VERKAZIA Drug Patent Profile

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Which patents cover Verkazia, and when can generic versions of Verkazia launch?

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. Nineteen 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.

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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

Drug patent expirations by year 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

Patent Number: ⤷ Sign Up
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Patented Use: FOR THE TREATMENT OF VERNAL KERATOCONJUNCTIVITIS IN CHILDREN AND ADULTS

Emulsion compositions containing quaternary ammonium compounds
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Oil-in-water type emulsion with low concentration of cationic agent and positive zeta potential
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Emulsion compositions containing quaternary ammonium compounds
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Compositions containing quaternary ammonium compounds
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Emulsion compositions containing cetalkonium chloride
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Emulsion compositions containing quaternary ammonium compounds
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FDA Regulatory Exclusivity protecting VERKAZIA

FOR THE TREATMENT OF VERNAL KERATOCONJUNCTIVITIS (VKC) IN CHILDREN AND ADULTS
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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

International Patents for VERKAZIA

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

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Country	Patent Number	Title	Estimated Expiration
South Korea	20070084107	OPHTHALMIC OIL-IN-WATER TYPE EMULSION WITH STABLE POSITIVE ZETA POTENTIAL	⤷ Sign Up
Spain	2320574		⤷ Sign Up
Spain	2351358		⤷ Sign Up
Japan	5247453		⤷ Sign Up
South Korea	101507097		⤷ Sign Up
European Patent Office	1929996	Émulsions ophtalmiques contenant un agent immunosuppresseur (Ophthalmic emulsions containing an immunosuppressive agent)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VERKAZIA

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

Summary for VERKAZIA

Pharmacology for VERKAZIA

Patents protecting VERKAZIA

FDA Regulatory Exclusivity protecting VERKAZIA

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