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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 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
Summary for CYSVIEW KIT
| International Patents: | 10 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 47 |
| Clinical Trials: | 3 |
| Patent Applications: | 20 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CYSVIEW KIT |
| 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 |
Recent Litigation for CYSVIEW KIT
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Photocure ASA v. Dudas |
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 |
International Patents for CYSVIEW KIT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 2005019 | Start Trial |
| Canada | 2215069 | Start Trial |
| Japan | H11501914 | Start Trial |
| Hungary | 9800460 | Start Trial |
| Luxembourg | 90956 | Start Trial |
| Netherlands | 300176 | Start Trial |
| Spain | 2188146 | 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 | 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 |
