CYSVIEW KIT Drug Patent Profile

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

Cysview Kit is a drug marketed by Photocure Asa and is included in one NDA. There are two patents protecting this drug.

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

The generic ingredient in CYSVIEW KIT is hexaminolevulinate hydrochloride. One supplier is listed for this compound. Additional details are available on the hexaminolevulinate hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Cysview Kit

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 19, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CYSVIEW KIT

International Patents:	27
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	3
Patent Applications:	178
Formulation / Manufacturing:	see details
DailyMed Link:	CYSVIEW KIT at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for CYSVIEW KIT

NDA:

022555

Dosage:

FOR SOLUTION;INTRAVESICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CYSVIEW KIT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
KARL STORZ Endoscopy-America, Inc.	Phase 2
Dr. Te Vuong	Phase 2
Photocure	Phase 3

See all CYSVIEW KIT clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CYSVIEW KIT

V04CX	Other diagnostic agents
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for CYSVIEW KIT

CYSVIEW KIT is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CYSVIEW KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010		RX	Yes	Yes
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010		RX	Yes	Yes

Expired US Patents for CYSVIEW KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010

International Patents for CYSVIEW KIT

When does loss-of-exclusivity occur for CYSVIEW KIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Japan

Russian Federation

South Korea

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CYSVIEW KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	3389716
Russian Federation	2018123834	СПОСОБ ФОТОДИНАМИЧЕСКОЙ ТЕРАПИИ (ФДТ) ДЛЯ РАКА МОЧЕВОГО ПУЗЫРЯ
China	108601836	用于膀胱癌的新辅助疗法 (Neoadjuvant therapy for bladder cancer)
Israel	259925	שיטת טיפול פוטודינמי עבור סרטן שלפוחית השתן (Method of photodynamic therapy (pdt) for bladder cancer)
Russian Federation	2191010	5-AMINOLEVULINIC ACID ESTERS AS PHOTOSENSIBILIZING AGENTS IN PHOTOCHEMOTHERAPY
Hungary	9800460
China	108697800	用于膀胱癌的光动力疗法（PDT）的方法 (METHOD OF PHOTODYNAMIC THERAPY (PDT) FOR BLADDER CANCER)

Supplementary Protection Certificates for CYSVIEW KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0820432	300207	Netherlands		300207, 20160308, EXPIRES: 20190916
0820432	SPC/GB05/044	United Kingdom		PRODUCT NAME: HEXYL AMINOLEVULINATE, OPTIONALLY IN THE FORM OF A SALT, PREFERABLY HEXYL AMINOLEVULINATE HYDROCHLORIDE; REGISTERED: SE 19227 20040917; UK PL 18952/0003 20050714
0820432	SPC024/2002	Ireland		SPC024/2002: 20041230, EXPIRES: 20160614
0820432	05C0042	France		PRODUCT NAME: HEXYL AMINOLEVULINATE; NAT. REGISTRATION NO/DATE: NL 30979 20050812; FIRST REGISTRATION: SE - 19 227 20040917
0820432	300176	Netherlands		300176, 20160308, EXPIRES: 20160614
0820432	SPC019/2008	Ireland		SPC019/2008: 20090219, EXPIRES: 20190916
0820432	07C0010	France		PRODUCT NAME: AMINOLEVULINATE DE METHYLE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 30885 20060919; FIRST REGISTRATION: SE - 16338 20010615