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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
US Army
Argus Health
QuintilesIMS
Baxter
Harvard Business School
Citi
Daiichi Sankyo
Chubb

Generated: December 14, 2017

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Hexaminolevulinate hydrochloride - Generic Drug Details

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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.

Hexaminolevulinate hydrochloride has forty patent family members in twenty countries and nine supplementary protection certificates in five countries.

One supplier is listed for this compound.

Summary for hexaminolevulinate hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Photocure AsaCYSVIEW KIThexaminolevulinate hydrochlorideFOR SOLUTION;INTRAVESICAL022555-001May 28, 2010RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Photocure AsaCYSVIEW KIThexaminolevulinate hydrochlorideFOR SOLUTION;INTRAVESICAL022555-001May 28, 2010RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: hexaminolevulinate hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Photocure AsaCYSVIEW KIThexaminolevulinate hydrochlorideFOR SOLUTION;INTRAVESICAL022555-001May 28, 2010► Subscribe► Subscribe
Photocure AsaCYSVIEW KIThexaminolevulinate hydrochlorideFOR SOLUTION;INTRAVESICAL022555-001May 28, 2010► Subscribe► Subscribe
Photocure AsaCYSVIEW KIThexaminolevulinate hydrochlorideFOR SOLUTION;INTRAVESICAL022555-001May 28, 2010► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: hexaminolevulinate hydrochloride

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
7,850,008Esters of 5-aminolevulinic acid as photosensitizing agents in photochemotherapy► Subscribe
6,034,267 Esters of 5-aminolevulinic acid as photosensitizing agents in photochemotherapy► Subscribe
8,410,172Esters of 5-aminolevulinic acid as photosensitizing agents in photochemotherapy► Subscribe
7,335,684Esters of 5-aminolevulinic acid as photosensitizing agents in photochemotherapy► Subscribe
7,247,655Esters of 5-aminolevulinic acid as photosensitizing agents in photochemotherapy► Subscribe
7,287,646Esters of 5-aminolevulinic acid and their use as photosensitizing compounds in photochemotherapy► Subscribe
6,992,107Esters of 5-aminolevulinic acid and their use as photosensitizing compounds in photochemotherapy► Subscribe
6,492,420 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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International Patent Family for Ingredient: hexaminolevulinate hydrochloride

Country Document Number Estimated Expiration
Japan2010163445► Subscribe
Australia708076► Subscribe
Canada2215069► Subscribe
Portugal820432► Subscribe
Japan4630395► Subscribe
Hungary9800460► Subscribe
China1137087► Subscribe
Japan3955093► Subscribe
Germany69904033► Subscribe
United Kingdom9504948► 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 Certificates for Tradename: HEXAMINOLEVULINATE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0176Netherlands► Subscribe300176, 20160308, EXPIRES: 20160614
0207Netherlands► Subscribe300207, 20160308, EXPIRES: 20190916
C019/2008Ireland► SubscribeSPC019/2008: 20090219, EXPIRES: 20190916
C0010France► SubscribePRODUCT NAME: AMINOLEVULINATE DE METHYLE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 30885 20060919; FIRST REGISTRATION: SE - 16338 20010615
C/GB05/044United Kingdom► SubscribePRODUCT NAME: HEXYL AMINOLEVULINATE, OPTIONALLY IN THE FORM OF A SALT, PREFERABLY HEXYL AMINOLEVULINATE HYDROCHLORIDE; REGISTERED: SE 19227 20040917; UK PL 18952/0003 20050714
C0042France► SubscribePRODUCT NAME: HEXYL AMINOLEVULINATE; NAT. REGISTRATION NO/DATE: NL 30979 20050812; FIRST REGISTRATION: SE - 19 227 20040917
0820432/02Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
C/GB02/038United Kingdom► SubscribePRODUCT NAME: METHYL AMINOLEVULINATE, OPTIONALLY IN THE FORM OF A SALT, PREFERABLY METHYL AMINOLEVULINATE HYDROCHLORIDE; REGISTERED: SE 16338 20010615; UK PL18952/0002 20020408
C024/2002Ireland► SubscribeSPC024/2002: 20041230, EXPIRES: 20160614
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Express Scripts
US Department of Justice
Cipla
Deloitte
Daiichi Sankyo
McKinsey
QuintilesIMS
Chubb
Teva

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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