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Last Updated: April 4, 2020

DrugPatentWatch Database Preview

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 is one patent protecting this drug.

This drug has ten patent family members in eight 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.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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

See all CYSVIEW KIT clinical trials

Recent Litigation for CYSVIEW KIT

Identify potential future generic entrants

District Court Litigation
Case NameDate
Photocure ASA v. Dudas

See all CYSVIEW KIT litigation

Synonyms for CYSVIEW KIT
140898-91-5
5-Aminolevulinic acid hexyl ester hydrochloride
6842AA
898A915
A-6140
A15966
AK-59194
AM84373
ANW-58882
AX8102340
C11H22ClNO3
CHEMBL1201785
CS-5206
CTK8B7894
Cysview
Cysview (TN)
D04436
D4F329SL1O
DB-063352
DTXSID80161486
FT-0767765
Hexaminolevulinate (hydrochloride)
hexaminolevulinate HCl
Hexaminolevulinate Hydrochloride
Hexaminolevulinate hydrochloride (USAN)
Hexaminolevulinate Hydrochloride [USAN]
Hexaminolevulinate hydrochloride, >=98% (HPLC)
HexvisR
Hexvix
Hexyl 5-amino-4-oxopentanoate hydrochloride
hexyl 5-amino-4-oxopentanoate,hydrochloride
HY-16045
LZYXPFZBAZTOCH-UHFFFAOYSA-N
n-hexyl 5-aminolevulinate hydrochloride
OR1924
P 1206
P-1026
P-1206
Pentanoic acid, 5-amino-4-oxo-, hexyl ester, hydrochloride
Q27276092
SCHEMBL937621
TC-147627
UNII-D4F329SL1O
ZX-AT022126

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
>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 300207 Netherlands   Start Trial 300207, 20160308, EXPIRES: 20190916
0820432 SPC/GB02/038 United Kingdom   Start Trial PRODUCT NAME: METHYL AMINOLEVULINATE, OPTIONALLY IN THE FORM OF A SALT, PREFERABLY METHYL AMINOLEVULINATE HYDROCHLORIDE; REGISTERED: SE 16338 20010615; UK PL18952/0002 20020408
0820432 C00820432/02 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
0820432 SPC019/2008 Ireland   Start Trial SPC019/2008: 20090219, EXPIRES: 20190916
0820432 SPC/GB05/044 United Kingdom   Start Trial 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   Start Trial SPC024/2002: 20041230, EXPIRES: 20160614
0820432 07C0010 France   Start Trial PRODUCT NAME: AMINOLEVULINATE DE METHYLE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 30885 20060919; FIRST REGISTRATION: SE - 16338 20010615
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
Baxter
Johnson and Johnson
Merck
AstraZeneca

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