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CYSVIEW KIT Drug Profile
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» See Plans and PricingWhich 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
Summary for CYSVIEW KIT
| International Patents: | 20 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 49 |
| Clinical Trials: | 3 |
| Patent Applications: | 20 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | CYSVIEW KIT at DailyMed |
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
| Sponsor | Phase |
|---|---|
| Dr. Te Vuong | Phase 2 |
| KARL STORZ Endoscopy-America, Inc. | Phase 2 |
| KARL STORZ Endoscopy-America, Inc. | Phase 3 |
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 |
International Patents for CYSVIEW KIT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 112018012009 | Start Trial |
| Luxembourg | 90956 | Start Trial |
| Netherlands | 300176 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CYSVIEW KIT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
