VERKAZIA Drug Patent Profile

Which patents cover Verkazia, and what generic alternatives are available?

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

This drug has one hundred and fifteen patent family members in twenty-three countries.

The generic ingredient in VERKAZIA is cyclosporine. There are eighteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Verkazia

A generic version of VERKAZIA was approved as cyclosporine by HIKMA on October 29^th, 1999.

Summary for VERKAZIA

International Patents:	115
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Patent Applications:	3,365
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VERKAZIA
What excipients (inactive ingredients) are in VERKAZIA?	VERKAZIA excipients list
DailyMed Link:	VERKAZIA at DailyMed

See drug prices for VERKAZIA

Pharmacology for VERKAZIA

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for VERKAZIA

VERKAZIA is protected by seven US patents and two FDA Regulatory Exclusivities.

Patents protecting VERKAZIA

FDA Regulatory Exclusivity protecting VERKAZIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes			Y
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes			Y
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes			Y
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes			Y

International Patents for VERKAZIA

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

Country	Patent Number	Title	Estimated Expiration
Israel	241753	תכשירים המכילים תרכובות אמוניום רבעוני (Compositions containing quaternary ammonium compounds)
Australia	2006301493	Ophthalmic emulsions containing prostaglandins
Hungary	E030841
Japan	2012162549	OPHTHALMIC EMULSION CONTAINING IMMUNOSUPPRESSANT
World Intellectual Property Organization (WIPO)	2008035246
Japan	2008518992

Supplementary Protection Certificates for VERKAZIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049079	PA2017003,C2049079	Lithuania		PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
2049079	PA2017003	Lithuania		PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
1809237	C300741	Netherlands		PRODUCT NAME: CICLOSPORINE (EYE DROP; REGISTRATION NO/DATE: EU/1/15/990 20150319
1809237	300741	Netherlands		PRODUCT NAME: CICLOSPORINE (EYE DROP EMULSION); REGISTRATION NO/DATE: EU/1/15/990 20150323
1809237	122015000043	Germany		PRODUCT NAME: OPHTHALMISCHE EMULSION ENTHALTEND CYCLOSPORIN; REGISTRATION NO/DATE: EU/1/15/990 20150319
1809237	CR 2015 00030	Denmark		PRODUCT NAME: CYCLOSPORIN; REG. NO/DATE: EU/1/15/990/001-002 20150323