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Generated: August 23, 2017
What are the generic drug sources for hexaminolevulinate hydrochloride and what is the scope of hexaminolevulinate hydrochloride freedom to operate?
Hexaminolevulinate hydrochloride is the generic ingredient in one branded drug marketed by Photocure Asa and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 33 |
| Clinical Trials: see list | 2,268 |
| Patent Applications: see list | 88 |
| Drug Prices: | see low prices |
| DailyMed Link: | hexaminolevulinate hydrochloride at DailyMed |
| 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 | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Photocure Asa | CYSVIEW KIT | hexaminolevulinate hydrochloride | FOR SOLUTION;INTRAVESICAL | 022555-001 | May 28, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| 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 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Photocure Asa | CYSVIEW KIT | hexaminolevulinate hydrochloride | FOR SOLUTION;INTRAVESICAL | 022555-001 | May 28, 2010 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Photocure Asa | CYSVIEW KIT | hexaminolevulinate hydrochloride | FOR SOLUTION;INTRAVESICAL | 022555-001 | May 28, 2010 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,410,172 | Esters of 5-aminolevulinic acid as photosensitizing agents in photochemotherapy | ► Subscribe | |||||||||||||||||||||||||||
| 6,034,267 | Esters of 5-aminolevulinic acid as photosensitizing agents in photochemotherapy | ► Subscribe | |||||||||||||||||||||||||||
| 7,287,646 | Esters of 5-aminolevulinic acid and their use as photosensitizing compounds in photochemotherapy | ► Subscribe | |||||||||||||||||||||||||||
| 6,992,107 | Esters of 5-aminolevulinic acid and their use as photosensitizing compounds in photochemotherapy | ► Subscribe | |||||||||||||||||||||||||||
| 7,850,008 | Esters of 5-aminolevulinic acid as photosensitizing agents in photochemotherapy | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Norway | 318379 | ► Subscribe | |||||||||||||||||||||||||||
| United Kingdom | 9525822 | ► Subscribe | |||||||||||||||||||||||||||
| Netherlands | 300207 | ► Subscribe | |||||||||||||||||||||||||||
| United Kingdom | 9504948 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1178521 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0820432/02 | Switzerland | ► Subscribe | FORMER REPRESENTATIVE: BOHEST AG, CH | ||||||||||||||||||||||||||
| C/GB02/038 | United Kingdom | ► Subscribe | PRODUCT NAME: METHYL AMINOLEVULINATE, OPTIONALLY IN THE FORM OF A SALT, PREFERABLY METHYL AMINOLEVULINATE HYDROCHLORIDE; REGISTERED: SE 16338 20010615; UK PL18952/0002 20020408 | ||||||||||||||||||||||||||
| 0176 | Netherlands | ► Subscribe | 300176, 20160308, EXPIRES: 20160614 | ||||||||||||||||||||||||||
| C019/2008 | Ireland | ► Subscribe | SPC019/2008: 20090219, EXPIRES: 20190916 | ||||||||||||||||||||||||||
| C0042 | France | ► Subscribe | PRODUCT NAME: HEXYL AMINOLEVULINATE; NAT. REGISTRATION NO/DATE: NL 30979 20050812; FIRST REGISTRATION: SE - 19 227 20040917 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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