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 are three patents protecting this drug. Additional details are available on the CYSVIEW KIT profile page.
The generic ingredient in CYSVIEW KIT is hexaminolevulinate hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the hexaminolevulinate hydrochloride profile page.
The generic ingredient in CYSVIEW KIT is hexaminolevulinate hydrochloride. There is one drug master file entry for this compound. 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: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022555
Generic Entry Date for 022555*:
Constraining patent/regulatory exclusivity:
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.
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 Inc. | 10511-3001 | 10511-3001-2 | 1 KIT in 1 CARTON (10511-3001-2) * 50 mL in 1 SYRINGE, PLASTIC * 50 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;INTRAVESICAL | Strength | 100MG/VIAL | ||||
| Approval Date: | May 28, 2010 | TE: | RLD: | Yes | |||||
| Patent: | 10,556,010 | Patent Expiration: | Dec 19, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DETECTION OF CARCINOMA IN THE BLADDER BY PHOTODYNAMIC CYSTOSCOPY | ||||||||
| Patent: | 11,235,168 | Patent Expiration: | Jan 4, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DETECTION OF CARCINOMA IN THE BLADDER BY PHOTODYNAMIC CYSTOSCOPY | ||||||||
| Patent: | 11,311,620 | Patent Expiration: | Dec 19, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DETECTION OF CARCINOMA IN 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 | 6,034,267 | ⤷ Start Trial |
| Photocure Asa | CYSVIEW KIT | hexaminolevulinate hydrochloride | FOR SOLUTION;INTRAVESICAL | 022555-001 | May 28, 2010 | 7,530,461 | ⤷ Start Trial |
| Photocure Asa | CYSVIEW KIT | hexaminolevulinate hydrochloride | FOR SOLUTION;INTRAVESICAL | 022555-001 | May 28, 2010 | 7,247,655 | ⤷ Start Trial |
| Photocure Asa | CYSVIEW KIT | hexaminolevulinate hydrochloride | FOR SOLUTION;INTRAVESICAL | 022555-001 | May 28, 2010 | 7,348,361 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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