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Last Updated: August 8, 2020

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CYSVIEW KIT Drug Profile

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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 patent family members in fourteen 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.

US ANDA Litigation and Generic Entry Outlook for Cysview Kit

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 15, 2021. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for CYSVIEW KIT
Drug patent expirations by year for CYSVIEW KIT
Generic Entry Opportunity Date for CYSVIEW KIT
Generic Entry Date for CYSVIEW KIT*:
Constraining patent/regulatory exclusivity:
ADDITIONAL INFORMATION ADDED TO THE LABELING FROM STUDY PC B308/13 REGARDING THE USE OF BLUE LIGHT CYSTOSCOPY WITH CYSVIEW AS AN ADJUNCT TO WHITE LIGHT CYSTOSCOPY
NDA:
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

SponsorPhase
KARL STORZ Endoscopy-America, Inc.Phase 2
Dr. Te VuongPhase 2
PhotocurePhase 3

See all CYSVIEW KIT clinical trials

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

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

Supplementary Protection Certificates for CYSVIEW KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0820432 05C0042 France   Start Trial PRODUCT NAME: HEXYL AMINOLEVULINATE; NAT. REGISTRATION NO/DATE: NL 30979 20050812; FIRST REGISTRATION: SE - 19 227 20040917
0820432 SPC024/2002 Ireland   Start Trial SPC024/2002: 20041230, EXPIRES: 20160614
0820432 300207 Netherlands   Start Trial 300207, 20160308, EXPIRES: 20190916
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Mallinckrodt
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Johnson and Johnson
Merck

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