Trend

$1.6M(2020)→$8.2M(2021)→$4.4M(2022)→$8.6M(2023)

YoY Change:+1.4%

5yr CAGR:+1.7%

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

API Supply Chain10 active DMFs3 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

UCB PHARMA SACETIRIZINE HYDROCHLORIDE

DMF 68531987

UCB FARCHIM SACETIRIZINE HYDROCHLORIDE

DMF 175132004

MATRIX PHARMACORP PRIVATE LTDCETIRIZINE HYDROCHLORIDE USP

DMF 177412004

SOLARA ACTIVE PHARMA SCIENCES LTDCETIRIZINE HYDROCHLORIDE DIHYDROCHLORIDE USP

DMF 205392007

CALYX CHEMICALS AND PHARMACEUTICALS LTDCETIRIZINE HYDROCHLORIDE

DMF 213962008

CIMA LABORATORIES INCCETIRIZINE HYDROCHLORIDE COATED GRANULES

DMF 226802009

IPCA LABORATORIES LTDCETIRIZINE HYDROCHLORIDE USP (CZ5 PROCESS)

DMF 260332012

UNICHEM LABORATORIES LTDCETIRIZINE HYDROCHLORIDE USP

DMF 280592014

THINQ PHARMA-CRO LTDCETIRIZINE HYDROCHLORIDE USP

DMF 288872015

SUPRIYA LIFESCIENCE LTDCETIRIZINE HYDROCHLORIDE USP

DMF 391992024

IPCA LABORATORIES LTDInactiveCETIRIZINE HYDROCHLORIDE USP

DMF 209972007

IWAKI SEIYAKU CO LTDInactiveCETIRIZINE HYDROCHLORIDE

DMF 218642008

DISHMAN CARBOGEN AMCIS LTDInactiveCETIRIZINE HYDROCHLORIDE

DMF 261792012

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2020	SUPPL -6	View Letter (PDF)
Jun 2, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.24% BASE

RLD

4 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: May 30, 2017

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8829005	Mar 15, 2030PED: Sep 15, 2030	PED	—	—		—
9254286	Jul 9, 2032PED: Jan 9, 2033	PED	—	Yes	—	—
9750684	Mar 15, 2030	—	—	Yes	—	—
9993471	Mar 15, 2030	—	—	—		—