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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

71 trials from ClinicalTrials.gov, 65 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Perennial Allergic Rhinitis In Pediatric Subjects NCT00257595	Phase 3	Completed	GlaxoSmithKline	30	2005-08
Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension NCT01127620	Phase 3	Completed	Faes Farma, S.A.	650	2004-05 → 2006-11
Cetirizine Placebo Controlled Study For Perennial Allergic Rhinitis NCT00490204	Phase 3	Completed	GlaxoSmithKline	239	2007-07-27 → 2007-10-03
Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo NCT00851344	Phase 2	Completed	GlaxoSmithKline	54	2008-09 → 2008-11
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition NCT01064102	Phase 1	Completed	Dr. Reddy's Laboratories Limited	30	2006-01 → 2006-02
Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis NCT01748344	Phase 2	Completed	Ono Pharmaceutical Co., Ltd.	58	2012-11
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions NCT00881127	Phase 1	Completed	Sandoz	40	2005-07 → 2005-07
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition NCT01064115	Phase 1	Completed	Dr. Reddy's Laboratories Limited	30	2006-01 → 2006-02
A Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine NCT01103050	Phase 2	Completed	Novartis Pharmaceuticals	60	2010-03-22 → 2010-07-28
A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis NCT01916226	Phase 4	Completed	GlaxoSmithKline	682	2013-08-01 → 2013-10-17

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$7.35

per ea

Lowest NADAC/Unit

$7.35

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
82667001524ZERVIATE 0.24% EYE DROP	$7.35	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$171.50

Highest Price

$171.50

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82667-0015-24ZERVIATE 0.24% SOLN,OPH	$171.50	FSS	Harrow Eye, LLC	03/14/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Zerviate (2024)

Total Spending

$3.9M

Total Claims

10,118

Beneficiaries

3,309

Avg Cost/Unit

$7.31

Spending Trend

$1.6M(2020)→$8.2M(2021)→$4.4M(2022)→$8.6M(2023)→$3.9M(2024)

YoY Change:-11.3%

5yr CAGR:-1.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain12 active DMFs3 inactive

12 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

GRANULES INDIA LTDCETIRIZINE HYDROCHLORIDE, USP

DMF 300632016

SUPRIYA LIFESCIENCE LTDCETIRIZINE HYDROCHLORIDE USP

DMF 391992024

PRAVEEN LABORATORIES PRIVATE LTDCETIRIZINE HYDROCHLORIDE USP

DMF 435172026

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) · 2 use codes

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	—	—	—		—