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AMELUZ Drug Profile

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Which patents cover Ameluz, and what substitute generic drugs are available?

Ameluz is a drug marketed by Biofrontera and is included in one NDA. There is one patent protecting this drug.

This drug has twelve patent family members in eleven countries.

The generic ingredient in AMELUZ is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.

Summary for Tradename: AMELUZ

Suppliers / Packagers: see list1
Bulk Api Vendors: see list86
Clinical Trials: see list8
Patent Applications: see list133
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:AMELUZ at DailyMed

Pharmacology for Tradename: AMELUZ

Drug ClassPorphyrin Precursor
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
aminolevulinic acid hydrochloride
GEL;TOPICAL208081-001May 10, 2016RXYesYes6,559,183► SubscribeY ► Subscribe
aminolevulinic acid hydrochloride
GEL;TOPICAL208081-001May 10, 2016RXYesYes► Subscribe► Subscribe
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International Patent Family for Tradename: AMELUZ

Country Document Number Estimated Expiration
Israel142876► Subscribe
Japan2002529495► Subscribe
European Patent Office1128812► Subscribe
Germany19852245► Subscribe
Germany59908665► 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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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.