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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Dow
Boehringer Ingelheim
Citi
McKinsey
Daiichi Sankyo
Deloitte
Express Scripts
AstraZeneca

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022555

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NDA 022555 describes CYSVIEW KIT, which is a drug marketed by Photocure Asa and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the CYSVIEW KIT profile page.

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.
Summary for 022555
Tradename:CYSVIEW KIT
Applicant:Photocure Asa
Ingredient:hexaminolevulinate hydrochloride
Patents:1
Suppliers and Packaging for NDA: 022555
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYSVIEW KIT hexaminolevulinate hydrochloride FOR SOLUTION;INTRAVESICAL 022555 NDA Photocure ASA 10511-3001 N 10511-3001-2
CYSVIEW KIT hexaminolevulinate hydrochloride FOR SOLUTION;INTRAVESICAL 022555 NDA Photocure ASA 10511-3001 N 10511-3001-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;INTRAVESICALStrength100MG/VIAL
Approval Date:May 28, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 15, 2021
Regulatory Exclusivity Use: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
Patent:➤ Sign UpPatent Expiration:Nov 6, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:DETECTION OF CARCINOMA IN THE BLADDER BY PHOTODYNAMIC CYSTOSCOPY
Patent:➤ Sign UpPatent Expiration:Nov 6, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:DETECTION OF NON-MUSCLE INVASIVE PAPILLARY CANCER OF THE BLADDER BY PHOTODYNAMIC CYSTOSCOPY

Expired US Patents for NDA 022555

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

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
US Army
Fuji
Daiichi Sankyo
Covington
US Department of Justice
Queensland Health
Cipla
UBS

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