ZERVIATE Drug Patent Profile

When do Zerviate patents expire, and what generic alternatives are available?

Zerviate is a drug marketed by Harrow Eye and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-three patent family members in seven countries.

The generic ingredient in ZERVIATE is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-five suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zerviate

A generic version of ZERVIATE was approved as cetirizine hydrochloride by TEVA PHARMS on May 27^th, 2008.

Summary for ZERVIATE

International Patents:	23
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	119
Patent Applications:	2,859
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZERVIATE
What excipients (inactive ingredients) are in ZERVIATE?	ZERVIATE excipients list
DailyMed Link:	ZERVIATE at DailyMed

See drug prices for ZERVIATE

Pharmacology for ZERVIATE

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ZERVIATE

R06AE	Piperazine derivatives
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ZERVIATE

ZERVIATE is protected by four US patents.

Patents protecting ZERVIATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes					Y
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes			Y

International Patents for ZERVIATE

See the table below for patents covering ZERVIATE around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2408453
Japan	2018141022	セチリジンの眼科用製剤および使用方法 (OPHTHALMOLOGIC PREPARATION OF CETIRIZINE AND METHODS OF USE)
Japan	2020117545	セチリジンの眼科用製剤および使用方法 (OPHTHALMOLOGIC PREPARATION OF CETIRIZINE AND METHODS OF USE)

Supplementary Protection Certificates for ZERVIATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663828	C300085	Netherlands		PRODUCT NAME: LEVOCETIRIZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LEVOCETIRINE DIHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 26770 20011009; FIRST REGISTRATION: DE 49903.00.00 AND 49904.00.00 20010103
0058146	2001C/045	Belgium		PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103