Viewing data from:

QUZYTTIR

NDA

CETIRIZINE HYDROCHLORIDE | N211415 | ESTEVE PHARMACEUTICALS SA

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

2028

2029

2030

Today

Feb. 28, 2030

Feb. 28, 2030

Feb. 11, 2030

Feb. 11, 2030

Feb. 11, 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 Quzyttir (2023)

Total Spending

$616K

Total Claims

184

Beneficiaries

Avg Cost/Unit

$318.89

Spending Trend

$177K(2021)→$443K(2022)→$616K(2023)

YoY Change:+0.9%

5yr CAGR:+0.8%

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

Medicare Part B Spending

CMS physician-administered drug spending for Quzyttir (2023)

Total Spending

$548K

Total Claims

1,820

Beneficiaries

574

ASP Price

—

HCPCS: J1201 — Injection, cetirizine hydrochloride, 0.5 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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

3 letters from Drugs@FDA

Date	Submission	Document
Jul 29, 2025	SUPPL -8	View Letter (PDF)
Nov 29, 2019	SUPPL -1	View Letter (PDF)
Oct 7, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML (10MG/ML)

RLD

5 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Oct 4, 2019

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8263581	Feb 28, 2030	—	—	—	—
8314083	Feb 28, 2030	—	—	—	—
8513259	Feb 11, 2030	—	—	—	—
9119771	Feb 11, 2030	—	—	—	—
9180090	Feb 11, 2030	—	—	—	—