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METVIXIA Drug Profile

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Metvixia is a drug marketed by Galderma Labs Lp and is included in one NDA. There is one patent protecting this drug.

This drug has thirty patent family members in nineteen countries.

The generic ingredient in METVIXIA is methyl aminolevulinate hydrochloride. There are four hundred and sixty-four drug master file entries for this compound. Additional details are available on the methyl aminolevulinate hydrochloride profile page.

Summary for Tradename: METVIXIA

Patents:1
Applicants:1
NDAs:1
Bulk Api Vendors: see list56
Clinical Trials: see list2
Patent Applications: see list29
Formulation / Manufacturing:see details
Drug Prices:see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp
METVIXIA
methyl aminolevulinate hydrochloride
CREAM;TOPICAL021415-001Jul 27, 2004DISCNNo6,034,267► subscribe ► subscribe
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Expired Patents for Tradename: METVIXIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
METVIXIA
methyl aminolevulinate hydrochloride
CREAM;TOPICAL021415-001Jul 27, 20046,034,267► subscribe
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Non-Orange Book Patents for Tradename: METVIXIA

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
7,335,684Esters of 5-aminolevulinic acid as photosensitizing agents in photochemotherapy► subscribe
6,492,420 Esters of 5-aminolevulinic acid as photosensitizing agents in photochemotherapy► subscribe
8,410,172Esters 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 Tradename: METVIXIA

Country Document Number Estimated Expiration
Luxembourg90956► subscribe
Norway318379► subscribe
Norway974163► 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: METVIXIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
073Luxembourg► subscribePRODUCT NAME: ACIDE BENZOIQUE 3-{6-{-1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5-YL)CYCLOPROPANECARBONYL AMINO}-3-METHYLPYRIDIN-2-YL}, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, OU UN PRO-MEDICAMENT DE TYPE ESTER DE CELUI-CI; FIRST REGISTRATION DATE: 20151124
C/GB08/021United Kingdom► subscribePRODUCT NAME: FOSAPREPITANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE BIS(N-METHYL-D-GLUCAMINE)SALT; REGISTERED: UK EU/1/07/437/001 20080111; UK EU/1/07/437/002 20080111
C019/2008Ireland► subscribeSPC019/2008: 20090219, EXPIRES: 20190916
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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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